Histological examination confirms clinical clearance of actinic keratoses following treatment with ingenol mebutate 0.05% gel

被引:9
|
作者
Ulrich, M. [1 ,2 ]
Reinhold, U. [3 ]
Skov, T. [4 ]
Sondergaard, R. Elvang [4 ]
Guitera, P. [5 ,6 ]
机构
[1] Charite Univ Med Berlin, Dept Dermatol, Charitepl 1, Berlin, Germany
[2] Dermatol Regierungsviertel Coll Med, Berlin, Germany
[3] Dermatol Ctr Bonn, Dept Dermatol, Friedenspl, Bonn, Germany
[4] LEO Pharma AS, Ballerup, Denmark
[5] Univ Sydney, Sydney Melanoma Diagnost Ctr, Sydney, NSW, Australia
[6] Univ Sydney, Melanoma Inst Australia, Discipline Dermatol, Sydney, NSW, Australia
关键词
SQUAMOUS-CELL CARCINOMA; REFLECTANCE CONFOCAL MICROSCOPY; FIELD CANCERIZATION; SKIN; TRIAL; DIAGNOSIS; ACID;
D O I
10.1111/bjd.14968
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background To date, studies with ingenol mebutate gel have used clinical clearance, not histological clearance, as a primary efficacy endpoint. Objectives This phase I, multicentre, single-arm, open-label study sought to confirm histologically the clinical clearance of actinic keratoses (AKs) to support a treatment effect deep in the epidermis. Methods Patients (n = 108) aged >= 18 years with histologically confirmed AK within a 25-cm(2) contiguous treatment area on the trunk and extremities received ingenol mebutate 0.05% gel for two consecutive days and were followed up on day 3 and week 8. One AK was randomly preselected at day 1 for clinical and histological evaluation at week 8 and for reflectance confocal microscopy (RCM) in a subset of patients. The primary endpoint was clinical and histological clearance of AKs at week 8. Results The observed agreement rate between clinical and histological assessments of clearance of a single AK was 81.9% and the positive predictive value of a clinical assessment of clearance was 87%. Agreement between the two pathologists was 88%. The common composite 8-week complete clearance rate was 41% (95% confidence interval 32-50). Observed agreement rates between RCM and pathologist I and II assessments of clearance were 72.9% and 81.4%, respectively. Overall, 30 patients (27.8%) experienced 38 adverse events (AEs). Application-site pain (four patients, 3.7%) was the most common treatment-related AE inside the treatment area. Conclusions Ingenol mebutate achieves histopathological clearance of AKs that correlates with observed clinical clearance. Clinical clearance is a good predictor for histological clearance.
引用
收藏
页码:71 / 80
页数:10
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