Skip to main content
OpenTrials
Completed

NCT Number: NCT00688064

Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Acne Vulgaris 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

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Adapalene BPO Gel associated with Doxycyline Hyclate

Drug

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

Vehicle Gel associated with Doxycycline Hyclate

Drug

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

Primary outcomes

  1. Percent Change From Baseline in Total Lesion Counts at Week 12.

    Time frame: Week 12

Secondary outcomes

  1. Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.

    Time frame: Week 12

  2. Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12

    Time frame: Week 12

  3. 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

  4. 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)

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 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.

Acronym: ACCESS I

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.

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.