NCT00612573

Treatment of Moderate to Severe Facial Acne Vulgaris

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-02-11
• Last updated: 2013-04-22
• Results posted: 2011-04-19

Locations

23 sites across 1 country: United States