A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

PHASE3CompletedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Actinic Keratosis
Interventions
PROCEDURE

Cryotherapy

"Cryotherapy of all visible AKs (4-8 lesions, baseline lesions) in the selected treatment area"

DRUG

Vehicle

Field treatment with vehicle gel once daily for 3 consecutive days.

DRUG

Ingenol metabute

Field treatment with vehicle gel once daily for 3 consecutive days.

Trial Locations (35)

10029

Mount Sinai School of Medicine, New York

11787

Long Island Skin Cancer and Dermatologic Surgery, Smithtown

14623

Skin Search of Rochester, Inc., Rochester

19034

Philadelphia Institute of Dermatology, Fort Washington

23507

Virginia Clinical Research, Inc., Norfolk

24501

The Education & Research Foundation, Inc., Lynchburg

30078

Gwinnett Clinical Research Center, Inc., Snellville

30263

MedaPhase, Newnan

32204

North Florida Dermatology Associates, PA, Jacksonville

33180

The Center for Clincial and Cosmetic Research, Aventura

33437

Study Protocol, Inc., Boynton Beach

33612

University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare, Tampa

37203

Dermatology Research Associates, Inc., Nashville

46032

Laser & Skin Surgery Center of Indiana, Carmel

46168

The Indiana Clinical Trials Center, PC, Plainfield

48088

Grekin Skin Institute, Warren

48202

Henry Ford Medical Centre - New Center One, Department of Dermatology, Detroit

48706

Great Lakes Research Center, Bay City

55432

Minnesota Clinical Study Center, Fridley

60005

Altman Dermatology Associates, Arlington Heights

76011

Arlington Research Center, Inc., Arlington

77056

Suzanne Bruce and Associates, P.A., Houston

77598

Center for Clinical Studies, Webster

78229

Dermatology Clinical Research Center of San Antonio, San Antonio

80113

About Skin Dermatology and DermSurgery, PC, Englewood

80210

Colorado Medical Research Center, Inc., Denver

84117

Dermatology Research Center, Inc., Salt Lake City

87106

Academic Dermatology Associates, Albuquerque

92056

Dermatology Specialists, Inc., Oceanside

92117

Skin Surgery Medical Group, Inc., San Diego

92123

University Clinical Trials, Inc., San Diego

94538

Center for Dermatology Clinical Research, Fremont

97223

Oregon Medical Research Center, PC, Portland

99204

Premier Clinical Research, Spokane

97239-6483

Oregon Health & Science University, Dept. of Dermatology, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LEO Pharma

INDUSTRY