Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
- Registration Number
- NCT00495313
- Lead Sponsor
- CollaGenex Pharmaceuticals
- Brief Summary
To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
- Detailed Description
Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
- 8-40 total lesions
- erythema
- telangiectasia
Exclusion Criteria
- non-pregnant, non-lactating
- achlorhydric
- gastric by-pass surgery
- allergy to study medications
- drug/alcohol abuse
- use of proton pump inhibitors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: doxycycline doxycycline Vibramycin plus metronidazole Cohort 2 doxycycline Oracea® delayed release plus metronidazole
- Primary Outcome Measures
Name Time Method Change in total lesion count from Baseline at the study endpoint 16 weeks
- Secondary Outcome Measures
Name Time Method Change in Investigator's Global Assessment from Baseline at the study endpoint 16 weeks Change in Clinician's Erythema Assessment score from Baseline at the study endpoint 16 weeks Change in total lesion count (papules + pustules + nodules) from Baseline at each visit 4 weeks, 8 weeks, 12 weeks
Trial Locations
- Locations (7)
Douglas Forsha
🇺🇸West Jordan, Utah, United States
Angela Moore
🇺🇸Arlington, Texas, United States
Bernard Goffe
🇺🇸Seattle, Washington, United States
William Werschler
🇺🇸Spokane, Washington, United States
James Del Rosso
🇺🇸Las Vegas, Nevada, United States
Joel Schlessinger
🇺🇸Omaha, Nebraska, United States
William Abramovits
🇺🇸Dallas, Texas, United States