Tolerability Comparison Between 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:
NCT01046565
First received: January 8, 2010
Last updated: November 15, 2011
Last verified: November 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014