A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea

PHASE3CompletedINTERVENTIONAL
Enrollment

924

Participants

Timeline

Start Date

July 19, 2016

Primary Completion Date

June 22, 2017

Study Completion Date

June 22, 2017

Conditions
Rosacea
Interventions
DRUG

Generic Azelaic Acid Foam

Topical foam, generic formulation of the brand product.

DRUG

Finacea® (Azelaic Acid) Foam

Topical foam, brand product.

DRUG

Vehicle Foam

Topical foam, placebo. Has no active ingredient.

OTHER

Cleanser

A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.

OTHER

Sunscreen

Sunscreen provided to participants, so they can apply it to their face when outdoors.

OTHER

Towel

A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.

OTHER

Moisturizing Lotion

Moisturizing lotion provided to participants, so they can apply it to their face, as needed.

Trial Locations (26)

Unknown

Investigative Site 2, Encino

Investigative Site 10, La Mesa

Investigative Site 19, Brandon

Investigative Site 1, Hialeah

Investigative Site 9, Hialeah

Investigative Site 23, Lauderdale Lakes

Investigative Site 11, Miami

Investigative Site 15, Miami

Investigative Site 20, Miami

Investigative Site 12, Miramar

Investigative Site 25, Ocala

Investigative Site 22, Pembroke Pines

Investigative Site 18, Tampa

Investigative Site 16, Savannah

Investigative Site 14, Plainfield

Investigative Site 13, Wichita

Investigative Site 6, New Orleans

Investigative Site 17, Omaha

Investigative Site 8, High Point

Investigative Site 3, Cincinnati

Investigative Site 21, Philadelphia

Investigative Site 4, Dallas

Investigative Site 26, El Paso

Investigative Site 7, New Braunfels

Investigative Site 5, Norfolk

Investigative Site 24, Spokane

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actavis Inc.

INDUSTRY

NCT03287791 - A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea | Biotech Hunter | Biotech Hunter