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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

Primary Purpose

Actinic Keratosis, Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ingenol disoxate gel 0.018%
ingenol disoxate gel 0.037%
Vehicle gel
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Actinic Keratosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Burke Pharmaceutical Research
  • Center for Dermatology Clinical Research, Inc.
  • Dermatology Specialists, Inc
  • Dermatology Specialists, Inc.
  • Contour Dermatology & Cosmetic Surgery Center
  • Skin Surgery Medical Group, Inc.
  • Therapeutics Clinical Research
  • University Clinical Trials, Inc.
  • Southern California Dermatology, Inc.
  • Colorado Medical Research Center, Inc.
  • AboutSkin Dermatology and DermSurgery, PC
  • Dermatology and Dermatologic Surgery
  • The GW Medical Faculty Associates
  • Park Avenue Dermatology
  • Research Institute of the Southeast, LLC
  • Visions Clincal Research
  • MedaPhase
  • Gwinnett Clinical Research Center, Inc.
  • Laser & Skin Surgery Center of Indiana
  • Research Institute of Deaconess Clinic
  • DermAssociates, PC
  • ActivMed Practices & Research, Inc.
  • Clarkston Skin Research
  • Clinical Studies Group
  • The Dermatology Group, P.C.
  • Skin Search of Rochester, Inc.
  • Center for Clinical Studies
  • Suzanne Bruce and Associates, P.A., The Center for Skin Research
  • Austin Institute for Clinical Research, Inc.
  • Premier Clinical Research
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ingenol disoxate gel 0.018%

Ingenol disoxate gel 0.037%

Vehicle gel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2017
Last Updated
October 8, 2019
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03115476
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume; participants are no longer being examined.
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis, Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
563 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ingenol disoxate gel 0.018%
Arm Type
Experimental
Arm Title
Ingenol disoxate gel 0.037%
Arm Type
Experimental
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ingenol disoxate gel 0.018%
Other Intervention Name(s)
LEO 43204
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ingenol disoxate gel 0.037%
Other Intervention Name(s)
LEO 43204
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vehicle gel
Intervention Description
Vehicle to ingenol disoxate gel with no active ingredient
Primary Outcome Measure Information:
Title
Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area
Description
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
Time Frame
From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months
Secondary Outcome Measure Information:
Title
Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area
Description
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
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Dermatology Specialists, Inc
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Dermatology Specialists, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Contour Dermatology & Cosmetic Surgery Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Skin Surgery Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University Clinical Trials, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Colorado Medical Research Center, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
AboutSkin Dermatology and DermSurgery, PC
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Dermatology and Dermatologic Surgery
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
The GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Research Institute of the Southeast, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Visions Clincal Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
MedaPhase
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Gwinnett Clinical Research Center, Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Laser & Skin Surgery Center of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Research Institute of Deaconess Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
DermAssociates, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ActivMed Practices & Research, Inc.
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Clinical Studies Group
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
The Dermatology Group, P.C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Suzanne Bruce and Associates, P.A., The Center for Skin Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 4M3
Country
Canada
Facility Name
Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Investigational Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Investigational Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Investigational Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Investigational Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
Investigational Site
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Investigational Site
City
Nice
ZIP/Postal Code
06202 Cedex 3
Country
France
Facility Name
Investigational Site
City
Saint Etienne
ZIP/Postal Code
42055 Cedex 2
Country
France
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site
City
Dresden
ZIP/Postal Code
1097
Country
Germany
Facility Name
Investigational Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigational Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Investigational Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigational Site
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Investigational Site
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Investigational Site
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Investigational Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Investigational Site
City
Airdrie
State/Province
Lanarkshire
ZIP/Postal Code
ML6 OJS
Country
United Kingdom
Facility Name
Investigational Site
City
Middlesborough
State/Province
North Yorkshire
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Investigational Site
City
Redhill
State/Province
Surrey
ZIP/Postal Code
RH1 5RH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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