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Treatment of Moderate to Severe Facial Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00612573
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE February 11, 2008
Results First Submitted Date  ICMJE February 14, 2011
Results First Posted Date  ICMJE April 19, 2011
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE February 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2011)
  • Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population [ Time Frame: Week 12 ]
    IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.
  • Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population [ Time Frame: Baseline to Week 12 ]
    Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Primary efficacy variables will be both the IGA and the absolute change from baseline for inflammatory lesions count at Week 12. [ Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84 ]
Change History Complete list of historical versions of study NCT00612573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2011)
  • Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]
    Noninflammatory Lesion Count includes open and closed comedones.
  • Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]
    Total Lesion Count is the sum of inflammatory and noninflammatory lesions.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Secondary efficacy variables will be the percent change in inflammatory lesion count and the absolute change from baseline for non-inflammatory and total lesions count at Week 12. [ Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Moderate to Severe Facial Acne Vulgaris
Official Title  ICMJE Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris
Brief Summary Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Doxycycline 0.6 mg/kg/day
    doxycycline 40 mg/day, oral, 12 weeks
  • Drug: Doxycycline 1.2 mg/kg/day
    doxycycline 80 mg/day, 12 weeks
  • Drug: Doxycycline 2.4 mg/kg/day
    doxycycline 160 mg/day, 12 weeks
  • Drug: Placebo
    Placebo, 12 weeks
Study Arms  ICMJE
  • Experimental: Doxycyline 0.6 mg/kg/day
    Doxycycline dosed at 40 mg/day to subjects of appropriate weights
    Intervention: Drug: Doxycycline 0.6 mg/kg/day
  • Experimental: Doxycycline 1.2 mg/kg/day
    Doxycycline dosed at 80 mg/day to subjects of appropriate weights
    Intervention: Drug: Doxycycline 1.2 mg/kg/day
  • Experimental: Doxycycline 2.4 mg/kg/day
    Doxycycline dosed at 160 mg/day to subjects of appropriate weights
    Intervention: Drug: Doxycycline 2.4 mg/kg/day
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2009)
257
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
280
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be between 12 and 45 years of age.
  • Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

Exclusion Criteria:

  • Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
  • Has a history of pseudomembranous colitis or antibiotic-associated colitis.
  • Has a history of hepatitis or liver damage or renal impairment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00612573
Other Study ID Numbers  ICMJE PR-07907
WC2055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Angelo Secci, MD Warner Chilcott
PRS Account Warner Chilcott
Verification Date April 2013

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