Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris

Acne Clinical Trial

Official title:

Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951417
• Other study ID #: GLI.04.SRE.04.US10268
• Status: Completed
• Phase: Phase 4
• 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
• 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® DermaControl™ 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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

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