Status:
COMPLETED
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
Lead Sponsor:
CollaGenex Pharmaceuticals
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT00126399
Start Date
June 1 2004
End Date
April 1 2005
Last Update
August 19 2005
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