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

February 16, 2021 updated by: Galderma R&D

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada
        • Galderma Investigational Site
      • North Bay, Ontario, Canada
        • Galderma Investigational Site
      • Windsor, Ontario, Canada
        • Galderma Investigational Site
    • Quebec
      • Quebec city, Quebec, Canada
        • Galderma Investigational Site
  • Puerto Rico
      • Aibonito, Puerto Rico
        • Galderma Investigational Site
      • Carolina, Puerto Rico
        • Galderma Investigational Site
  • United States
    • California
      • Oceanside, California, United States
        • Galderma Investigational Site
      • San Diego, California, United States
        • Galderma Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Galderma Investigational Site
      • Longmont, Colorado, United States
        • Galderma Investigational Site
    • Florida
      • Miami, Florida, United States
        • Galderma Investigational Site
    • Georgia
      • Snellville, Georgia, United States
        • Galderma Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Galderma Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • Galderma Investigational Site
    • Kansas
      • Overland Park, Kansas, United States
        • Galderma Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Galderma Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • Galderma Investigational Site
      • Fort Gratiot, Michigan, United States
        • Galderma Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States
        • Galderma Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Galderma Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Galderma Investigational Site
    • New York
      • Stony Brook, New York, United States
        • Galderma Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Galderma Investigational Site
    • Ohio
      • Warren, Ohio, United States
        • Galderma Investigational Site
    • Pennsylvania
      • Hazleton, Pennsylvania, United States
        • Galderma Investigational Site
      • Hershey, Pennsylvania, United States
        • Galderma Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, United States
        • Galderma Investigational Site
    • Texas
      • 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
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Vehicle gel + Doxycycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Total Lesion Counts at Week 12.
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
Time Frame: Week 12
Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Time Frame: Week 12
Week 12
Success Rate on the Investigator's Global Assessment
Time Frame: Week 12
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
Week 12
Percent of Subjects With Adverse Events
Time Frame: Up to 12 weeks
Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Linda Stein Gold, MD, Henry Ford Medical Center-New Center One, Detroit, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (ESTIMATE)

June 2, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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