Trial Outcomes & Findings for To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function (NCT NCT03804710)

NCT ID: NCT03804710

Last Updated: 2020-06-04

Results Overview

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 158 participants
• Primary outcome timeframe: Baseline and Day 29
• Results posted on: 2020-06-04

Participant Flow

All participants were enrolled at one center in Germany.

A total 174 participants were screened, out of which 158 participants were enrolled, 149 participants were randomized and 25 participants not randomized. Out of 149 randomized participants, 7 participants did not completed study because 3 participants experienced adverse event, 3 participants withdrew consent and 1 participant due to other reason.

Participant milestones

Measure	Treatment Regimen 1 (Test Product 1 + Standard Soap) Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 milliliter (mL) × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hours (hrs).	Treatment Regimen 2 (Test Product 2 + Standard Soap) Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Overall Study STARTED	75	74
Overall Study COMPLETED	73	69
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Treatment Regimen 1 (Test Product 1 + Standard Soap) Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 milliliter (mL) × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hours (hrs).	Treatment Regimen 2 (Test Product 2 + Standard Soap) Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Overall Study Adverse Event	0	3
Overall Study Withdrawal by Subject	2	1
Overall Study Other	0	1

Baseline Characteristics

To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function

Baseline characteristics by cohort

Measure	Treatment Regimen 1 (Test Product 1 + Standard Soap) n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Treatment Regimen 2 (Test Product 2 + Standard Soap) n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants randomized to this treatment regimen and were further randomized within regimen left and right side. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Total n=149 Participants Total of all reporting groups
Age, Continuous	52.8 Years STANDARD_DEVIATION 9.64 • n=5 Participants	49.6 Years STANDARD_DEVIATION 11.98 • n=7 Participants	51.2 Years STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	74 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	73 Participants n=5 Participants	73 Participants n=7 Participants	146 Participants n=5 Participants
Fitzpatrick Skin Type Grading I - Pale white skin	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Fitzpatrick Skin Type Grading II - White skin	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Fitzpatrick Skin Type Grading III - Light brown skin	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Fitzpatrick Skin Type Grading IV - Moderate brown skin	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Fitzpatrick Skin Type Grading V - Dark brown skin	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type Grading VI - Deeply pigmented dark brown to black skin	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 29

Population: Modified Intent-to-Treat (MITT) population. Here, number analyzed indicates participants with available data for this outcome measure.

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

Outcome measures

Measure	Test Product 1 n=70 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=66 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=137 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29	-5.077 g/m^2/hr Standard Deviation 6.4082	-4.946 g/m^2/hr Standard Deviation 6.2628	-3.692 g/m^2/hr Standard Deviation 6.0635

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2).

Outcome measures

Measure	Test Product 1 n=71 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=66 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=137 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 29	-3.582 g/m^2/hr Standard Deviation 3.7399	-3.153 g/m^2/hr Standard Deviation 3.0987	-1.321 g/m^2/hr Standard Deviation 4.0207

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2).

Outcome measures

Measure	Test Product 1 n=72 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=68 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=140 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15	-4.474 g/m^2/hr Standard Deviation 6.2645	-5.963 g/m^2/hr Standard Deviation 7.0847	-3.297 g/m^2/hr Standard Deviation 5.5348

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2).

Outcome measures

Measure	Test Product 1 n=72 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=68 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=140 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15	-2.070 g/m^2/hr Standard Deviation 3.0035	-1.944 g/m^2/hr Standard Deviation 3.3337	-0.708 g/m^2/hr Standard Deviation 3.2338

SECONDARY outcome

Timeframe: Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Stratum corneum (SC) moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 international units (i.u) represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2 Day 1, 30 mins, post-dose	24.628 International units (i.u.) Standard Deviation 8.8144	12.048 International units (i.u.) Standard Deviation 9.3662	0.246 International units (i.u.) Standard Deviation 5.4461
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2 Day 1, 6 hrs	14.756 International units (i.u.) Standard Deviation 8.3951	6.760 International units (i.u.) Standard Deviation 7.3969	-0.381 International units (i.u.) Standard Deviation 6.8182
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2 Day 2, Visit 3	3.032 International units (i.u.) Standard Deviation 7.5869	1.707 International units (i.u.) Standard Deviation 6.5054	-1.765 International units (i.u.) Standard Deviation 7.7254

