Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin - Full Text View

Purpose

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.

Condition	Intervention	Phase
Skin Manifestations	Drug: adapalene cream 0.1% Drug: adapalene lotion 0.1%	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Split-Face Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Resource links provided by NLM:

Drug Information available for: Adapalene

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

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. [ Time Frame: baseline to week 3 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.

Enrollment:	75
Study Start Date:	January 2010
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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% adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks Other Name: Differin® Cream 0.1%
Active Comparator: Differin® Lotion 0.1% adapalene lotion 0.1% - apply once daily on the opposite side of the face	Drug: adapalene lotion 0.1% adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks Other Name: Differin Lotion 0.1%

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046565

Locations

United States, Texas
Thomas J. Stephens & Associates, Inc.
Carrollton, Texas, United States, 75006

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT01046565 History of Changes
Other Study ID Numbers:	US10145
Study First Received:	January 8, 2010
Results First Received:	February 28, 2011
Last Updated:	November 15, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Skin Manifestations
Signs and Symptoms
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013