Treatment of Moderate to Severe Facial Acne Vulgaris

• 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: Warner Chilcott
• Information provided by (Responsible Party): Warner Chilcott

Tracking Information

• First Submitted Date: January 25, 2008
• First Posted Date: February 11, 2008
• Results First Submitted Date: February 14, 2011
• Results First Posted Date: April 19, 2011
• Last Update Posted Date: April 22, 2013
• Study Start Date: February 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2009): 257
• Original Estimated Enrollment (submitted: January 25, 2008): 280
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 12 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00612573
• Other Study ID Numbers: PR-07907; WC2055
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Warner Chilcott
• Study Sponsor: Warner Chilcott
• Collaborators: Not Provided

Investigators

• Study Director: Angelo Secci, MD; Warner Chilcott

• PRS Account: Warner Chilcott
• Verification Date: April 2013