A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

PHASE3TerminatedINTERVENTIONAL
Enrollment

563

Participants

Timeline

Start Date

June 16, 2017

Primary Completion Date

March 12, 2018

Study Completion Date

March 12, 2018

Conditions
Actinic KeratosisSquamous Cell Carcinoma
Interventions
DRUG

ingenol disoxate gel 0.018%

Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.

DRUG

ingenol disoxate gel 0.037%

Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.

OTHER

Vehicle gel

Vehicle to ingenol disoxate gel with no active ingredient

Trial Locations (59)

1097

Investigational Site, Dresden

10117

Investigational Site, Berlin

14623

Skin Search of Rochester, Inc., Rochester

20037

The GW Medical Faculty Associates, Washington D.C.

20850

DermAssociates, PC, Rockville

22391

Investigational Site, Hamburg

30078

Gwinnett Clinical Research Center, Inc., Snellville

30159

Investigational Site, Hanover

30263

MedaPhase, Newnan

31008

Investigational Site, Pamplona

32073

Park Avenue Dermatology, Orange Park

33401

Research Institute of the Southeast, LLC, West Palm Beach

33406

Visions Clincal Research, West Palm Beach

37170

Investigational Site, Chambray-lès-Tours

45657

Investigational Site, Recklinghausen

46026

Investigational Site, Valencia

46032

Laser & Skin Surgery Center of Indiana, Carmel

47713

Research Institute of Deaconess Clinic, Evansville

48149

Investigational Site, Münster

48346

Clarkston Skin Research, Clarkston

60590

Investigational Site, Frankfurt am Main

71913

Burke Pharmaceutical Research, Hot Springs

77065

Center for Clinical Studies, Houston

77494

Suzanne Bruce and Associates, P.A., The Center for Skin Research, Katy

78660

Austin Institute for Clinical Research, Inc., Pflugerville

80111

AboutSkin Dermatology and DermSurgery, PC, Greenwood Village

80210

Colorado Medical Research Center, Inc., Denver

89074

Clinical Studies Group, Henderson

92056

Dermatology Specialists, Inc., Oceanside

92117

Skin Surgery Medical Group, Inc., San Diego

92123

Therapeutics Clinical Research, San Diego

University Clinical Trials, Inc., San Diego

92270

Contour Dermatology & Cosmetic Surgery Center, Rancho Mirage

92562

Dermatology Specialists, Inc, Murrieta

92701

Southern California Dermatology, Inc., Santa Ana

94538

Center for Dermatology Clinical Research, Inc., Fremont

97421

Investigational Site, Schweinfurt

99202

Premier Clinical Research, Spokane

06810

Dermatology and Dermatologic Surgery, Danbury

01844

ActivMed Practices & Research, Inc., Methuen

07044

The Dermatology Group, P.C., Verona

V3R 6A7

Investigational Site, Surrey

V6E 4M3

Investigational Site, Vancouver

R3C 0N2

Investigational Site, Winnipeg

E3B 1G9

Investigational Site, Fredericton

L1S 7K8

Investigational Site, Ajax

L4M 7G1

Investigational Site, Barrie

N6A 3H7

Investigational Site, London

L5H 1G9

Investigational Site, Mississauga

K9J 5K2

Investigational Site, Peterborough

N2J 1C4

Investigational Site, Waterloo

J2B 5L4

Investigational Site, Drummondville

06202 Cedex 3

Investigational Site, Nice

42055 Cedex 2

Investigational Site, Saint-Etienne

08916

Investigational Site, Badalona

DD1 9SY

Investigational Site, Dundee

ML6 OJS

Investigational Site, Airdrie

TS4 3BW

Investigational Site, Middlesbrough

RH1 5RH

Investigational Site, Redhill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LEO Pharma

INDUSTRY

NCT03115476 - A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp | Biotech Hunter | Biotech Hunter