Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
Information source: CollaGenex Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: doxycycline (Drug); metronidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: CollaGenex Pharmaceuticals
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%
Clinical Details
Official title: A Clinical Trial to 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 With Moderate to Severe Rosacea
Study design: Supportive Care, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in total lesion count from Baseline at the study endpoint
Secondary outcome: Change in Investigator’s Global Assessment from Baseline at the study endpointChange in Clinician’s Erythema Assessment score from Baseline at the study endpoint Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Joel Schlessinger, Omaha, Nebraska 68144, United States; Recruiting
Rhonda Jansen, Phone: 402-334-7546, Email: skindoc@lovelyskin.com
James Del Rosso, Las Vegas, Nevada 89052, United States; Recruiting
Anna M Sanglay, Phone: 702-990-4800, Email: doctorskin777@yahoo.com
Angela Moore, Arlington, Texas 76011, United States; Recruiting
Debbie Slay, Phone: 817-795-7546, Email: acdermatology@yahoo.com
William Abramovits, Dallas, Texas 75230, United States; Recruiting
Angela Tolman, Phone: 972-661-2729, Email: angelat@dermcenter.us
Douglas Forsha, West Jordan, Utah 84088, United States; Recruiting
Lisa Davis, Phone: 801-569-1456, Email: ldavis@southvalleyderm.com
Bernard Goffe, Seattle, Washington 98101, United States; Recruiting
Nick Vadan, Phone: 206-267-2100, Email: nvadan@daseattle.com
William Werschler, Spokane, Washington 99204, United States; Recruiting
Camilla Alexander, Phone: 509-879-3530, Email: calexander54@msn.com
Additional Information
Starting date: March 2007
Ending date: November 2007
Last updated: June 29, 2007
|
