NCT00635609

Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Detailed description

Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Doxycycline hyclate (Doryx)	150mg/day, oral, delayed release tablets
DRUG	Doxycycline hyclate	100 mg/day, oral, tablets, immediate release

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-03-14
• Last updated: 2012-04-20
• Results posted: 2009-12-30

Locations

4 sites across 1 country: United States