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

Condition(s) targeted: Rosacea

Intervention: oral doxycycline and topical metronidazole (Drug); oral doxycycline (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Galderma Laboratories, L.P.

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

Overall contact:
Joseph Scarborough, Phone: 845-656-5682, Email: jscarborough@acmeresearch.net

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%.

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: Percentage of subjects who relapse during phase 2 of the study

Secondary outcome:

Change from baseline in inflammatory lesion counts

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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.

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.

Joseph Scarborough, Phone: 845-656-5682, Email: jscarborough@acmeresearch.net

ATS Clinical Research, Santa Monica, California 90404, United States; Recruiting
Erin Haight, RN, Phone: 310-828-2282, Email: erinresearch@shamban-md.com
Ava Shamban, MD, Principal Investigator

Dadeland Dermatology, Coral Gables, Florida 33134, United States; Recruiting
Andrea Dawkins, Phone: 305-567-3017, Email: dawkinsDAR@aol.com
David A Rodriguez, MD, Principal Investigator

Dermatology Specialists Research, Louisville, Kentucky 40202, United States; Recruiting
Misty Humphress, RN, Phone: 502-583-7546, Email: 02@dspresearch.com
Joseph Fowler, MD, Principal Investigator

Melissa L. F. Knuckles M.D., P.S.C., Richmond, Kentucky 40475, United States; Recruiting
Cathy Fugitt, Phone: 859-623-0064, Email: sknckls@bellsouth.net
Melissa Knuckles, MD, Principal Investigator

The Maryland Laser, Skin, and Vein Institute, LLC, Hunt Valley, Maryland 21030, United States; Recruiting
Cristi Myers, Phone: 410-666-3960, Email: cmyers@mdlsv.com
Robert A Weiss, MD, Principal Investigator

Grekin Skin Institute, Warren, Michigan 48088, United States; Recruiting
Claudia Attala, Phone: 586-759-5525, Email: cattala@comcast.com
Steven Grekin, DO, Principal Investigator

Hilary Baldwin, Brooklyn, New York 11201, United States; Recruiting
Hilary Baldwin, MD, Phone: 718-797-3340, Email: hilary.baldwin@downstate.edu
Hilary Baldwin, MD, Principal Investigator

The Center for Dermatology at Linden Oaks, Rochester, New York 14625, United States; Recruiting
Molly LaPorta, RN, Phone: 585-922-9770, Email: Molly.laporta@rochestergeneral.org
Brett Shulman, MD, Principal Investigator

Brodell Medical, Inc., Warren, Ohio 44483, United States; Recruiting
Sandra Treleven, BSMT, Phone: 330-393-4000, Email: sltreleven@aol.com
Robert Brodell, MD, Principal Investigator

Center for Dermatology and Laser Surgery, Portland, Oregon 97225, United States; Recruiting
Bryn McCarthy, RN, Phone: 503-297-3440, Email: bmccarthy@centerdermlaser.com
Mary Bobak, RN
Bernard Gasch, MD, Principal Investigator

Starting date: September 2011
Last updated: November 9, 2011