Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01046565
Other study ID # US10145
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2010
Est. completion date February 2010

Study information

Verified date November 2011
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Thomas J. Stephens & Associates, Inc. Carrollton Texas

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 Question Subject Cosmetic Acceptability Questionnaire 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. week 3
See also
  Status Clinical Trial Phase
Completed NCT05597254 - Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation N/A
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Completed NCT04154436 - Effectiveness, Safety, and Cost Efficacy of Water (H2O) as a Substitute for Sodium Bicarbonate (NaHCO3) Plus Solution in Neutralization of Chemical Peeling Using 35% Glycolic Acid Solution N/A
Withdrawn NCT02787356 - Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging N/A
Completed NCT04449159 - Efficacy of Vinh Wellness Collagen on Skin Health N/A
Enrolling by invitation NCT06188338 - A 56-day Clinical Study on Facial Skin Rejuvenation N/A
Completed NCT01139047 - Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin Phase 4
Completed NCT01139008 - Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin Phase 4
Completed NCT05094687 - Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19).
Recruiting NCT05235997 - Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females N/A
Completed NCT01046396 - Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin Phase 1
Completed NCT04701463 - A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women N/A
Completed NCT02422836 - Tolerability and Efficacy of Anti-Aging Treatment Regimen in Subjects With Photodamage N/A
Completed NCT04002856 - Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck N/A
Completed NCT03873896 - The Skin Wrinkle Test: a Simple Clinical Test of Regional Block Success N/A
Completed NCT03505684 - Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women N/A
Active, not recruiting NCT06152718 - New Regenerative Approach for Dermal Renovation (Karisma)
Recruiting NCT04344119 - Assessment of Chilbains Occuring During Covid-19 Infection
Recruiting NCT06291415 - The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) Phase 1
Completed NCT05872178 - Omegia Softgel Clinical Research Program N/A