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Completed

NCT Number: NCT01046396

Tolerability Comparison of 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.

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Key information

Conditions

Skin Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

adapalene cream 0.1% and adapalene lotion 0.1%

Drug

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

Other names: 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

Other names: Differin® Lotion 0.1%

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.

    Time frame: 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.

Secondary outcomes

  1. 6 Question Subject Cosmetic Acceptability Questionnaire at Week 3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2010
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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