Treatment of Moderate to Severe Facial Acne Vulgaris

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Doxycyline 0.6 mg/kg/day
  • Doxycycline dosed at 40 mg/day to subjects of appropriate weights
• Experimental: Doxycycline 1.2 mg/kg/day
  • Doxycycline dosed at 80 mg/day to subjects of appropriate weights
• Experimental: Doxycycline 2.4 mg/kg/day
  • Doxycycline dosed at 160 mg/day to subjects of appropriate weights
• Placebo Comparator: Placebo

Primary Measures

• Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
  • Time Frame: Week 12
    Safety Issue?: No
• Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

Secondary Measures

• Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Angelo Secci, MD Study Director Warner Chilcott  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612573

Study ID Number: PR-07907

ClinicalTrials.gov Identifier: NCT00612573

Health Authority: United States: Food and Drug Administration