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

February 21, 2025 updated by: LEO Pharma

Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle Gel

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

563

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Investigational Site
      • Vancouver, British Columbia, Canada, V6E 4M3
        • Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • Investigational Site
      • Barrie, Ontario, Canada, L4M 7G1
        • Investigational Site
      • London, Ontario, Canada, N6A 3H7
        • Investigational Site
      • Mississauga, Ontario, Canada, L5H 1G9
        • Investigational Site
      • Peterborough, Ontario, Canada, K9J 5K2
        • Investigational Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Investigational Site
    • Quebec
      • Drummondville, Quebec, Canada, J2B 5L4
        • Investigational Site
  • France
      • Chambray les Tours, France, 37170
        • Investigational Site
      • Nice, France, 06202 Cedex 3
        • Investigational Site
      • Saint Etienne, France, 42055 Cedex 2
        • Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Investigational Site
      • Dresden, Germany, 1097
        • Investigational Site
      • Frankfurt am Main, Germany, 60590
        • Investigational Site
      • Hamburg, Germany, 22391
        • Investigational Site
      • Hannover, Germany, 30159
        • Investigational Site
      • Münster, Germany, 48149
        • Investigational Site
      • Recklinghausen, Germany, 45657
        • Investigational Site
      • Schweinfurt, Germany, 97421
        • Investigational Site
  • Spain
      • Valencia, Spain, 46026
        • Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Investigational Site
  • United Kingdom
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Investigational Site
    • Lanarkshire
      • Airdrie, Lanarkshire, United Kingdom, ML6 OJS
        • Investigational Site
    • North Yorkshire
      • Middlesborough, North Yorkshire, United Kingdom, TS4 3BW
        • Investigational Site
    • Surrey
      • Redhill, Surrey, United Kingdom, RH1 5RH
        • Investigational Site
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
    • California
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • Murrieta, California, United States, 92562
        • Dermatology Specialists, Inc
      • Oceanside, California, United States, 92056
        • Dermatology Specialists, Inc.
      • Rancho Mirage, California, United States, 92270
        • Contour Dermatology & Cosmetic Surgery Center
      • San Diego, California, United States, 92117
        • Skin Surgery Medical Group, Inc.
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Diego, California, United States, 92123
        • University Clinical Trials, Inc.
      • Santa Ana, California, United States, 92701
        • Southern California Dermatology, Inc.
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center, Inc.
      • Greenwood Village, Colorado, United States, 80111
        • AboutSkin Dermatology and DermSurgery, PC
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Dermatology and Dermatologic Surgery
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The GW Medical Faculty Associates
    • Florida
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
      • West Palm Beach, Florida, United States, 33401
        • Research Institute of the Southeast, Llc
      • West Palm Beach, Florida, United States, 33406
        • Visions Clincal Research
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research Center, Inc.
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Laser & Skin Surgery Center of Indiana
      • Evansville, Indiana, United States, 47713
        • Research Institute of Deaconess Clinic
    • Maryland
      • Rockville, Maryland, United States, 20850
        • DermAssociates, PC
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research, Inc.
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Clarkston Skin Research
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Clinical Studies Group
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • The Dermatology Group, P.C.
    • New York
      • Rochester, New York, United States, 14623
        • Skin Search of Rochester, Inc.
    • Texas
      • Houston, Texas, United States, 77065
        • Center for Clinical Studies
      • Katy, Texas, United States, 77494
        • Suzanne Bruce and Associates, P.A., The Center for Skin Research
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc.
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle gel
Other: Vehicle gel
Vehicle to ingenol disoxate gel with no active ingredient
Experimental: Ingenol disoxate gel 0.018%
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.
Other Names:
  • LEO 43204
Experimental: Ingenol disoxate gel 0.037%
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 Names:
  • LEO 43204

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area
Time Frame: From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area
Time Frame: 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

Time to first squamous cell carcinoma (SCC) or other skin neoplasia 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 or other skin neoplasia in the treatment area, up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2017

Primary Completion (Actual)

March 12, 2018

Study Completion (Actual)

March 12, 2018

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0084-1369
  • 2017-000228-85 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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