Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Split-Face Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

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.

Study Overview

• Status: Completed
• Conditions: Skin Manifestations
• Intervention / Treatment: Drug: adapalene cream 0.1% and adapalene lotion 0.1%; Drug: adapalene lotion 0.1%

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
      • Thomas J. Stephens & Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Differin® Cream 0.1%; Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks	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; Other Names: Differin® Cream 0.1%
Active Comparator: Differin® Lotion 0.1%; Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks	Drug: adapalene lotion 0.1%; adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks; Other Names: Differin® Lotion 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adapalene
• Other Study ID Numbers: US10149