Skin Manifestations
Conditions
Brief summary
The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.
Interventions
adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks
adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males or females aged 18 years and older * Subjects with healthy skin as determined by the clinical grader.
Exclusion criteria
* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions. * Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study * Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%) * Subjects who have participated in another investigational drug or device research study within 30 days of enrollment. * Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids. * Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids. * Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated. * Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | baseline to week 3 | Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Question Subject Cosmetic Acceptability Questionnaire | week 3 | Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: First subject was enrolled on January 11, 2010 and the last subject was enrolled on January 11, 2010. Types of location: Investigative site was located at a research center.
Pre-assignment details
Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment, it was less than 1 week for medications that may have increased photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
Participants by arm
| Arm | Count |
|---|---|
| Differin® Lotion 0.1% and Differin Cream 0.1% Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Differin® Lotion 0.1% and Differin Cream 0.1% |
|---|---|
| Age, Continuous | 44.75 years STANDARD_DEVIATION 13.39 |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.
Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.
Time frame: baseline to week 3
Population: Per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Differin® Lotion 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Erythema | 35 participants |
| Differin® Lotion 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Scaling | 58 participants |
| Differin® Lotion 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Dryness | 46 participants |
| Differin® Lotion 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Stinging/Burning | 57 participants |
| Differin Cream 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Stinging/Burning | 60 participants |
| Differin Cream 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Erythema | 33 participants |
| Differin Cream 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Dryness | 44 participants |
| Differin Cream 0.1% | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Scaling | 61 participants |
Secondary
6 Question Subject Cosmetic Acceptability Questionnaire
Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.
Time frame: week 3
Population: ITT (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Differin® Lotion 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side was easier to apply? | 17 participants |
| Differin® Lotion 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side absorbed into your skin more quickly? | 25 participants |
| Differin® Lotion 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side had less odor? | 7 participants |
| Differin® Lotion 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side felt better on your skin? | 27 participants |
| Differin® Lotion 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side left less residue on your skin? | 15 participants |
| Differin® Lotion 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Generally, which side did you prefer? | 26 participants |
| Differin Cream 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Generally, which side did you prefer? | 23 participants |
| Differin Cream 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side was easier to apply? | 14 participants |
| Differin Cream 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side felt better on your skin? | 22 participants |
| Differin Cream 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side left less residue on your skin? | 22 participants |
| Differin Cream 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side absorbed into your skin more quickly? | 23 participants |
| Differin Cream 0.1% | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side had less odor? | 4 participants |
| No Preference | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side absorbed into your skin more quickly? | 27 participants |
| No Preference | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side had less odor? | 64 participants |
| No Preference | 6 Question Subject Cosmetic Acceptability Questionnaire | Generally, which side did you prefer? | 26 participants |
| No Preference | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side felt better on your skin? | 26 participants |
| No Preference | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side was easier to apply? | 44 participants |
| No Preference | 6 Question Subject Cosmetic Acceptability Questionnaire | Which side left less residue on your skin? | 38 participants |