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A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00421993
First received: January 11, 2007
Last updated: October 19, 2009
Last verified: October 2009
History of Changes
  Purpose

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Condition Intervention Phase
Acne Vulgaris
 Drug: Adapalene/Benzoyl Peroxide
Drug: Adapalene
Drug: Benzoyl Peroxide
Drug: Topical Gel Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • Success Rate on the Investigator's Global Assessment [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Changes in Inflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
  • Changes in Noninflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change in Inflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Percent Change in Noniflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Percent Change in Total Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Enrollment: 1670
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Adapalene/Benzoyl Peroxide Topical Gel
 Drug: Adapalene/Benzoyl Peroxide
Topical Gel, One application daily in the evening for 12 weeks
Active Comparator: 2
Adapalene Topical Gel
 Drug: Adapalene
Topical Gel,One application daily in the evening for 12 weeks
Active Comparator: 3
Benzoyl Peroxide Topical Gel
 Drug: Benzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
Placebo Comparator: 4
Topical Gel Vehicle
 Drug: Topical Gel Vehicle
Topical Gel Vehicle,one application daily in the evening for 12 weeks

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 Inflammatory lesions
  • A minimum of 30 but not more than 100 Noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

  • More than one acne nodule or any acne cyst.
  • Acne conglobata, acne fulminans, secondary acne, or severe acne.
  • Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
  • Underlying diseases that require the use of interfering topical or systemic therapy.
  • Use of prohibited medications prior to the study unless appropriate washout period is documented
  • Use of hormonal contraceptives solely for control of acne
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421993

  Show 62 Study Locations
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Michael Graeber, MD, Head of US Development, Galderma
ClinicalTrials.gov Identifier: NCT00421993     History of Changes
Other Study ID Numbers: RD.06.SPR.18088
Study First Received: January 11, 2007
Results First Received: January 15, 2009
Last Updated: October 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Acne vulgaris
Adapalene
Benzoyl Peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013