A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis

PHASE3CompletedINTERVENTIONAL
Enrollment

441

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

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 (22)

10003

Union Square Dermatology, New York

23507

Virginia Clinical Research, Norfolk

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

27262

Dermatology Consulting Services, High Point

29607

Greenville Dermatology, LLC, Greenville

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

33609

Moore Clinical Research, Inc., Tampa

37917

Dermatology Associates of Knoxville, PC, Knoxville

46032

Shideler Clinical Research Center, Carmel

46168

The Indiana Clinical Trials Center, Plainfield

46256

Dawes Fretzin Clinical Research Group, LLC, Indianapolis

60005

Altman Dermatology Associates, Arlington Heights

61820

Christie Clinic, LLC, Champaign

77056

The Center for Skin Research, Houston

78759

DermResearch, Inc.Austin, Austin

83704

Northwest Clinical Trials, Inc., Boise

89074

Bettencourt Skin Center, Henderson

92120

SD Sports Medicine & Family Health Center, San Diego

94538

Center for Dermatology Clinical Research, Inc, Fremont

02886

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actavis Inc.

INDUSTRY

NCT02654769 - A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis | Biotech Hunter | Biotech Hunter