SECONDARY outcome

Timeframe: Baseline, Day 1 and Day 2

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2 Day 1, 6 hrs	0.762 i.u. Standard Deviation 5.2888	0.096 i.u. Standard Deviation 5.0023	-7.120 i.u. Standard Deviation 3.6854
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2 Day 2, Visit 3	2.116 i.u. Standard Deviation 5.1318	0.685 i.u. Standard Deviation 5.2522	-2.341 i.u. Standard Deviation 4.8045
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2 Day 1, 30 mins, post-dose	9.636 i.u. Standard Deviation 5.6719	7.537 i.u. Standard Deviation 5.1710	-0.934 i.u. Standard Deviation 2.5630

SECONDARY outcome

Timeframe: Baseline, Day 15 and 29

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29 Day 15, Visit 4	11.448 i.u. Standard Deviation 9.6078	11.517 i.u. Standard Deviation 8.4413	1.454 i.u. Standard Deviation 8.5126
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29 Day 29, Visit 5	13.573 i.u. Standard Deviation 9.6777	11.870 i.u. Standard Deviation 7.8857	3.506 i.u. Standard Deviation 8.4246

SECONDARY outcome

Timeframe: Baseline, Day 15 and Day 29

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29 Day 15, Visit 4	8.538 i.u. Standard Deviation 6.3133	7.452 i.u. Standard Deviation 6.7550	-1.094 i.u. Standard Deviation 5.9129
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29 Day 29, Visit 5	8.443 i.u. Standard Deviation 7.6121	8.944 i.u. Standard Deviation 8.5479	-1.273 i.u. Standard Deviation 6.7258

SECONDARY outcome

Timeframe: Baseline, Day 30, 31, 32, 33 and 34

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 34, Visit 10	-2.292 g/m^2/hr Standard Deviation 7.1913	-3.270 g/m^2/hr Standard Deviation 6.8906	-2.572 g/m^2/hr Standard Deviation 6.9373
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 31, Visit 7	-3.521 g/m^2/hr Standard Deviation 7.0138	-4.100 g/m^2/hr Standard Deviation 6.3224	-2.884 g/m^2/hr Standard Deviation 6.2981
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 30, Visit 6	-4.556 g/m^2/hr Standard Deviation 6.4520	-3.998 g/m^2/hr Standard Deviation 6.3336	-3.045 g/m^2/hr Standard Deviation 6.3823
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 32, Visit 8	-3.280 g/m^2/hr Standard Deviation 6.8111	-3.219 g/m^2/hr Standard Deviation 7.3358	-2.293 g/m^2/hr Standard Deviation 6.2826
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 33, Visit 9	-2.127 g/m^2/hr Standard Deviation 7.5335	-3.538 g/m^2/hr Standard Deviation 6.4934	-2.401 g/m^2/hr Standard Deviation 6.5692

SECONDARY outcome

Timeframe: Baseline, Day 30, 31, 32, 33 and 34

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 30, Visit 6	-3.521 g/m^2/hr Standard Deviation 4.7730	-3.061 g/m^2/hr Standard Deviation 3.0287	-1.400 g/m^2/hr Standard Deviation 4.3060
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 31, Visit 7	-3.466 g/m^2/hr Standard Deviation 5.5323	-2.752 g/m^2/hr Standard Deviation 5.0402	-1.399 g/m^2/hr Standard Deviation 4.1302
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 32, Visit 8	-3.873 g/m^2/hr Standard Deviation 3.7703	-3.237 g/m^2/hr Standard Deviation 3.6959	-1.320 g/m^2/hr Standard Deviation 3.7519
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 33, Visit 9	-3.293 g/m^2/hr Standard Deviation 5.9573	-3.348 g/m^2/hr Standard Deviation 3.3339	-0.813 g/m^2/hr Standard Deviation 4.5829
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 34, Visit 10	-3.474 g/m^2/hr Standard Deviation 5.2560	-3.327 g/m^2/hr Standard Deviation 3.4768	-0.991 g/m^2/hr Standard Deviation 3.7641

