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Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Adapalene BPO

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

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

Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.

Main inclusion criteria:

Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.

Main exclusion criteria:

Subjects with acne cystic lesions,
Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

Sites / Locations

Paul YAMAUCHI
Steven E. KEMPERS
Dr Alicia BUCKO
Elisabeth ARTHUR

Outcomes

Primary Outcome Measures

Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.

Secondary Outcome Measures

Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit

Global severity assessment at each post Baseline visit

Full Information

NCT ID

NCT00441415

First Posted

February 27, 2007

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT00441415

Brief Title

Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Official Title

Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Galderma R&D

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.

6. Conditions and Keywords

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

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

272 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Adapalene BPO

Primary Outcome Measure Information:

Title

Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.

Secondary Outcome Measure Information:

Title

Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit

Title

Global severity assessment at each post Baseline visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria. Main inclusion criteria: Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose. Main exclusion criteria: Subjects with acne cystic lesions, Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

Overall Study Officials: