Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

CollaGenex Pharmaceuticals91 enrolled

Overview

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%

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%

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Rosacea

Interventions

doxycyclineDRUG

COL-101, QD plus metronidazole

doxycyclineDRUG

40 mg with metronidazole QD

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (7)

Joel Schlessinger

Omaha, Nebraska, United States

James Del Rosso

Las Vegas, Nevada, United States

Angela Moore

Arlington, Texas, United States

William Abramovits

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change in total lesion count from Baseline at the study endpoint

Time frame: 16 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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