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

LEO Pharma

Status and phase: Terminated; Phase 3

Conditions: Squamous Cell Carcinoma; Actinic Keratosis

Treatments: Other: Vehicle gel; Drug: ingenol disoxate gel 0.037%; Drug: ingenol disoxate gel 0.018%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03115476

LP0084-1369

2017-000228-85 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 563 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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563 participants in 3 patient groups, including a placebo group

Ingenol disoxate gel 0.018%

Experimental group

Treatment:

Drug: ingenol disoxate gel 0.018%

Ingenol disoxate gel 0.037%

Experimental group

Treatment:

Drug: ingenol disoxate gel 0.037%

Vehicle gel

Placebo Comparator group

Treatment:

Other: Vehicle gel