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

Primary Purpose

Acne

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adapalene/BPO Gel
Moisturizer SPF 30
Foam Wash
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acne

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Study Protocol, Inc.
  • Tennessee Clinical Research Center
  • Stephens & Associates
  • J&S Studies, Inc.
  • The Dermatology Clinical Research Center of San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adapalene/BPO Gel/Foam Wash/Moisturizer

Arm Description

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Subject Questionnaire
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

Full Information

First Posted
September 23, 2013
Last Updated
July 28, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01951417
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapalene/BPO Gel/Foam Wash/Moisturizer
Arm Type
Experimental
Arm Description
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Intervention Type
Drug
Intervention Name(s)
Adapalene/BPO Gel
Other Intervention Name(s)
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump, Adapalene and benzoyl peroxide (BPO) gel
Intervention Description
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Intervention Type
Other
Intervention Name(s)
Moisturizer SPF 30
Other Intervention Name(s)
Cetaphil® DermaControl™ Moisturizer SPF 30
Intervention Description
Moisturizer SPF 30 (once daily)
Intervention Type
Other
Intervention Name(s)
Foam Wash
Other Intervention Name(s)
Cetaphil® DermaControl™ Foam Wash
Intervention Description
Foam Wash (twice daily)
Primary Outcome Measure Information:
Title
Total Lesion Count
Description
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.
Time Frame
Baseline, 2, 4, and 8 weeks
Secondary Outcome Measure Information:
Title
Inflammatory Lesions
Description
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.
Time Frame
Baseline, 2, 4, and 8 weeks
Title
Non-inflammatory Lesions
Description
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
Time Frame
Baseline, 2, 4, and 8 weeks
Title
Subject Questionnaire
Description
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time Frame
Baseline, 2, 4, and 8 weeks
Other Pre-specified Outcome Measures:
Title
Erythema
Description
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.
Time Frame
Baseline, 2, 4, and 8 weeks
Title
Scaling
Description
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.
Time Frame
Baseline, 2, 4, and 8 weeks
Title
Dryness
Description
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.
Time Frame
Baseline, 2, 4, and 8 weeks
Title
Stinging/Burning
Description
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.
Time Frame
Baseline, 2, 4, and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M Berlin, MD
Organizational Affiliation
Dermatology Associates, PA, of the Palm Beaches
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study Protocol, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Stephens & Associates
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
The Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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