Clinical trial NCT01426269: Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Official title: Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® Capsules Compared to Placebo After an Initial 12 Week Treatment Regimen With Oracea® and MetroGel® 1% in Adults With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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%.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Period 2: Number of Subjects Who Relapsed
timeFrame: Period 2 (40 weeks)
Secondary outcomes:
measure: Period 2: Investigator's Global Assessment Success
timeFrame: Period 2 (40 weeks)
measure: Period 2: Clinician's Erythema Assessment
timeFrame: Period 2 (40 Weeks)
measure: Period 2: Inflammatory Lesion Count
timeFrame: Period 2 (40 Weeks)
Other outcomes:
measure: Period 1: Tolerability (Scaling)
timeFrame: Period 1 (12 Weeks)
measure: Period 1: Tolerability (Stinging/Burning)
timeFrame: Period 1 (12 Weeks)
measure: Period 1: Tolerability (Dryness)
timeFrame: Period 1 (12 Weeks)
Locations:
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
city: Coral Gables
country: United States
facility: Dadeland Dermatology
state: Florida
city: Corbin
country: United States
facility: Melissa L. F. Knuckles M.D., P.S.C.
state: Kentucky
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Richmond
country: United States
facility: Melissa L. F. Knuckles M.D., P.S.C.
state: Kentucky
city: Hunt Valley
country: United States
facility: The Maryland Laser, Skin, and Vein Institute, LLC
state: Maryland
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Brooklyn
country: United States
facility: Hilary Baldwin
state: New York
city: Rochester
country: United States
facility: The Center for Dermatology at Linden Oaks
state: New York
city: Warren
country: United States
facility: Brodell Medical, Inc.
state: Ohio
city: Portland
country: United States
facility: Center for Dermatology and Laser Surgery
state: Oregon
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References: