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An Investigator-initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryosurgery in the Treatment of Hypertrophic Actinic Keratosis on Dorsal Hands.


ABSTRACT: OBJECTIVES:To evaluate the safety and efficacy of ingenol mebutate 0.05% gel after cryosurgery versus cryosurgery alone for the treatment of hypertrophic and nonhypertrophic actinic keratosis on the dorsal hands. DESIGN:Investigator-blinded split arm study. SETTING:Academic institution. PARTICIPANTS:Sixteen subjects with actinic keratoses on dorsal hands. RESULTS:There was a mean reduction in the number of hypertrophic actinic keratosis lesions adjusted for baseline in ingenol mebutate-treated versus control group of -4.3 versus -2.8, respectively. There was a mean reduction in the number of non-hypertrophic actinic keratosis lesions in the ingenol mebutate-treated versus control group of -3.8 versus -0.3. CONCLUSION:A statistically significant and clinically meaningful difference in response was demonstrated in favor of ingenol mebutate-treated hands versus controls. No significant increase in local skin responses was noted when applying ingenol mebutate 0.05% gel on the same day as cryosurgery. TRIAL REGISTRY:ClinicalTrials.gov, NCT02251652.

SUBMITTER: Hashim PW 

PROVIDER: S-EPMC5022999 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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An Investigator-initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryosurgery in the Treatment of Hypertrophic Actinic Keratosis on Dorsal Hands.

Hashim Peter W PW   Nia John K JK   Singer Skylar S   Goldenberg Gary G  

The Journal of clinical and aesthetic dermatology 20160701 7


<h4>Objectives</h4>To evaluate the safety and efficacy of ingenol mebutate 0.05% gel after cryosurgery versus cryosurgery alone for the treatment of hypertrophic and nonhypertrophic actinic keratosis on the dorsal hands.<h4>Design</h4>Investigator-blinded split arm study.<h4>Setting</h4>Academic institution.<h4>Participants</h4>Sixteen subjects with actinic keratoses on dorsal hands.<h4>Results</h4>There was a mean reduction in the number of hypertrophic actinic keratosis lesions adjusted for ba  ...[more]

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