drugset / Trial / NCT01926496
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment
Timeline
- Start
- 2013-09-11
- Primary completion
- 2019-07-11
- Completion
- 2019-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imiquimod | Other / unclassified | 5 % | Topical |
| Subject | ingenol mebutate | Small molecule | 0.015 % | Topical |