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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: doxycycline
  • doxycycline 40 mg/day, oral
• Drug: doxycycline
  • doxycycline 80 mg/day
• Drug: doxycycline
  • doxycycline 160 mg/day
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Placebo Comparator: 4

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    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 Sponsor: Warner Chilcott

Overall Clinical Trial Officials and Contacts

Angelo Secci, MD Study Director Warner Chilcott  

Information obtained from ClinicalTrials.gov on September 05, 2008

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