A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CollaGenex Pharmaceuticals
• Treatments: Doxycycline

Criteria

Main Inclusion Criteria:

• Healthy patients with rosacea

• Males and females ≥18 years of age

• 10 to 40 papules and pustules and ≤2 nodules

• Score of 2 to 4 on the IGA

• Presence of telangiectasia

• Moderate to severe erythema

Main Exclusion Criteria:

• Use of topical acne treatments or topical or systemic antibiotics

• Use of systemic retinoids within 90 days of baseline

• Use of an investigational drug within 90 days of baseline

• Pregnant or nursing women

• Women of childbearing potential not using an adequate form of contraception

• Change in method of contraception within 4 months of baseline

• Known hypersensitivity to tetracyclines

• Surgeries that bypass or exclude the duodenum or achlorhydria