Healthy Skin
Conditions
Brief summary
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison. The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
Detailed description
The interest & relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.
Interventions
DRUGadapalen 0.1%
Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.
OTHERCetaphil®
Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male or female subjects of Chinese origins * aged 21 years or older * with healthy skin;
Exclusion criteria
* skin pigmentation which interferes with the reading of skin reactions * with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated * with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids * with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stinging/Burning | at 4 weeks | score from 0 (none) to 3 (severe) |
| Pruritus | at 4 weeks | score from 0 (none) to 3 (severe) |
| Erythema Rating Scale | at 4 weeks | score from 0 (none) to 3 (severe) |
| Scaling | at 4 weeks | score from 0 (none) to 3 (severe) |
| Dryness | at 4 weeks | score from 0 (none) to 3 (severe) |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intra-individual Comparison Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Intra-individual Comparison |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 39.9 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment Singapore | 30 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 30 | 10 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Dryness
score from 0 (none) to 3 (severe)
Time frame: at 4 weeks
Population: safety population (APT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil + Differin | Dryness | 0.3 units on a scale | Standard Error 0.5 |
| Differin Alone | Dryness | 0.4 units on a scale | Standard Error 0.6 |
Primary
Erythema Rating Scale
score from 0 (none) to 3 (severe)
Time frame: at 4 weeks
Population: safety population (APT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil + Differin | Erythema Rating Scale | 0.6 units on a scale | Standard Error 0.7 |
| Differin Alone | Erythema Rating Scale | 0.7 units on a scale | Standard Error 0.7 |
Primary
Pruritus
score from 0 (none) to 3 (severe)
Time frame: at 4 weeks
Population: safety population (APT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil + Differin | Pruritus | 0.5 units on a scale | Standard Error 0.6 |
| Differin Alone | Pruritus | 0.6 units on a scale | Standard Error 0.7 |
Primary
Scaling
score from 0 (none) to 3 (severe)
Time frame: at 4 weeks
Population: safety population (APT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil + Differin | Scaling | 0.3 units on a scale | Standard Error 0.6 |
| Differin Alone | Scaling | 0.6 units on a scale | Standard Error 0.8 |
Primary
Stinging/Burning
score from 0 (none) to 3 (severe)
Time frame: at 4 weeks
Population: safety population (APT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetaphil + Differin | Stinging/Burning | 0.5 units on a scale | Standard Error 0.6 |
| Differin Alone | Stinging/Burning | 0.6 units on a scale | Standard Error 0.6 |