Back to resultsTolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Primary Purpose
Skin Manifestations
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
adapalene cream 0.1% and adapalene lotion 0.1%
adapalene lotion 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Skin Manifestations
Eligibility Criteria
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.)
Sites / Locations
- Thomas J. Stephens & Associates, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Differin® Cream 0.1%
Differin® Lotion 0.1%
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01046396
Brief Title
Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Official Title
Split-Face Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Manifestations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Differin® Cream 0.1%
Arm Type
Active Comparator
Arm Description
Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks
Arm Title
Differin® Lotion 0.1%
Arm Type
Active Comparator
Arm Description
Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
Intervention Type
Drug
Intervention Name(s)
adapalene cream 0.1% and adapalene lotion 0.1%
Other Intervention Name(s)
Differin® Cream 0.1%
Intervention Description
adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks
Intervention Type
Drug
Intervention Name(s)
adapalene lotion 0.1%
Other Intervention Name(s)
Differin® Lotion 0.1%
Intervention Description
adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3
Description
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.
Time Frame
week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Thomas J. Stephens & Associates, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
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