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Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (FREE)

Primary Purpose

Acne

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Adapalene BPO Gel standard daily overnight application
Adapalene-BPO 3-hour daily application before bedtime
Adapalene-BPO Gel every other day application
Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female Subjects of any race, aged 12 to 35 years inclusive
  • Subjects with mild or moderate facial acne vulgaris
  • Subjects with skin phototype I to IV

Exclusion Criteria:

  • Subjects with more than 1 nodules or cysts on the face,
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks

Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Outcomes

Primary Outcome Measures

Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2009
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00883233
Brief Title
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Acronym
FREE
Official Title
Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
Arm Title
4
Arm Type
Active Comparator
Arm Description
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Intervention Type
Drug
Intervention Name(s)
Adapalene BPO Gel standard daily overnight application
Other Intervention Name(s)
Standard
Intervention Description
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Intervention Type
Drug
Intervention Name(s)
Adapalene-BPO 3-hour daily application before bedtime
Other Intervention Name(s)
3-hour before bedtime
Intervention Description
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
Intervention Type
Drug
Intervention Name(s)
Adapalene-BPO Gel every other day application
Other Intervention Name(s)
every other day
Intervention Description
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
Intervention Type
Drug
Intervention Name(s)
Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Other Intervention Name(s)
Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion
Intervention Description
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
Primary Outcome Measure Information:
Title
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
Description
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Subjects of any race, aged 12 to 35 years inclusive Subjects with mild or moderate facial acne vulgaris Subjects with skin phototype I to IV Exclusion Criteria: Subjects with more than 1 nodules or cysts on the face, Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Tan, MD
Organizational Affiliation
Windsor, ON, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galderma Investigational Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Galderma Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.galderma.com
Description
Related Info

Learn more about this trial

Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

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