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

NCT ID: NCT00441415

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Adapalene BPO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
3. 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.

Exclusion Criteria

1. Subjects with acne cystic lesions,
2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Principal Investigators

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Elisabeth ARTHUR, MD

Role:

Helendale Dermatology - Rochester NY - 585-266-5420

Alicia BUCKO, MD

Role:

Academic Dermatology Associates - Albuquerque NM - 505-247-4220

Paul YAMAUCHI, MD

Role:

Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887

Steven E. KEMPERS, MD

Role:

Minnesota Clinical Study Center - Fridley MN - 763-571-4200

Harald GOLLNICK, MD

Role: PRINCIPAL_INVESTIGATOR

Otto-von-Guericke University - Magdeburg - Germany

Yvonne FRAMBACH, MD

Role:

Universitatsklinikum - Lubeck - Germany

Michael MEURER, MD

Role:

Dresden University - Dresden - Germany

Christos ZOUBOULIS, MD

Role:

Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany

Roland KAUFMANN, MD

Role:

Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany

Thomas SCHWARZ, MD

Role:

Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany

Locations

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Paul YAMAUCHI

Santa Monica, California, United States

Site Status

Steven E. KEMPERS

Fridley, Minnesota, United States

Site Status

Dr Alicia BUCKO

Albuquerque, New Mexico, United States

Site Status

Elisabeth ARTHUR

Rochester, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.galderma.com/

Related Info

Other Identifiers

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RD.03.SPR.29058

Identifier Type: -

Identifier Source: org_study_id

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