Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
Information source: CollaGenex Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: doxycycline (Drug); doxycycline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: CollaGenex Pharmaceuticals Official(s) and/or principal investigator(s): Christopher V Powala, JD, Study Chair, Affiliation: 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: 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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
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%
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
James Del Rosso, Las Vegas, Nevada 89052, United States
Angela Moore, Arlington, Texas 76011, United States
William Abramovits, Dallas, Texas 75230, United States
Douglas Forsha, West Jordan, Utah 84088, United States
Bernard Goffe, Seattle, Washington 98101, United States
William Werschler, Spokane, Washington 99204, United States
Additional Information
Starting date: March 2007
Last updated: December 11, 2008
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