Trial Outcomes & Findings for Effect of a Basic Skin Care Product on the Structural Strength of the Skin (NCT NCT03625167)
NCT ID: NCT03625167
Last Updated: 2025-02-19
Results Overview
Duration from the start of suction pressure to the development of a full blister (measured in minutes)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Day 28±2, Day 56±2
Results posted on
2025-02-19
Participant Flow
Unit of analysis: Forearms
Participant milestones
| Measure |
Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment
In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.
Treatment with petrolatum: Petrolatum is applied twice daily to the intervention arm.
|
|---|---|
|
Overall Study
STARTED
|
17 34
|
|
Overall Study
COMPLETED
|
12 24
|
|
Overall Study
NOT COMPLETED
|
5 10
|
Reasons for withdrawal
| Measure |
Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment
In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.
Treatment with petrolatum: Petrolatum is applied twice daily to the intervention arm.
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
Baseline Characteristics
Effect of a Basic Skin Care Product on the Structural Strength of the Skin
Baseline characteristics by cohort
| Measure |
Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment
n=24 Volar forearm
In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.
|
|---|---|
|
Age, Continuous
Age
|
70.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 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
|
|
Region of Enrollment
Germany
|
12 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.0 kg/m^2
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Skin phototype (Fitzpatrick scale)
Type II
|
3 Participants
n=5 Participants
|
|
Skin phototype (Fitzpatrick scale)
Type III
|
9 Participants
n=5 Participants
|
|
Body temperature
|
36.3 degree Celsius
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Blood pressure
Systolic
|
127 mmHg
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Blood pressure
Diastolic
|
83 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28±2, Day 56±2Duration from the start of suction pressure to the development of a full blister (measured in minutes)
Outcome measures
| Measure |
Intervention: Treatment With Petrolatum
n=12 Volar forearm
Petrolatum was applied twice daily to the randomized volar forearm
|
Control: No Treatment
n=12 Volar forearm
The control forearm remained untreated throughout the study
|
|---|---|---|
|
Blistering Time (Full Blister)
Blistering Time (Full Blister) Day 28±2
|
63 Minutes
Interval 53.0 to 94.0
|
54 Minutes
Interval 45.0 to 71.0
|
|
Blistering Time (Full Blister)
Blistering Time (Full Blister) Day 56±2
|
65 Minutes
Interval 49.0 to 75.0
|
62 Minutes
Interval 42.0 to 73.0
|
PRIMARY outcome
Timeframe: Day 28±2, Day 56±2Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)
Outcome measures
| Measure |
Intervention: Treatment With Petrolatum
n=12 Volar forearm
Petrolatum was applied twice daily to the randomized volar forearm
|
Control: No Treatment
n=12 Volar forearm
The control forearm remained untreated throughout the study
|
|---|---|---|
|
Blistering Time (First Vesicles)
Blistering Time (First Vesicles) Day 28±2
|
43 Minutes
Interval 29.0 to 69.0
|
39 Minutes
Interval 25.0 to 76.0
|
|
Blistering Time (First Vesicles)
Blistering Time (First Vesicles) Day 56±2
|
47 Minutes
Interval 32.0 to 69.0
|
27 Minutes
Interval 24.0 to 60.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28±2, Day 56±2Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm
Outcome measures
| Measure |
Intervention: Treatment With Petrolatum
n=12 Volar forearm
Petrolatum was applied twice daily to the randomized volar forearm
|
Control: No Treatment
n=12 Volar forearm
The control forearm remained untreated throughout the study
|
|---|---|---|
|
Epidermal Thickness
Epidermal Thickness (Day 56±2)
|
75 micrometres (μm)
Interval 62.0 to 79.0
|
71 micrometres (μm)
Interval 65.0 to 77.0
|
|
Epidermal Thickness
Epidermal Thickness (Baseline)
|
78 micrometres (μm)
Interval 65.0 to 86.0
|
68 micrometres (μm)
Interval 63.0 to 80.0
|
|
Epidermal Thickness
Epidermal Thickness (Day 28±2)
|
68 micrometres (μm)
Interval 60.0 to 84.0
|
72 micrometres (μm)
Interval 63.0 to 79.0
|
SECONDARY outcome
Timeframe: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2Stratum corneum hydration (SCH) was measured with Corneometer® CM 825 (Courage \& Khazaka electronic GmbH, Cologne, Germany) and expressed in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer.
Outcome measures
| Measure |
Intervention: Treatment With Petrolatum
n=12 Volar forearm
Petrolatum was applied twice daily to the randomized volar forearm
|
Control: No Treatment
n=12 Volar forearm
The control forearm remained untreated throughout the study
|
|---|---|---|
|
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (AU) Baseline
|
43 Arbitrary Units
Interval 35.0 to 49.0
|
40 Arbitrary Units
Interval 35.0 to 47.0
|
|
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (AU) Day 14±1
|
41 Arbitrary Units
Interval 40.0 to 46.0
|
36 Arbitrary Units
Interval 34.0 to 40.0
|
|
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (AU) Day 28±2
|
39 Arbitrary Units
Interval 36.0 to 44.0
|
36 Arbitrary Units
Interval 33.0 to 39.0
|
|
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (AU) Day 42±2
|
38 Arbitrary Units
Interval 35.0 to 43.0
|
36 Arbitrary Units
Interval 33.0 to 37.0
|
|
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (AU) Day 56±2
|
41 Arbitrary Units
Interval 33.0 to 48.0
|
35 Arbitrary Units
Interval 32.0 to 41.0
|
SECONDARY outcome
Timeframe: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2Epidermal Moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Outcome measures
| Measure |
Intervention: Treatment With Petrolatum
n=12 Volar forearm
Petrolatum was applied twice daily to the randomized volar forearm
|
Control: No Treatment
n=12 Volar forearm
The control forearm remained untreated throughout the study
|
|---|---|---|
|
Epidermal Hydratation: Epidermal Moisture
Epidermal Moisture (%) Day 42±2
|
46 percentage of tissue water
Interval 42.0 to 58.0
|
42 percentage of tissue water
Interval 38.0 to 50.0
|
|
Epidermal Hydratation: Epidermal Moisture
Epidermal Moisture (%) Baseline
|
47 percentage of tissue water
Interval 39.0 to 54.0
|
46 percentage of tissue water
Interval 38.0 to 54.0
|
|
Epidermal Hydratation: Epidermal Moisture
Epidermal Moisture (%) Day 14±1
|
46 percentage of tissue water
Interval 42.0 to 48.0
|
41 percentage of tissue water
Interval 37.0 to 46.0
|
|
Epidermal Hydratation: Epidermal Moisture
Epidermal Moisture (%) Day 28±2
|
43 percentage of tissue water
Interval 42.0 to 49.0
|
41 percentage of tissue water
Interval 38.0 to 48.0
|
|
Epidermal Hydratation: Epidermal Moisture
Epidermal Moisture (%) Day 56±2
|
47 percentage of tissue water
Interval 42.0 to 50.0
|
42 percentage of tissue water
Interval 40.0 to 43.0
|
Adverse Events
Intervention: Treatment With Petrolatum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control: No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Monira El Genedy-Kalyoncu
Charité - Universitätsmedizin Berlin
Phone: +49 30 450 529 434
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place