A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

PHASE3CompletedINTERVENTIONAL
Enrollment

1,009

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Rosacea
Interventions
DRUG

Azelaic acid

Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

DRUG

Vehicle

Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

DRUG

Finacea

Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Trial Locations (30)

Unknown

Site 24, Fremont

Site 22, Santa Monica

Site 1, Brandon

Site 3, Fort Myers

Site 27, Jacksonville

Site 19, Miami

Site 9, Miami

Site 29, Miramar

Site 2, Tampa

Site 15, Chicago

Site 4, Plainfield

Site 14, Lake Charles

Site 17, Glenn Dale

Site 6, Bay City

Site 30, Clinton Township

Site 16, Las Vegas

Site 11, Raleigh

Site 23, Winston-Salem

Site 26, Philadelphia

Site 12, Warwick

Site 28, Simpsonville

Site 20, Nashville

Site 21, College Station

Site 5, Dallas

Site 8, El Paso

Site 13, Houston

Site 7, Katy

Site 18, Salt Lake City

Site 10, Norfolk

Site 25, University Place

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actavis Inc.

INDUSTRY

NCT02120924 - A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea | Biotech Hunter | Biotech Hunter