SECONDARY outcome

Timeframe: Baseline, Day 30, 31, 32, 33 and 34

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 30, Visit 6	7.279 i.u. Standard Deviation 8.0036	7.175 i.u. Standard Deviation 8.4301	2.927 i.u. Standard Deviation 8.0479
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 31, Visit 7	5.581 i.u. Standard Deviation 7.6171	4.441 i.u. Standard Deviation 8.3006	1.866 i.u. Standard Deviation 8.1570
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 32, Change at visit 8	3.948 i.u. Standard Deviation 8.6287	1.823 i.u. Standard Deviation 8.0040	0.829 i.u. Standard Deviation 8.7018
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 33, Visit 9	2.839 i.u. Standard Deviation 9.0299	1.772 i.u. Standard Deviation 7.9661	0.608 i.u. Standard Deviation 9.6741
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34 Day 34, Visit 10	1.965 i.u. Standard Deviation 10.0299	1.686 i.u. Standard Deviation 7.5388	0.682 i.u. Standard Deviation 9.2882

SECONDARY outcome

Timeframe: Baseline, Day 30, 31, 32, 33 and 34

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 30, Visit 6	4.738 i.u. Standard Deviation 6.9914	5.372 i.u. Standard Deviation 7.1154	-2.692 i.u. Standard Deviation 6.6993
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 31, Visit 7	2.943 i.u. Standard Deviation 6.6218	5.843 i.u. Standard Deviation 7.3787	-2.223 i.u. Standard Deviation 6.9870
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 32, Visit 8	2.549 i.u. Standard Deviation 6.8103	4.054 i.u. Standard Deviation 6.8908	-2.673 i.u. Standard Deviation 6.4090
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 33, Visit 9	2.135 i.u. Standard Deviation 6.1634	3.939 i.u. Standard Deviation 7.9278	-2.732 i.u. Standard Deviation 6.0150
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34 Day 34, Visit 10	3.894 i.u. Standard Deviation 6.3960	5.627 i.u. Standard Deviation 7.2834	-0.942 i.u. Standard Deviation 6.8374

SECONDARY outcome

Timeframe: Day 31

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

Tape-stripping method was used to evaluate the impact of physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge and after 3, 6, and 9 discs had been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function.

Outcome measures

Measure	Test Product 1 n=75 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=74 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29 Removal of 3 tape strips	5.52 g/m^2/hr Standard Deviation 5.762	4.86 g/m^2/hr Standard Deviation 3.339	5.59 g/m^2/hr Standard Deviation 4.421
Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29 Removal of 6 tape strips	15.64 g/m^2/hr Standard Deviation 11.883	14.28 g/m^2/hr Standard Deviation 10.510	17.46 g/m^2/hr Standard Deviation 11.698
Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29 Removal of 9 tape strips	27.18 g/m^2/hr Standard Deviation 16.425	24.33 g/m^2/hr Standard Deviation 14.524	30.74 g/m^2/hr Standard Deviation 16.715

SECONDARY outcome

Timeframe: Pre-challenge and Day 29

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure.

Tape-stripping method was used to evaluate the impact of a physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge after 3, 6, and 9 discs have been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function.

Outcome measures

Measure	Test Product 1 n=71 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=66 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29 Removal of 4 tape strips	0.822 g/m^2/hr Standard Deviation 0.8750	0.592 g/m^2/hr Standard Deviation 1.0522	1.269 g/m^2/hr Standard Deviation 1.3704
Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29 Removal of 8 tape strips	2.314 g/m^2/hr Standard Deviation 2.6847	1.832 g/m^2/hr Standard Deviation 1.5725	3.464 g/m^2/hr Standard Deviation 1.9604
Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29 Removal of 12 tape strips	3.619 g/m^2/hr Standard Deviation 1.8322	3.823 g/m^2/hr Standard Deviation 2.5310	6.740 g/m^2/hr Standard Deviation 4.3941

SECONDARY outcome

Timeframe: Day 29

Population: MITT Population.

Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nanometers (nm). Value displayed in percentage (%) was proportionally related to protein content. An 18 D-Squame discs were taken from participant (two sets of 9 discs from each side of the face). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 3 (right face) and area 4 (left face) on Day 29.

