Hashim Peter W, Nia John K, Singer Skylar, Goldenberg Gary
The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
J Clin Aesthet Dermatol. 2016 Jul;9(7):16-22. Epub 2016 Jul 1.
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.
Investigator-blinded split arm study.
Academic institution.
Sixteen subjects with actinic keratoses on dorsal hands.
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.
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.
ClinicalTrials.gov, NCT02251652.
评估0.05% 鬼臼毒素酯凝胶在冷冻手术后与单纯冷冻手术相比，治疗手背肥厚性和非肥厚性光化性角化病的安全性和有效性。
研究者设盲的双臂研究。
学术机构。
16名手背部患有光化性角化病的受试者。
在调整基线后，鬼臼毒素酯治疗组与对照组相比，肥厚性光化性角化病病变数量的平均减少分别为 -4.3 和 -2.8。鬼臼毒素酯治疗组与对照组相比，非肥厚性光化性角化病病变数量的平均减少分别为 -3.8 和 -0.3。
结果表明，与对照组相比，鬼臼毒素酯治疗的手部在反应上存在统计学显著且具有临床意义的差异。在冷冻手术当天应用0.05% 鬼臼毒素酯凝胶时，未观察到局部皮肤反应有显著增加。
ClinicalTrials.gov，NCT02251652。
