Journal of Clinical and Aesthetic Dermatology

AUG 2017

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

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34 JCAD journAl oF clinicAl And Aesthetic derMAtology August 2017 • Volume 10 • number 8 o r i G i n A L r e s e A r c h intermediate between mildly and moderately satisfied (Figure 4). All subjects completed survey questions in the effectiveness, convenience, and overall satisfaction domains of the 14-item tsQm at one day after the last application of ingenol mebutate gel (Day 3) and at the end of the study (Day 59). All tsQm domain scores were less than 70 on Day 59; the convenience scores (91 at Days 3 and 59) were the highest of the four domains and likely reflect satisfaction with the three-day treatment regimen (Figure 5). only subjects who indicated that they experienced any side effects of the medication (n=15 and n=8 on Days 3 and 59, respectively) answered questions in the side effects domain. safety. Lsr developed within one day of treatment, generally peaked one day after the last application, and declined over the next 14 days (Figure 6). scores for erythema were the highest across the six parameters. the mean composite Lsr score (sum of the 6 individual r eactions) at one day after the last application was 6.8. no adverse events were reported. discussion ingenol mebutate gel 0.05% applied once daily for two consecutive days is indicated for the treatment of Ak on a 25cm 2 contiguous area of the chest. however, this formulation may cause intense Lsr at this site. therefore, we conducted a study to evaluate the efficacy, safety, and effect on photodamaged skin of ingenol mebutate gel, 0.015%—the concentration approved for use on the face and scalp—applied once daily for three consecutive days. subjects who presented with four or more Ak lesions applied the ingenol mebutate on an expanded contiguous area of the chest, up to 100cm 2 . At Day 59, the lesion count was reduced by an average of 76 percent as compared with baseline. this lesion reduction was comparable to the 75-percent median reduction in Ak lesion count at Day 57 found in the pivotal Phase 3 studies, in which the trunk and extremities were treated with ingenol mebutate gel 0.05% applied once daily for two consecutive days. 8 only a small subset of the subjects in the pivotal studies, however, treated Ak of the chest specifically. 7 the calculated mean composite Lsr score (6.8) of subjects in the present study appeared to be lower than that of subjects in a Phase 3b study who used the 0.05% formulation to treat Ak on the chest (mean composite score, approximately 10–14). 12 however, the results are not directly comparable, because subjects in the pivotal studies and the Phase 3b study treated an area of 25cm 2 and not up to 100cm 2 , as in our study. nevertheless, the results suggest that treatment of Ak on the chest with ingenol mebutate gel 0.015% once daily for three consecutive days delivers clinically meaningful clearance of Ak and may be more tolerable than ingenol mebutate gel 0.05% once daily for two consecutive days. Figure 3. subject self-assessment of improvement in photoaging signs at Day 59 after ingenol mebutate gel 0.015% treatment Figure 4. improved subject satisfaction in photoaging signs from Day 10 to Day 59 after ingenol mebutate gel 0.015% treatment

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