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

July 28, 2022 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Study Protocol, Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Carrollton, Texas, United States, 75006
        • Stephens & Associates
      • College Station, Texas, United States, 77845
        • J&S Studies, Inc.
      • San Antonio, Texas, United States, 78229
        • The Dermatology Clinical Research Center of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapalene/BPO Gel/Foam Wash/Moisturizer
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Drug: Adapalene/BPO Gel
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Other Names:
  • Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump
  • Adapalene and benzoyl peroxide (BPO) gel
Other: Moisturizer SPF 30
Moisturizer SPF 30 (once daily)
Other Names:
  • Cetaphil® DermaControl™ Moisturizer SPF 30
Other: Foam Wash
Foam Wash (twice daily)
Other Names:
  • Cetaphil® DermaControl™ Foam Wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Lesion Count
Time Frame: Baseline, 2, 4, and 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Lesions
Time Frame: Baseline, 2, 4, and 8 weeks
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
Non-inflammatory Lesions
Time Frame: Baseline, 2, 4, and 8 weeks
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
Subject Questionnaire
Time Frame: Baseline, 2, 4, and 8 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythema
Time Frame: Baseline, 2, 4, and 8 weeks
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
Scaling
Time Frame: Baseline, 2, 4, and 8 weeks
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
Dryness
Time Frame: Baseline, 2, 4, and 8 weeks
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
Stinging/Burning
Time Frame: Baseline, 2, 4, and 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Joshua M Berlin, MD, Dermatology Associates, PA, of the Palm Beaches

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

September 26, 2013

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLI.04.SRE.04.US10268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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