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

NCT01046565 | Completed Phase 1 Results

• 1 other identifier: US10145
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Manifestations

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• 6 Question Subject Cosmetic Acceptability Questionnaire

  week 3

Study Arms (2)

Differin® Cream 0.1%

ACTIVE COMPARATOR

Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks

Drug: adapalene cream 0.1%

Differin® Lotion 0.1%

ACTIVE COMPARATOR

adapalene lotion 0.1% - apply once daily on the opposite side of the face

Drug: adapalene lotion 0.1%

Interventions

adapalene cream 0.1% DRUG

adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks

Also known as: Differin® Cream 0.1%

Differin® Cream 0.1%

adapalene lotion 0.1% DRUG

adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Also known as: Differin Lotion 0.1%

Differin® Lotion 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 years and older
• Subjects with healthy skin as determined by the clinical grader.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Thomas J. Stephens & Associates, Inc.

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Skin Manifestations

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ronald W. Gottschalk, MD / Medical Director
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 25, 2022
• Results First Posted: May 2, 2011

Record last verified: 2011-11

Locations

US (1)