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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
May 28, 2008
March 31, 2010
August 2008
February 2009   (Final data collection date for primary outcome measure)
Percent Change From Baseline in Total Lesion Counts at Week 12. [ Time Frame: Week 12 ]
Same as current
Complete list of historical versions of study NCT00688064 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. [ Time Frame: Week 12 ]
  • Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 [ Time Frame: 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
  • 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)
  • Percent change from Baseline in total lesion count at each intermediate visit, Percent change in inflammatory lesion count and in non-inflammatory lesion count at each post Baseline visit. [ Time Frame: Weeks 2, 4, 8 and 12 ]
  • Incidence of Adverse Events, Local tolerance worst-score post Baseline, Postinflammatory hyperpigmentation for subjects with phototypes IV to VI [ Time Frame: All along the study ]
  • Investigator Global Assessment at each post Baseline visit, Global Improvement from Baseline at week 12/early termination [ Time Frame: Weeks 2, 4, 8 and 12 ]
Not Provided
Not Provided
 
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
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.
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)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Severe Acne Vulgaris
  • 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
  • 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
  • Experimental: 1
    Adapalene-BPO + Doxycyline
    Intervention: Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
  • Active Comparator: 2
    Vehicle + Doxycycline
    Intervention: Drug: Vehicle Gel associated with Doxycycline Hyclate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
459
February 2009
February 2009   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
12 Years to 35 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   United States
 
 
NCT00688064
RD.03.SPR.29074
No
Not Provided
Not Provided
Not Provided
Jean-Charles DHUIN Clinical Trial Manager, Galderma
Galderma
Not Provided
Principal Investigator: Linda Stein Gold, MD Henry Ford Medical Center-New Center One, Detroit, MI
Galderma
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP