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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014