Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo

Galderma R&D235 enrolled

Overview

The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.

Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

235

Conditions

Rosacea

Interventions

DoxycyclineDRUG

During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release \& 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release \& 10 mg delayed release beads), oral, one capsule daily in the morning

MetronidazoleDRUG

During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area

PlaceboDRUG

During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is male or female aged 18 to 80 years inclusive. * Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of moderate or severe. * For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry. Exclusion Criteria: * Female subjects who are pregnant, nursing or planning a pregnancy during the study. * Subject has any other active dermatological condition on the face that may interfere with the conduct of the study. * Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications. * Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.

Locations (11)

ATS Clinical Research

Santa Monica, California, United States

Dadeland Dermatology

Coral Gables, Florida, United States

Melissa L. F. Knuckles M.D., P.S.C.

Corbin, Kentucky, United States

Outcomes

Primary Outcomes

Period 2: Number of Subjects Who Relapsed

Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria: * A return to the baseline lesion count * A return to the baseline IGA score * The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm.

Time frame: Period 2 (40 weeks)

Secondary Outcomes

Period 2: Investigator's Global Assessment Success

The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).

Time frame: Period 2 (40 weeks)

Period 2: Clinician's Erythema Assessment

The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.

Time frame: Period 2 (40 Weeks)

Period 2: Inflammatory Lesion Count

The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.

Time frame: Period 2 (40 Weeks)

Data from ClinicalTrials.gov

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