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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Differin® Cream 0.1% | Active Comparator | Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks |
|
| Differin® Lotion 0.1% | Active Comparator | Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapalene cream 0.1% and adapalene lotion 0.1% | Drug | adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 | Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3. | week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens & Associates, Inc. | Colorado Springs | Colorado | 80915 | United States |
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.
Dates of recruitment period: First subject was enrolled on January 11, 2010 and the last subject was enrolled on January 13, 2010.
Types of location: Investigative site was located at a research center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Differin® Cream 0.1% and Differin® Lotion 0.1% | Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Differin® Cream 0.1% and Differin® Lotion 0.1% | Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol | Posted | Number | participants | baseline to week 3 |
|
3 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Differin® Cream 0.1% | Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| head cold | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment | The subjects in the Differin® Cream arm who experienced a head cold were the same as the subjects who experienced a head cold in the Differin® Lotion arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald W. Gottschalk, MD / Medical Director | Galderma Laboratories, L.P. | 817-961-5358 | ron.gottschalk@galderma.com |
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| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| adapalene lotion 0.1% | Drug | adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Differin® Lotion 0.1% | Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks |
|
|
| Secondary | 6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 | Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3. | ITT (Intent to Treat) | Posted | Number | participants | week 3 |
|
|
|
| 0 |
| 69 |
| 5 |
| 69 |
| EG001 | Differin® Lotion 0.1% | Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks | 0 | 69 | 5 | 69 |
|
The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
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| Which side had less odor? |
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| Which side felt better on your skin? |
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| Which side left less residue on your skin? |
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| Generally, which side did you prefer? |
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