A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
Phase 3
Completed
- Conditions
- Rosacea
- Registration Number
- NCT00126399
- Lead Sponsor
- CollaGenex Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 528
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in total inflammatory lesion count
- Secondary Outcome Measures
Name Time Method Change from baseline in erythema scale scores change from baseline in the investigator's global assessment (IGA) score proportion of patients being clear or near-clear at endpoint