Clinical Trial: Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients Wit
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 Summary: 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%
Sponsor: CollaGenex Pharmaceuticals
Current Primary Outcome: Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Investigator's Global Assessment from Baseline at the study endpoint [ Time Frame: 16 weeks ]
- Change in Clinician's Erythema Assessment score from Baseline at the study endpoint [ Time Frame: 16 weeks ]
- Change in total lesion count (papules + pustules + nodules) from Baseline at each visit [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
Original Secondary Outcome: Same as current
Information By: CollaGenex Pharmaceuticals
Dates:
Date Received: June 29, 2007
Date Started: March 2007
Date Completion:
Last Updated: December 11, 2008
Last Verified: December 2008
