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

PHASE4CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Rosacea
Interventions
DRUG

Doxycycline

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

DRUG

Metronidazole

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

DRUG

Placebo

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

Trial Locations (11)

11201

Hilary Baldwin, Brooklyn

14625

The Center for Dermatology at Linden Oaks, Rochester

21030

The Maryland Laser, Skin, and Vein Institute, LLC, Hunt Valley

33134

Dadeland Dermatology, Coral Gables

40202

Dermatology Specialists Research, Louisville

40475

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

40701

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

44483

Brodell Medical, Inc., Warren

48088

Grekin Skin Institute, Warren

90404

ATS Clinical Research, Santa Monica

97225

Center for Dermatology and Laser Surgery, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Galderma R&D

INDUSTRY

NCT01426269 - Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo | Biotech Hunter | Biotech Hunter