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
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.
Timeline
- Start
- 2017-06-16
- Primary completion
- 2018-03-12
- Completion
- 2018-03-12
Outcome
Missed primary endpoint
Stopped: “Study halted prematurely and will not resume; participants are no longer being examined.”
registry p = 0.43; Hazard Ratio (HR) 1.43 (95% CI 0.61 to 3.9) NCT03115476 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ingenol disoxate | Small molecule | 0.018 % | — |
| Subject | Ingenol disoxate | Small molecule | 0.037 % | — |