Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance

Phase 3

Completed

• Conditions: Acne
• Interventions: Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel; Drug: Vehicle Gel

• Registration Number: NCT00687908
• Lead Sponsor: Galderma R&D

Brief Summary

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Detailed Description

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Study Timeline

• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Study Start: 2008-11
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2010-07-16
• Results First Submitted QC: 2010-08-26
• Status Verified: 2010-09
• Results First Posted: 2010-09-24
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning a pregnancy during the study
• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
2	Vehicle Gel	Vehicle Gel once daily

Primary Outcome Measures

Name	Time	Method
Maintenance Success for Total Lesions at Week 24	Week 24	Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.

Secondary Outcome Measures

Name	Time	Method
Maintenance Success for Non-inflammatory Lesions at Week 24	Week 24	Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.
Investigator Global Assessment (IGA) Maintenance Success at Week 24	Baseline, Week 24	IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.; IGA grade: 0 Clear:Residual hyperpigmentation \& erythema may be present; 1. Almost Clear:A few scattered comedones \& a few small papules.; 2. Mild:Some comedones \& some papules and pustules. No nodules present; 3. Moderate:Many comedones, papules \& pustules. One nodule may be present; 4. Severe:Covered with comedones, numerous papules \& pustules \& few nodules \& cysts may be present; 5. Very severe:Highly inflammatory acne covering the face; with nodules \& cysts present
Percent of Subjects With Adverse Events	Up to 24 weeks	All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Maintenance Success for Inflamatory Lesions at Week 24	Week 24	Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.

Trial Locations

Locations (1)

Galderma Investigational Site; 🇵🇷 Carolina, Puerto Rico