Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

Actinic Keratosis Clinical Trial

Official title: An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. For the first cycle of study application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1 baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale (VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15, in which LSR will be assessed and photographs taken. Approximately four weeks later, a second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied to the same treatment area on the face or scalp. Subjects will be followed during treatment on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken. Post-treatment follow-up for the second cycle of application will occur on day 36, day 43, and day 56. During these post-treatment follow-up visits LSR and photographs will be taken. LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29 and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

• NCT number: NCT01836367
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Completion date: August 2013