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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31 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 the three previously treated AKs (on the treated side of the original split-face study), the three previously untreated AKs (on the untreated side of the split-face study), and the chronically sun- exposed skin surrounding these AKs identified in the original study. Evaluations were performed at baseline (Day 0) in an outpatient clinic setting, after which ingenol mebutate gel 0.015% was applied by the patient at home once daily for three consecutive days (Days 1, 2, and 3) to the area of the face containing three previously untreated AKs and the perilesional skin. Clinical assessment was repeated, and the lesions were photographed after the third application of ingenol mebutate on Day 3. Patients returned on Day 60 for clinical reassessment and repeat dermoscopy and OCT imaging. Lesions were classified as (typical) AK, hypertrophic AK, or SCC in situ (Bowen's disease; bowenoid AK), based mainly on OCT criteria but also on clinical appearance, when visible, and histopathology, when available. The photographs of clinical lesions also were used to assess local skin responses (LSRs) as none, mild, moderate, or severe. Statistical analysis was performed using the paired t-test, chi-square test, and Fisher's exact test to determine statistical significance. For purposes of statistical analysis, we also classified lesions as clinical (visible) lesions (AK + non-AK), subclinical lesions (subclinical AK + subclinical non-AK), and total lesions (clinical + subclinical lesions). RESULTS Of the 30 patients enrolled in the original study, 15 of them subsequently participated in the extension phase. Of the 15 nonparticipant patients from the original study, two did not return for follow-up during the original study (see above), eight declined to participate, four could not be contacted, and one was denied entry due to a medical comorbidity. Facial areas that were treated during the original study primarily maintained their clearance during the extension study. In the original study, there was a statistically significant reduction (P<0.00001) in the average number of clinical lesions per patient from Day 0 to Day 60 following treatment (Figure 1A). At one year later, on Day 0 of the extension study, clinical lesion counts remained low in those patients enrolled in the extension study (Figure 1B). Thus, there was no statistically significant difference between the number of lesions (AK and subclinical AK) present at the end of the original study and the number of lesions present at the beginning of the extension study for both treated (P<0.262) and untreated groups (P<0.959) (Figures 2A and 2B). Clearance rates of clinical and subclinical lesions from the original split-face untreated side that were subsequently treated in this extension study were comparable to rates achieved in the original study. In the original study, 79 percent of the 92 clinical and subclinical lesions (including hypertrophic AKs and SCC in situ, as well as typical AKs) diagnosed by OCT were cleared at Day 60 after treatment. In contrast, only 17 percent of the 69 untreated clinical and subclinical lesions diagnosed by OCT were spontaneously clear at Day 60. These untreated lesions were subsequently treated in the extension study and exhibited 69 percent FIGURE 4. Clearance of all treated clinical and subclinical lesions after treatment in the original and extension studies—error bars=95% confidence interval; *actinic keratosis (AK), hypertrophic AK, squamous cell carcinoma (SCC) in situ (Bowen's disease; bowenoid AK)

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