Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris (ACCESS I)

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00688064
First received: May 28, 2008
Last updated: March 31, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.


Condition Intervention Phase
Severe Acne Vulgaris
Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
Drug: Vehicle Gel associated with Doxycycline Hyclate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Percent Change From Baseline in Total Lesion Counts at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Success Rate on the Investigator's Global Assessment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12

  • Percent of Subjects With Adverse Events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)


Enrollment: 459
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Adapalene-BPO + Doxycyline
Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Other Name: Adapalene-BPO gel + Doxycycline
Active Comparator: 2
Vehicle + Doxycycline
Drug: Vehicle Gel associated with Doxycycline Hyclate
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Other Name: Vehicle gel + Doxycycline

Detailed Description:

Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female Subjects of any race, aged 12 to 35 years inclusive
  • Subjects with severe facial acne (global severity score of 4)
  • Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
  • Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

  • Subjects with more than 3 nodules or cysts on the face,
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688064

  Hide Study Locations
Locations
United States, California
Galderma Investigational Site
Oceanside, California, United States
Galderma Investigational Site
San Diego, California, United States
United States, Colorado
Galderma Investigational Site
Denver, Colorado, United States
Galderma Investigational Site
Longmont, Colorado, United States
United States, Florida
Galderma Investigational Site
Miami, Florida, United States
United States, Georgia
Galderma Investigational Site
Snellville, Georgia, United States
United States, Illinois
Galderma Investigational Site
Chicago, Illinois, United States
United States, Indiana
Galderma Investigational Site
Evansville, Indiana, United States
United States, Kansas
Galderma Investigational Site
Overland Park, Kansas, United States
United States, Kentucky
Galderma Investigational Site
Louisville, Kentucky, United States
United States, Michigan
Galderma Investigational Site
Detroit, Michigan, United States
Galderma Investigational Site
Fort Gratiot, Michigan, United States
United States, Minnesota
Galderma Investigational Site
Fridley, Minnesota, United States
United States, Nebraska
Galderma Investigational Site
Omaha, Nebraska, United States
United States, New Mexico
Galderma Investigational Site
Albuquerque, New Mexico, United States
United States, New York
Galderma Investigational Site
Stony Brook, New York, United States
United States, North Carolina
Galderma Investigational Site
Winston Salem, North Carolina, United States
United States, Ohio
Galderma Investigational Site
Warren, Ohio, United States
United States, Pennsylvania
Galderma Investigational Site
Hazleton, Pennsylvania, United States
Galderma Investigational Site
Hershey, Pennsylvania, United States
United States, South Carolina
Galderma Investigational Site
Simpsonville, South Carolina, United States
United States, Texas
Galderma Investigational Site
Arlington, Texas, United States
Galderma Investigational Site
Austin, Texas, United States
Galderma Investigational Site
College Station, Texas, United States
Galderma Investigational Site
Houston, Texas, United States
Galderma Investigational Site
Lubbock, Texas, United States
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
Webster, Texas, United States, 77598
Canada, Ontario
Galderma Investigational Site
Barrie, Ontario, Canada
Galderma Investigational Site
North Bay, Ontario, Canada
Galderma Investigational Site
Windsor, Ontario, Canada
Canada, Quebec
Galderma Investigational Site
Quebec city, Quebec, Canada
Puerto Rico
Galderma Investigational Site
Aibonito, Puerto Rico
Galderma Investigational Site
Carolina, Puerto Rico
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Linda Stein Gold, MD Henry Ford Medical Center-New Center One, Detroit, MI
  More Information

Additional Information:
No publications provided

Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00688064     History of Changes
Other Study ID Numbers: RD.03.SPR.29074
Study First Received: May 28, 2008
Results First Received: February 23, 2010
Last Updated: March 31, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Galderma:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Doxycycline
Doxycycline hyclate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
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 April 17, 2014