Journal of Clinical and Aesthetic Dermatology

Ingenol Mebutate Topical Gel 2016

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

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S6 JCAD journal of clinical and aesthetic dermatology November 2016 • Volume 9 • Number 11 group, OpSite occlusion group, and no occlusion group, respectively. § The complete histologic clearance rates (CHCR) were 70.4, 37.5, and 54.2 percent in the aluminum disk group, OpSite occlusion group, and no occlusion group, respectively. § Efficacy results supported greater therapeutic benefit with aluminum disc occlusion of IMG 0.05 percent, with 22/27 subjects treated with this regimen using only a single application of IMG. § LSRs occurred as anticipated, similar in magnitude and duration to what occurred in pivotal trials of IMG for AKs, although a higher degree of LSRs occurred with occlusion; no unexpected safety signals occurred in any of the study groups. Scarring was noted as a potential complication in subjects who utilized occlusion (4/51 subjects). Dyspigmentation was also noted in some subjects, both with or without occlusion. § IMG proved to be ineffective overall for treatment of SK with the regimens utilized in this study. 24 • Study. A randomized, double-blind, vehicle-controlled, dose-finding Phase 2a study evaluated IMG used for treatment of superficial BCC ranging in size from 0.4 to 1.5cm (N=60). 25 The majority of subjects were male, with a mean age range of 56 to 61 years; Fitzpatrick skin types were I, II, and III. Lesions were located on the shoulder (n=20), chest (n=11), arm (n=10), back (n=10), leg (n=5), neck (n=3), and face (n=1). Group A received a single application on Day 1 and on Day 2 of IMG 0.0025% (n=8), IMG 0.01% (n=8), or IMG 0.05% (n=8). Group B received a single application on Day 1 and on Day 8 of IMG 0.0025% (n=8), IMG 0.01% (n=8), or IMG 0.05% (n=8). Of 60 randomized subjects, 58 received both applications of their study medication (IMG of designated strength). Efficacy was evaluated by both clinical and histological assessment on Day 85. 25 § The greatest CCCR and CHCR was observed with IMG 0.05% applied once on two consecutive days (Group A) (Figure 1). § No patient in any study group experienced worsening of their treated lesion. § No correlation trends were noted with IMG treatments and lesion size or lesion location. There was some suggestion of correlation between lesion clearance and intensity of LSR, especially in Group A. Figures 2A–2C. A 2.5 cm nodular BCC on the right temple treated with IMG 0.015% applied daily on 3 consecutive days. Figure 2A (top) is at baseline. Figure 2B (middle) is at Day 10. Figure 2C (bottom) is at Day 37 and demonstrated complete clinical clearance and excellent healing. IMG was used in this case due to the general medical status of the patient which obviated surgery and other modalities, and also ease of use. Close follow-up is warranted over time to assure that clearance of BCC is sustained. A B C

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