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

NCT00441415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-02-17

No results posted yet for this study

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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Adapalene BPO

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal 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

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441415 on ClinicalTrials.gov