An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis

PHASE3CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

August 19, 2016

Primary Completion Date

March 7, 2017

Study Completion Date

March 22, 2017

Conditions
ACTINIC KERATOSIS
Interventions
DRUG

Ingenol Mebutate (Picato®)

Brand product

DRUG

Generic Ingenol Mebutate

Generic formulated to have the same therapeutic effect of the brand

DRUG

Vehicle Foam

It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Trial Locations (23)

27262

Dermatology Consulting Services, High Point

29644

Palmetto Clinical Trial Services, Fountain Inn

30263

MedaPhase, Inc., Newnan

33014

Savin Medical Group Research Center, Miami Lakes

33162

Tory P. Sullivan, M.D., P.A., North Miami Beach

33180

The Center for Clinical and Cosmetic Research, Aventura

33511

Moore Clinical Research, Brandon

37917

Dermatology Associates of Knoxville, PC, Knoxville

46032

Forefront Dermatology, Carmel

46168

The Indiana Clinical Trials Center, Plainfield

46256

Dawes Fretzin Clinical Research Group, LLC, Indianapolis

46617

The South Bend Clinic,LLC, South Bend

55432

Minnesota Clinical Study Center, Fridley

60005

Arlington Dermatology, Arlington Heights

60561

University Dermatology & Vein Clinic, LLC, Darien

61820

Christie Clinic, LLC, Champaign

64506

MediSearch Clinical Trials, Saint Joseph

78130

DermReseach New Braunfels, New Braunfels

80220

Horizons Clinical Research Ctr., LLC, Denver

83704

Northwest Clinical Trials, Inc., Boise

87106

Academic Dermatology Associates, Albuquerque

92056

Dermatology Specialists, Inc., Oceanside

02886

Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actavis Inc.

INDUSTRY

NCT03200912 - An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis | Biotech Hunter | Biotech Hunter