Treatment of Moderate to Severe Facial Acne Vulgaris
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2008-11
- Completion
- 2008-12
Outcome
Mixed primary results
registry analysis (superiority or other test); Doxycycline 2.4 mg/kg/Day vs Placebo Comparator; p = 0.087; Mean Change from Baseline -0.92 (95% CI -1.5 to 27.3); Cochran-Mantel-Haenszel NCT00612573 ↗
registry analysis (superiority or other test); Doxycycline 0.6 mg/kg/Day vs Placebo Comparator; p = 0.779; Mean Change from Baseline -0.75 (95% CI -14.8 to 10.3); Cochran-Mantel-Haenszel NCT00612573 ↗
registry MEAN Doxycycline 2.4 mg/kg/Day: 14.0 (Standard Deviation 19.7) Lesions NCT00612573 ↗
registry MEAN Placebo Comparator: 7.3 (Standard Deviation 13.8) Lesions NCT00612573 ↗
registry analysis (superiority or other test); Doxycycline 2.4 mg/kg/Day vs Placebo Comparator; p = 0.039; Cochran-Mantel-Haenszel NCT00612573 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxycycline | Small molecule | 0.6 mg/kg | Oral |
| Subject | Doxycycline | Small molecule | 1.2 mg/kg | Oral |
| Subject | Doxycycline | Small molecule | 2.4 mg/kg | Oral |