Outcome measures

Measure	Test Product 1 n=70 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=66 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Total Protein Content Extracted From D-Squame Discs From a Total of 9 Adhesive Discs on Face (Area 3 Compared to Area 4) at Day 29	91.65 Percentage (%) Standard Deviation 19.498	97.53 Percentage (%) Standard Deviation 20.882	115.36 Percentage (%) Standard Deviation 26.320

SECONDARY outcome

Timeframe: Day 29

Population: MITT Population.

Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nm. Value displayed in percentage (%) was proportionally related to protein content. An 24 D-Squame discs were taken from participant (two sets of 12 discs from the two separate sites of each lower leg). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 7 (right leg) and area 8 (left leg) on Day 29.

Outcome measures

Measure	Test Product 1 n=71 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 2 n=66 Participants Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Cleanser Soap n=149 Participants Standard cleanser (Simple pure soap) utilized for cleansing face and leg before application of either test product 1 or product 2 topically, twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Total Protein Content Extracted From D-Squame Discs From a Total of 12 Adhesive Discs on Leg (Area 7 Compared to Area 8) at Day 29	187.33 Percentage (%) Standard Deviation 30.773	201.82 Percentage (%) Standard Deviation 45.288	228.68 Percentage (%) Standard Deviation 36.005

Adverse Events

Treatment Regimen 1 (Test Product 1 + Standard Soap)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Treatment Regimen 2 (Test Product 2 + Standard Soap)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Test Product 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Test Product 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard Soap

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Regimen 1 (Test Product 1 + Standard Soap) n=75 participants at risk Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Treatment Regimen 2 (Test Product 2 + Standard Soap) n=74 participants at risk Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg after cleansing with standard cleanser to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Test Product 1 n=75 participants at risk Participants applied allocated test product 1 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs	Test Product 2 n=74 participants at risk Participants applied allocated test product 2 topically, (approximately 0.3 ml x 2 pumps = 0.6 ml, each pump contains 0.3 ml) on face and (approximately 0.3 ml x 6 pumps = 1.8 ml, each pump contains 0.3 ml) on leg to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	Standard Soap n=149 participants at risk Participants applied standard cleanser soap (for cleansing purpose) topically before applying allocated either Test Product 1 or Test Product 2 to designated side per randomization, the same side of face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Skin and subcutaneous tissue disorders Skin irritation	2.7% 2/75 • Number of events 3 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	5.4% 4/74 • Number of events 7 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 2/75 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 2/74 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 4/149 • Number of events 4 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Skin and subcutaneous tissue disorders Rash papular	4.0% 3/75 • Number of events 4 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 2/75 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.67% 1/149 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.67% 1/149 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.67% 1/149 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.67% 1/149 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/149 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Infections and infestations Nasopharyngitis	5.3% 4/75 • Number of events 4 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	8.1% 6/74 • Number of events 6 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Infections and infestations Oral herpes	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 2/74 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Infections and infestations Conjunctivitis	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Infections and infestations Rash pustular	1.3% 1/75 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.3% 1/75 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/149 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Infections and infestations Sinusitis	1.3% 1/75 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Nervous system disorders Headache	8.0% 6/75 • Number of events 7 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	6.8% 5/74 • Number of events 6 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Injury, poisoning and procedural complications Contusion	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 2/74 • Number of events 3 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Injury, poisoning and procedural complications Ligament sprain	1.3% 1/75 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Gastrointestinal disorders Toothache	2.7% 2/75 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Musculoskeletal and connective tissue disorders Back pain	2.7% 2/75 • Number of events 2 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Musculoskeletal and connective tissue disorders Myalgia	1.3% 1/75 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	0.00% 0/74 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Vascular disorders Haematoma	1.3% 1/75 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	2.7% 2/74 • Number of events 4 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Eye disorders Blepharitis	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Eye disorders Conjunctivitis allergic	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/75 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	1.4% 1/74 • Number of events 1 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.	— 0/0 • Up to Day 34 Adverse event (AE) reporting was performed on the safety population (N=149). Safety population included all randomized participants who applied at least one dose of the study product. Treatment-emergent adverse events were reported as per Treatment Regimen; Treatment Regimen 1 and Treatment Regimen 2 whereas Treatment related treatment emergent adverse events were reported as per Intervention; Test Product 1, Test Product 2 and Standard Soap. All adverse events were collected and reported.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER