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Completed

NCT Number: NCT00687908

Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigational Site, Barrie, Ontario, Canada

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About this study

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Exclusion criteria

  • Female Subjects who are pregnant, nursing or planning a pregnancy during the study
  • Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

Treatment and study plan

Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel

Drug

Topical Gel to the face, once daily in the evening for 24 weeks.

Other names: Adapalene-BPO gel

Vehicle gel

Drug

Topical Gel to the face, once daily in the evening for 24 weeks.

Primary outcomes

  1. Maintenance Success for Total Lesions at Week 24

    Time frame: Week 24

    Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.

Secondary outcomes

  1. Maintenance Success for Inflamatory Lesions at Week 24

    Time frame: Week 24

    Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.

  2. Maintenance Success for Non-inflammatory Lesions at Week 24

    Time frame: Week 24

    Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.

  3. Investigator Global Assessment (IGA) Maintenance Success at Week 24

    Time frame: Baseline, Week 24

    IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.

    IGA grade:

    0 Clear:Residual hyperpigmentation & erythema may be present

    • Almost Clear:A few scattered comedones & a few small papules.
    • Mild:Some comedones & some papules and pustules. No nodules present
    • Moderate:Many comedones, papules & pustules. One nodule may be present
    • Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present
    • Very severe:Highly inflammatory acne covering the face; with nodules & cysts present

  4. Percent of Subjects With Adverse Events

    Time frame: Up to 24 weeks

    All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment

Acronym: ACCESS II

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 2, 2008
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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