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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01046396
First received: January 8, 2010
Last updated: September 21, 2012
Last verified: September 2012
  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% and adapalene lotion 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:


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 at Week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
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% and adapalene lotion 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 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 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: NCT01046396

Locations
United States, Colorado
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, United States, 80915
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: NCT01046396     History of Changes
Other Study ID Numbers: US10149
Study First Received: January 8, 2010
Results First Received: February 28, 2011
Last Updated: September 21, 2012
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 April 17, 2014