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

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ClinicalTrials.gov Identifier: NCT00688064
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : March 31, 2010
Last Update Posted : April 6, 2010
Sponsor:
Information provided by:
Galderma

Brief Summary:
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 or disease Intervention/treatment Phase
Severe Acne Vulgaris Drug: Adapalene BPO Gel associated with Doxycyline Hyclate Drug: Vehicle Gel associated with Doxycycline Hyclate Phase 3

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  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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 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




Primary Outcome Measures :
  1. Percent Change From Baseline in Total Lesion Counts at Week 12. [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688064


  Show 34 Study Locations
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Linda Stein Gold, MD Henry Ford Medical Center-New Center One, Detroit, MI

Additional Information:
Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00688064     History of Changes
Other Study ID Numbers: RD.03.SPR.29074
First Posted: June 2, 2008    Key Record Dates
Results First Posted: March 31, 2010
Last Update Posted: April 6, 2010
Last Verified: March 2010

Keywords provided by Galderma:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Benzoyl Peroxide
Adapalene
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic 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