Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo After 12 Weeks of Oracea® and MetroGel® 1% - Full Text View

Purpose

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%.

Condition	Intervention	Phase
Rosacea	Drug: oral doxycycline and topical metronidazole Drug: oral doxycycline Drug: placebo	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Metronidazole Doxycycline Metronidazole benzoate Doxycycline monohydrate Doxycycline Hyclate Metronidazole hydrochloride Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Percentage of subjects who relapse during phase 2 of the study [ Time Frame: Phase 2 (week 12 - week 52) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in inflammatory lesion counts [ Time Frame: Baseline - week 52 ] [ Designated as safety issue: No ]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline - week 52 ] [ Designated as safety issue: Yes ]
Number of participants with adverse events in each treatment arm.

Estimated Enrollment:	200
Study Start Date:	September 2011
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Subjects will receive placebo during phase 2 (week 12 - week 52)	Drug: placebo During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning Other Name: Placebo
Oracea® and MetroGel® 1% Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)	Drug: oral doxycycline and topical metronidazole 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 and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
Active Comparator: Oracea® Capsules Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)	Drug: oral doxycycline During 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 Other Name: Oracea

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426269

Locations

United States, California
ATS Clinical Research
Santa Monica, California, United States, 90404
United States, Florida
Dadeland Dermatology
Coral Gables, Florida, United States, 33134
United States, Kentucky
Melissa L. F. Knuckles M.D., P.S.C.
Corbin, Kentucky, United States, 40701
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
Melissa L. F. Knuckles M.D., P.S.C.
Richmond, Kentucky, United States, 40475
United States, Maryland
The Maryland Laser, Skin, and Vein Institute, LLC
Hunt Valley, Maryland, United States, 21030
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, New York
Hilary Baldwin
Brooklyn, New York, United States, 11201
The Center for Dermatology at Linden Oaks
Rochester, New York, United States, 14625
United States, Ohio
Brodell Medical, Inc.
Warren, Ohio, United States, 44483
United States, Oregon
Center for Dermatology and Laser Surgery
Portland, Oregon, United States, 97225

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT01426269 History of Changes
Other Study ID Numbers:	US10183
Study First Received:	August 26, 2011
Last Updated:	June 25, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Doxycycline
Doxycycline hyclate
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013