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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rosacea

Intervention: Doxycycline (Drug); Metronidazole (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.


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%.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Period 2: Number of Subjects Who Relapsed

Secondary outcome:

Period 2: Investigator's Global Assessment Success

Period 2: Clinician's Erythema Assessment

Period 2: Inflammatory Lesion Count

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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 and Contacts

ATS Clinical Research, Santa Monica, California 90404, United States

Dadeland Dermatology, Coral Gables, Florida 33134, United States

Melissa L. F. Knuckles M.D., P.S.C., Corbin, Kentucky 40701, United States

Dermatology Specialists Research, Louisville, Kentucky 40202, United States

Melissa L. F. Knuckles M.D., P.S.C., Richmond, Kentucky 40475, United States

The Maryland Laser, Skin, and Vein Institute, LLC, Hunt Valley, Maryland 21030, United States

Grekin Skin Institute, Warren, Michigan 48088, United States

Hilary Baldwin, Brooklyn, New York 11201, United States

The Center for Dermatology at Linden Oaks, Rochester, New York 14625, United States

Brodell Medical, Inc., Warren, Ohio 44483, United States

Center for Dermatology and Laser Surgery, Portland, Oregon 97225, United States

Additional Information

Starting date: September 2011
Last updated: July 8, 2014

Page last updated: August 23, 2015

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