Trial Outcomes & Findings for To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT) (NCT NCT03119688)

Results Overview

Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

At Baseline and Day 5 (3 hours post last wash procedure)

Results posted on

2019-05-02

Participant Flow

Participants were recruited from one center in Brazil.

A total of 89 participants were screened, out of which 39 participants did not meet the study criteria. Remaining 50 participants were enrolled in the study, out of which 2 participants were not randomized to the study due to adverse events (AEs).

Participant milestones

Participant milestones
Measure	Overall Participants All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
Overall Study STARTED	48
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Participants All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
Overall Study Adverse Event	4

Baseline Characteristics

To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=48 Participants All participants enrolled in the study received all the study products and received at least 1 wash procedure. Each participant received 9 controlled wash applications over 5 days of test product (0.09 mL), positive control (soap bar) and negative control (0.09 mL) at each allocated test site. Therefore, each participant received a total of 27 applications of study products. Each wash procedure included a 10-second application of the test product, followed by a 90-second wait and a 15-second rinse-off with sterile water.
Age, Continuous	39.1 Years STANDARD_DEVIATION 13.69 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Baseline and Day 5 (3 hours post last wash procedure)

Population: ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.

Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.

Outcome measures

Outcome measures
Measure	Test n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.	Positive Control n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.	Negative Control n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.	No Treatment n=44 Participants Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Change From Baseline in Visual Assessment of Dryness at Day 5	0.48 Score on a scale Standard Deviation 0.284	0.91 Score on a scale Standard Deviation 0.291	0.56 Score on a scale Standard Deviation 0.290	0.63 Score on a scale Standard Deviation 0.307

SECONDARY outcome

Timeframe: At Baseline and Day 5 (3 hours post last wash procedure)

Population: ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.

Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.

Outcome measures

Outcome measures
Measure	Test n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.	Positive Control n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.	Negative Control n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.	No Treatment n=44 Participants Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Change From Baseline in Visual Assessment of Redness at Day 5	0.01 Score on a scale Standard Deviation 0.075	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)

Population: ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment.

Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.

Outcome measures

Outcome measures
Measure	Test n=48 Participants Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.	Positive Control n=48 Participants Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.	Negative Control n=48 Participants Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.	No Treatment n=48 Participants Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4 Day 2	0.25 Score on a scale Standard Deviation 0.253	0.46 Score on a scale Standard Deviation 0.307	0.28 Score on a scale Standard Deviation 0.251	0.31 Score on a scale Standard Deviation 0.265
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4 Day 3	0.37 Score on a scale Standard Deviation 0.248	0.66 Score on a scale Standard Deviation 0.298	0.38 Score on a scale Standard Deviation 0.285	0.42 Score on a scale Standard Deviation 0.260
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4 Day 4	0.43 Score on a scale Standard Deviation 0.255	0.76 Score on a scale Standard Deviation 0.314	0.42 Score on a scale Standard Deviation 0.240	0.55 Score on a scale Standard Deviation 0.302

SECONDARY outcome

Timeframe: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)

Population: ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment.

Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.

Outcome measures

Outcome measures
Measure	Test n=48 Participants Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.	Positive Control n=48 Participants Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.	Negative Control n=48 Participants Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.	No Treatment n=48 Participants Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4 Day 2	0.06 Score on a scale Standard Deviation 0.167	0.05 Score on a scale Standard Deviation 0.154	0.01 Score on a scale Standard Deviation 0.072	0.01 Score on a scale Standard Deviation 0.072
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4 Day 3	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4 Day 4	0.00 Score on a scale Standard Deviation 0.00	0.01 Score on a scale Standard Deviation 0.075	0.00 Score on a scale Standard Deviation 0.00	0.02 Score on a scale Standard Deviation 0.151

SECONDARY outcome

Timeframe: At Baseline and Day 5 (3 hours post last wash procedure)

Population: ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.

TEWL was measured using Tewameter. TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belonged to the equilibration phase. The values of the last 10 sec were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.

Outcome measures

Outcome measures
Measure	Test n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where test product (0.09 ml of the cleanser) was applied during the study.	Positive Control n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where positive control (Soap bar) was applied during the study.	Negative Control n=44 Participants Data of this arm included all allotted sides of the forearms of the participants where Negative control (0.09 ml of sterile water) was applied during the study.	No Treatment n=44 Participants Data of this arm included all allotted sides of the forearms of the participants which were left untreated during the study.
Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5	0.91 g/m^2/hr Standard Deviation 2.118	1.95 g/m^2/hr Standard Deviation 2.025	0.94 g/m^2/hr Standard Deviation 1.714	0.53 g/m^2/hr Standard Deviation 1.682

SECONDARY outcome

Timeframe: At Baseline and Day 5 (3 hours post last wash procedure)

Population: ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.

Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the gold conductors of the probe an electrical field was built which allowed the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content, the stratum corneum moisturisation can be measured. The Corneometer probe was placed in contact with the skin of the paarticipant's test site for 1-2 seconds per measurement. The Corneometer measurements were taken and an average (mean) reading was calculated for each site and time point. Corneometer values lower than 30 instrumental units (i.u.) represents very dry skin, while values between 30 und 50 i.u are typically for dry skin on the forearm. An increase in Corneometer values, therefore, corresponds to a skin-moisturising effect.