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
Overview
- Phase
- Phase 2
- Intervention
- Doxycycline 0.6 mg/kg/day
- Conditions
- Acne Vulgaris
- Sponsor
- Warner Chilcott
- Enrollment
- 257
- Locations
- 1
- Primary Endpoint
- Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Doxycyline 0.6 mg/kg/day
Doxycycline dosed at 40 mg/day to subjects of appropriate weights
Intervention: Doxycycline 0.6 mg/kg/day
Doxycycline 1.2 mg/kg/day
Doxycycline dosed at 80 mg/day to subjects of appropriate weights
Intervention: Doxycycline 1.2 mg/kg/day
Doxycycline 2.4 mg/kg/day
Doxycycline dosed at 160 mg/day to subjects of appropriate weights
Intervention: Doxycycline 2.4 mg/kg/day
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population(Baseline to Week 12)
- Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population(Baseline to Week 12)