Clinical trial NCT01951417: Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 81
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Lesion Count
timeFrame: Baseline, 2, 4, and 8 weeks
Secondary outcomes:
measure: Inflammatory Lesions
timeFrame: Baseline, 2, 4, and 8 weeks
measure: Non-inflammatory Lesions
timeFrame: Baseline, 2, 4, and 8 weeks
measure: Subject Questionnaire
timeFrame: Baseline, 2, 4, and 8 weeks
Other outcomes:
measure: Erythema
timeFrame: Baseline, 2, 4, and 8 weeks
measure: Scaling
timeFrame: Baseline, 2, 4, and 8 weeks
measure: Dryness
timeFrame: Baseline, 2, 4, and 8 weeks
measure: Stinging/Burning
timeFrame: Baseline, 2, 4, and 8 weeks
Locations:
city: Boynton Beach
country: United States
facility: Study Protocol, Inc.
state: Florida
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Carrollton
country: United States
facility: Stephens & Associates
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: San Antonio
country: United States
facility: The Dermatology Clinical Research Center of San Antonio
state: Texas
Study officials:
affiliation: Dermatology Associates, PA, of the Palm Beaches
name: Joshua M Berlin, MD
role: PRINCIPAL_INVESTIGATOR
References: