Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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). Among the current therapies for
the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage,
topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for
therapy, however as with other lesion-directed therapies, cryosurgery does not treat
subclinical lesions in the surrounding skin. 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. The goal of AK therapy for all physicians is to provide an
effective, tissue-sparing treatment with good cosmetic results. 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, one common fear about ingenol
mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin,
and that retreatment would produce an equally, if not more, caustic result on the skin such
as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and
demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower
LSR scores compared to the LSR in the first cycle of application. We plan to treat 20
subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2
treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol
mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be
started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days
regimen for both cycles.