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

NCT03115476 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: LP0084-13692017-000228-85
• Study Type: interventional
• Target: 563
• Locations: 6 countries
• Sites: 59

Brief Summary

One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.

Conditions

Actinic Keratosis; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area

  Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis

  From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months

Secondary Outcomes (1)

• Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area

  From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months

Study Arms (3)

Ingenol disoxate gel 0.018%

EXPERIMENTAL

Drug: ingenol disoxate gel 0.018%

Ingenol disoxate gel 0.037%

EXPERIMENTAL

Drug: ingenol disoxate gel 0.037%

Vehicle gel

PLACEBO COMPARATOR

Other: Vehicle gel

Interventions

ingenol disoxate gel 0.018% DRUG

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.

Also known as: LEO 43204

Ingenol disoxate gel 0.018%

ingenol disoxate gel 0.037% DRUG

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.

Also known as: LEO 43204

Ingenol disoxate gel 0.037%

Vehicle gel OTHER

Vehicle to ingenol disoxate gel with no active ingredient

Vehicle gel

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent has been obtained.
• The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at the end of follow-up visit (month 14) of that trial.

You may not qualify if:

• The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area .
• The subject is enrolled in any other interventional clinical trial.
• For subjects where there is a gap between end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:
• The subject has been treated with ingenol mebutate or ingenol disoxate in the selected treatment area after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
• The subject has been enrolled in any other interventional clinical trial after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (59)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Dermatology Specialists, Inc

Murrieta, California, 92562, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

Contour Dermatology & Cosmetic Surgery Center

Rancho Mirage, California, 92270, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

Southern California Dermatology, Inc.

Santa Ana, California, 92701, United States

Location

Colorado Medical Research Center, Inc.

Denver, Colorado, 80210, United States

Location

AboutSkin Dermatology and DermSurgery, PC

Greenwood Village, Colorado, 80111, United States

Location

Dermatology and Dermatologic Surgery

Danbury, Connecticut, 06810, United States

Location

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Research Institute of the Southeast, LLC

West Palm Beach, Florida, 33401, United States

Location

Visions Clincal Research

West Palm Beach, Florida, 33406, United States

Location

MedaPhase

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Research Institute of Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

DermAssociates, PC

Rockville, Maryland, 20850, United States

Location

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, 01844, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48346, United States

Location

Clinical Studies Group

Henderson, Nevada, 89074, United States

Location

The Dermatology Group, P.C.

Verona, New Jersey, 07044, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Center for Clinical Studies

Houston, Texas, 77065, United States

Location

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

Katy, Texas, 77494, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Investigational Site

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigational Site

Vancouver, British Columbia, V6E 4M3, Canada

Location

Investigational Site

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Investigational Site

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Investigational Site

Ajax, Ontario, L1S 7K8, Canada

Location

Investigational Site

Barrie, Ontario, L4M 7G1, Canada

Location

Investigational Site

London, Ontario, N6A 3H7, Canada

Location

Investigational Site

Mississauga, Ontario, L5H 1G9, Canada

Location

Investigational Site

Peterborough, Ontario, K9J 5K2, Canada

Location

Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigational Site

Drummondville, Quebec, J2B 5L4, Canada

Location

Investigational Site

Chambray-lès-Tours, 37170, France

Location

Investigational Site

Nice, 06202 Cedex 3, France

Location

Investigational Site

Saint-Etienne, 42055 Cedex 2, France

Location

Investigational Site

Berlin, 10117, Germany

Location

Investigational Site

Dresden, 1097, Germany

Location

Investigational Site

Frankfurt am Main, 60590, Germany

Location

Investigational Site

Hamburg, 22391, Germany

Location

Investigational Site

Hanover, 30159, Germany

Location

Investigational Site

Münster, 48149, Germany

Location

Investigational Site

Recklinghausen, 45657, Germany

Location

Investigational Site

Schweinfurt, 97421, Germany

Location

Investigational Site

Badalona, Barcelona, 08916, Spain

Location

Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Investigational Site

Valencia, 46026, Spain

Location

Investigational Site

Dundee, Angus, DD1 9SY, United Kingdom

Location

Investigational Site

Airdrie, Lanarkshire, ML6 OJS, United Kingdom

Location

Investigational Site

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

Investigational Site

Redhill, Surrey, RH1 5RH, United Kingdom

Location

MeSH Terms

Conditions

Keratosis, Actinic; Carcinoma, Squamous Cell

Interventions

LEO 43204

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: LEO Pharma

disclosure@leo-pharma.com

+45 4494 5888

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: June 16, 2017
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: March 11, 2025
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); CA (11); US (30); ES (3); GB (4); FR (3)