Phase 2
N=257
Treatment of Moderate to Severe Facial Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00612573 ↗Enrolled (actual)
257
Serious AEs
0.4%
Results posted
Apr 2011
Primary outcome: Primary: Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population — 14.1; 15.4; 29.5; 16.4 Percentage of Participants — p=0.779
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxycycline 0.6 mg/kg/day (Drug); Doxycycline 1.2 mg/kg/day (Drug); Doxycycline 2.4 mg/kg/day (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Warner Chilcott
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population |
14.1; 15.4; 29.5; 16.4 | 0.779 |
| PRIMARY Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population |
8.1; 11.5; 14.0; 7.3 | 0.807 |
| SECONDARY Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population |
8.5; 5.2; 6.5; 1.8 | 0.212 |
| SECONDARY Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population |
16.6; 16.8; 20.5; 9.1 | 0.276 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00612573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.