A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea | NCT00126399 | Trialant
CompletedInterventionalPhase 3Updated Aug 19, 2005
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
ClinicalTrials.gov ID
NCT00126399
Lead Sponsor
CollaGenex PharmaceuticalsINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
528
Last Update Posted
Aug 19, 2005Estimated
Start Date
Jun 2004
Completion Date
Apr 2005
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.
Rosacea
doxycycline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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