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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01951417
Other study ID # GLI.04.SRE.04.US10268
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2013
Est. completion date March 2014

Study information

Verified date February 2016
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControlâ„¢ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 9 Years and older
Eligibility Inclusion Criteria: - Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling. Exclusion Criteria: - Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Adapalene/BPO Gel
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Other:
Moisturizer SPF 30
Moisturizer SPF 30 (once daily)
Foam Wash
Foam Wash (twice daily)

Locations

Country Name City State
United States Study Protocol, Inc. Boynton Beach Florida
United States Stephens & Associates Carrollton Texas
United States J&S Studies, Inc. College Station Texas
United States Tennessee Clinical Research Center Nashville Tennessee
United States The Dermatology Clinical Research Center of San Antonio San Antonio 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
Other Erythema Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. Baseline, 2, 4, and 8 weeks
Other Scaling Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. Baseline, 2, 4, and 8 weeks
Other Dryness Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. Baseline, 2, 4, and 8 weeks
Other Stinging/Burning Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. Baseline, 2, 4, and 8 weeks
Primary Total Lesion Count The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks. Baseline, 2, 4, and 8 weeks
Secondary Inflammatory Lesions The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks. Baseline, 2, 4, and 8 weeks
Secondary Non-inflammatory Lesions The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks Baseline, 2, 4, and 8 weeks
Secondary Subject Questionnaire Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. Baseline, 2, 4, and 8 weeks
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