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Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses

Actinic Keratoses Clinical Trial

Official title:
An Investigator-Initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses (AK) on Dorsal Hands

Clinical Trial Summary

Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore, use of ingenol mebutate will also be evaluated for potential treatment of subclinical lesions.

Clinical Trial Description

The investigators plan to treat 30 subjects. Each qualifying subject will have at least 3 hypertrophic AKs, defined as more than 3mm in thickness, on each dorsal hand. Cryotherapy will be standardized in all patients and for all treated lesions: 1-2 sprays, 5 seconds each, with a 5 second interval. All subjects will be treated with the same cryo-spray. Following cryotherapy, subjects will be randomized to treat either their right or left dorsal hand with ingenol mebutate gel. The decision to treat the right vs. the left hand will be chosen by chance, like flipping a coin. Neither the subject nor the study doctor will choose what arm receives the ingenol mebutate gel. The study doctor will not know which arm is treated with ingenol mebutate, so the subject should not reveal that information to him or her at any time during the study. Subjects will treat the randomized dorsal hand with ingenol mebutate 0.05% gel starting on the same day as the cryotherapy (Day 0). Subjects will utilize the once daily for two days regimen. Subjects will be followed on day 4 after their initial visit, day 8, day 15, day 29, and day 57, with a two day window period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02251652
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Active, not recruiting
Phase Phase 4
Start date April 2013
Completion date August 2015
View Details
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