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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01046396
Other study ID # US10149
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2010
Est. completion date February 2010

Study information

Verified date September 2012
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
adapalene cream 0.1% and adapalene lotion 0.1%
adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks
adapalene lotion 0.1%
adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Locations

Country Name City State
United States Thomas J. Stephens & Associates, Inc. Colorado Springs Colorado

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. baseline to week 3
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. week 3
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