Journal of Clinical and Aesthetic Dermatology

OCT 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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29 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY October 2017 • Volume 10 • Number 10 O R I G I N A L R E S E A R C H of additional AKs and potentially reduce the risk of future progression to SCC. Clinically visible AKs and the surrounding normal-appearing skin within the field of cancerization can be identified by biopsy 4 or specialized imaging, 5,7 including reflectance-mode confocal microscopy 6–9 and optical coherence tomography (OCT). 4,8,10–12 In an effort to utilize reliable diagnostic tools that are noninvasive and therefore might spare the patient a biopsy, we conducted a pilot study involving OCT diagnosis of patients treated with ingenol mebutate gel 0.015%. In 2016, we reported the results of this open-label, split-face study that was designed primarily to delineate actinic field cancerization by comparing OCT with conventional histopathology for the identification of clinical and subclinical AKs. 4 To correlate OCT, histopathologic, and clinical diagnoses, OCT imaging followed by biopsy was used to examine clinically identified AKs and the sun-exposed perilesional skin. We found that OCT analysis had a 100-percent correlation with the clinical diagnosis of AK and also detected 79 percent of histopathologically confirmed subclinical lesions from perilesional skin sites that appeared clinically normal. The study was furthermore designed to determine the efficacy of ingenol mebutate gel 0.015% for field-directed treatment of clinical AKs and for subclinical AKs on sun-exposed perilesional skin. The results showed that ingenol mebutate effectively cleared AK, particularly clinically characteristic lesions. 4 Given the statistically significant results for clearance and the diagnostic potential of OCT, we conducted the current study as an extension of the original study. Our objectives were 1) to determine whether the AKs successfully treated during the original study remained clear one year later and 2) to treat the previously untreated clinical AKs (from the untreated side of the original split-face study) and any subclinical lesions on the photodamaged perilesional skin. METHODS This was a single-center, single-arm, open- label extension of an original clinical study completed one year earlier. The methodology of the extension phase was similar to that of the original study, which has been reported previously. 4 Briefly, in the original study, patients were required to have at least seven clinical AKs on the face in three separate areas, including three lesions on each side of the face. Patients were excluded if they had a history or evidence of skin conditions other than AK or if lesions that exhibited an atypical appearance were identified within the treatment area. In total, 30 Caucasian male patients 18 years of age or older with a past history of AK treatment were enrolled. Two of the patients did not return for follow-up and were not included in the analysis. The 28 patients who completed the original study were invited to participate in the extension study one year later. Those patients who were eligible and enrolled in the extension study provided written informed consent and allowed the clinical research staff to take photographs of the selected facial lesions. Patients were evaluated by clinical assessment, dermoscopy, and OCT imaging (VivoSight® OCT Scanner, Michelson Diagnostics; Maidstone, Kent, United Kingdom) to track the behavior of FIGURE 1. Previously treated lesions—mean number of clinical lesions per patient between Day 0 and Day 60 of the original study in the treated group (A); mean number of clinical lesions between Day 0 and Day 60 in the extension study (all lesions were treated on Day 0) (B); solid arrows indicate transition from Day 0 to Day 60 for each study; dotted arrow indicates 1-year transition from Day 60 of original study to Day 0 of extension study; error bars=95% confidence interval; NS=not significant

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