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

Sponsor

Galderma R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT00441415

Collaborator

(none)

272

Enrollment

Locations

Duration (Months)

Patients Per Site

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene BPO	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

272 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paul YAMAUCHI	Santa Monica	California	United States	90404
2	Steven E. KEMPERS	Fridley	Minnesota	United States	55432
3	Dr Alicia BUCKO	Albuquerque	New Mexico	United States	87106
4	Elisabeth ARTHUR	Rochester	New York	United States	14609

Sponsors and Collaborators

Galderma R&D

Investigators

: Elisabeth ARTHUR, MD, Helendale Dermatology - Rochester NY - 585-266-5420
: Alicia BUCKO, MD, Academic Dermatology Associates - Albuquerque NM - 505-247-4220
: Paul YAMAUCHI, MD, Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
: Steven E. KEMPERS, MD, Minnesota Clinical Study Center - Fridley MN - 763-571-4200
Principal Investigator: Harald GOLLNICK, MD, Otto-von-Guericke University - Magdeburg - Germany
: Yvonne FRAMBACH, MD, Universitatsklinikum - Lubeck - Germany
: Michael MEURER, MD, Dresden University - Dresden - Germany
: Christos ZOUBOULIS, MD, Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany
: Roland KAUFMANN, MD, Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany
: Thomas SCHWARZ, MD, Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00441415

Other Study ID Numbers:

RD.03.SPR.29058

First Posted:

Feb 28, 2007

Last Update Posted:

Feb 17, 2021

Last Verified:

Aug 1, 2008

Additional relevant MeSH terms:

Acne Vulgaris

Adapalene

Study Results

No Results Posted as of Feb 17, 2021