drugset / Trial / NCT02411851

Treatment of Actinic Keratoses (AK) on the Face

NCT02411851

RandomizedParallel-groupSingle-blindTreatment

Summary

Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Ingenol mebutate is the active compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been approved for the treatment of AKs. Ingenol mebutate gel 0.015% has shown to not only have a high clearance rate but also a transient localized inflammatory skin response that resolves quickly without sequelae. However, these localized skin responses (eg erythema, erosion/ulceration, edema, etc.) can often be unpleasant and unsightly. Currently, there are no clinical studies evaluating combination therapies (eg topical steroids, emollients) with ingenol mebutate 0.015% that would decrease irritation and improve wound healing while maintaining efficacy.

Timeline

Start
2015-03
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ingenol mebutate Small molecule 0.015 % Topical

Indications