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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 endpoint

Change 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

Page last updated: August 23, 2015

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