Journal of Clinical and Aesthetic Dermatology

DEC 2017

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

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22 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY December 2017 • Volume 10 • Number 12 O R I G I N A L R E S E A R C H 2, Figure 2). The majority of patients in the trial were male (face/chest, 63.5%; scalp, 98.4%; trunk/extremities, 62.9%) and had a mean (standard deviation [SD]) age of 64.0 (8.8) years in the face/chest group, 67.7 (9.6) years in the scalp group, and 66.7 (9.6) years in the trunk/ extremities group. The median duration of AK was seven years for the face/chest group, 10 years for the scalp group, and seven years for the trunk/extremities group (Table 2). Nine patients in the face/chest group, 10 patients in the scalp group, and 16 patients in the trunk/extremities group had hypertrophic/hyperkeratotic lesions at baseline. The majority of patients completed the eight-week follow-up, except one patient in the scalp group who withdrew due to an adverse event (AE) and one patient in the trunk/ extremities group who was lost to follow-up. Safety. A total of nine patients (14.3%) reported DLEs in the face/chest group, no DLEs were reported in the scalp treatment group, and 11 patients (17.7%) reported DLEs in the trunk/ extremities group. Mean composite LSR scores peaked at Day 4 with values of 10.5 for the face/ chest group, 10.4 for the scalp treatment group, and 9.1 for the trunk/extremities treatment group (Figure 3). In the face/chest and scalp groups, these scores declined rapidly after peaking, reaching mild levels by Week 2 and baseline levels by Week 4, respectively. In the trunk/extremities group, these scores remained high until Day 8, then rapidly declined, reaching mild levels by Week 2 and approaching baseline levels by Week 4 (Figure 3). Throughout the trial, erythema was the most common LSR component in each treatment group (Figure 4). Vesiculation/pustulation and swelling were relatively high at Day 4, but quickly approached baseline levels thereafter. The least common LSR component was erosion/ulceration in each treatment group throughout the trial period (Figure 4). Of the Grade 4 LSRs, erythema was the most common (face/chest, n=7; scalp, n=13; trunk/extremities, n=13). Flaking/scaling was the next most common Grade 4 LSR reported by patients (face/chest, n=3; scalp, n=4; trunk/ extremities, n=7); similar proportions were reported for crusting, swelling, and vesiculation/ pustulation. No patients had Grade 4 erosion/ ulceration (Figure 4). Overall, LSR components resolved by Week 8 (Figure 4); vesiculation/ pustulation and erosion/ulceration resolved by Week 4 in the majority of patients. This is reflected in the composite LSR scores (Figure 3). Adverse events were reported by 35 patients (55.6%) in the face/chest group, 47 patients (74.6%) in the scalp group, and 43 (69.4%) in the trunk/extremities group. Nine patients had 12 AEs of severe intensity (3 [4.8%] patients in each treatment group). Treatment-related AEs were reported by 32 patients (50.8%) in the face/chest group, 44 patients (69.8%) in the scalp group, and 41 patients (66.1%) in the trunk/extremities group. Treatment-related AEs of severe intensity were application site pain (n=1 in each treatment group), application site discomfort (scalp, n=1; trunk/extremities, n=2), application site pruritus (scalp, n=1; trunk/extremities, n=1), application site dermatitis (face/chest, n=1), and eyelid irritation (scalp, n=1). One patient in the face/chest group reported a serious AE (SAE) of inguinal hernia, which was considered as not related to treatment by the investigator. One patient in the scalp group had an AE of migraine that led to withdrawal from the trial. Two patients in the trunk/extremities group reported SCC in the treatment area; one patient had one SCC considered possibly related to the treatment by the investigator and one patient had two SCCs considered probably related to treatment by the investigator. The most common treatment- related AE was application site pain, reported by 28 patients (44.4%) in the face/chest group, 34 patients (54.0%) in the scalp group, and 26 patients (41.9%) in the trunk/extremities group (Table 3). No deaths were reported during the trial. Efficacy. For nonhyperkeratotic/hypertrophic lesions, reduction in AK lesion count from baseline to Week 8 was 78.9 percent (95% CI 70.9%, FIGURE 2. Patient disposition FIGURE 3. Composite local skin response (LSR) score: thin lines denote individual scores; bold lines denote mean scores

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