Actinic KeratosisPhase 3NCT03115476
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
A Phase 3 study testing ingenol disoxate gel 0.018% and ingenol disoxate gel 0.037% in people with Actinic Keratosis and Squamous Cell Carcinoma, run by LEO Pharma at 59 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Actinic Keratosis, Squamous Cell Carcinoma
- What is being tested?
- ingenol disoxate gel 0.018% and ingenol disoxate gel 0.037%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 563 participants
- Where
- 59 sitesin 6 countries
- Study dates
- 16 Jun 2017to 12 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
59 sites in 6 countries.
59 sites in 6 countries
United States30 sites
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Clarkston Skin Research
Clarkston, Michigan, 48346
Dermatology and Dermatologic Surgery
Danbury, Connecticut, 06810
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
Research Institute of Deaconess Clinic
Evansville, Indiana, 47713
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
AboutSkin Dermatology and DermSurgery, PC
Greenwood Village, Colorado, 80111
Clinical Studies Group
Henderson, Nevada, 89074
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Center for Clinical Studies
Houston, Texas, 77065
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Katy, Texas, 77494
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, 01844
Dermatology Specialists, Inc
Murrieta, California, 92562
MedaPhase
Newnan, Georgia, 30263
Dermatology Specialists, Inc.
Oceanside, California, 92056
Park Avenue Dermatology
Orange Park, Florida, 32073
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, 92270
Skin Search of Rochester, Inc.
Rochester, New York, 14623
DermAssociates, PC
Rockville, Maryland, 20850
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Therapeutics Clinical Research
San Diego, California, 92123
University Clinical Trials, Inc.
San Diego, California, 92123
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Premier Clinical Research
Spokane, Washington, 99202
The Dermatology Group, P.C.
Verona, New Jersey, 07044
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401
Visions Clincal Research
West Palm Beach, Florida, 33406
Canada11 sites
Investigational Site
Ajax, Ontario, L1S 7K8
Investigational Site
Barrie, Ontario, L4M 7G1
Investigational Site
Drummondville, Quebec, J2B 5L4
Investigational Site
Fredericton, New Brunswick, E3B 1G9
Investigational Site
London, Ontario, N6A 3H7
Investigational Site
Mississauga, Ontario, L5H 1G9
Investigational Site
Peterborough, Ontario, K9J 5K2
Investigational Site
Surrey, British Columbia, V3R 6A7
Investigational Site
Vancouver, British Columbia, V6E 4M3
Investigational Site
Waterloo, Ontario, N2J 1C4
Investigational Site
Winnipeg, Manitoba, R3C 0N2
Germany8 sites
Investigational Site
Berlin, 10117
Investigational Site
Dresden, 1097
Investigational Site
Frankfurt am Main, 60590
Investigational Site
Hamburg, 22391
Investigational Site
Hanover, 30159
Investigational Site
Münster, 48149
Investigational Site
Recklinghausen, 45657
Investigational Site
Schweinfurt, 97421
United Kingdom4 sites
Investigational Site
Airdrie, Lanarkshire, ML6 OJS
Investigational Site
Dundee, Angus, DD1 9SY
Investigational Site
Middlesbrough, North Yorkshire, TS4 3BW
Investigational Site
Redhill, Surrey, RH1 5RH
France3 sites
Investigational Site
Chambray-lès-Tours, 37170
Investigational Site
Nice, 06202 Cedex 3
Investigational Site
Saint-Etienne, 42055 Cedex 2
Spain3 sites
Investigational Site
Badalona, Barcelona, 08916
Investigational Site
Pamplona, Navarre, 31008
Investigational Site
Valencia, 46026
About this study
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
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
- Being tested
- ingenol disoxate gel 0.018%, ingenol disoxate gel 0.037%, Vehicle gel
- Medical subject headings
- Keratosis, Actinic, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ingenol disoxate gel 0.018%Drug
Also called LEO 43204
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.
ingenol disoxate gel 0.037%Drug
Also called LEO 43204
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.
Vehicle gelOther
Vehicle to ingenol disoxate gel with no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Ingenol disoxate gel 0.018% | Experimental | Not described Receives: Drug: ingenol disoxate gel 0.018% |
| Ingenol disoxate gel 0.037% | Experimental | Not described Receives: Drug: ingenol disoxate gel 0.037% |
| Vehicle gel | Placebo comparator | Not described Receives: Other: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start16 Jun 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115476
- Sponsor's protocol ID
- LP0084-1369
- Other IDs
- 2017-000228-85, 2017
- Status last verified
- Jun 2019
- First submitted
- 5 Apr 2017
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03115476
- Acronym / sponsor ID
- LP0084-1369
- Conditions
- Actinic Keratosis, Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined.
- Enrolment
- 563 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ingenol disoxate gel 0.018%Also: LEO 43204Ingenol 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 0.018% |
| ingenol disoxate gel 0.037%Also: LEO 43204Ingenol 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% |
| Vehicle gelVehicle to ingenol disoxate gel with no active ingredient | Other | Vehicle gel |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
59 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ingenol disoxate gel 0.018% and ingenol disoxate gel 0.037% in people with Actinic Keratosis and Squamous Cell Carcinoma, run by LEO Pharma at 59 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Canada, Germany, United Kingdom, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.