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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S9 JCAD journal of clinical and aesthetic dermatology November 2016 • Volume 9 • Number 11 located on the head and neck region, and/or were >2cm in diameter. At one month follow-up after one or two treatment courses, the clinical response was 94 percent, and 7 of 8 patients who underwent post-treatment biopsy were clear histologically. The reported efficacy outcome at last follow-up was a 75-percent complete clinical response overall (12/16 patients) and 100 percent for SCC in-situ lesions measuring <1.6cm (10/10 patients). • Case series. Although not demonstrating the same extent of full-thickness epidermal involvement as SCC in-situ, actinic cheilitis (defined here as AK involving the visible mucosal lip [vermillion]), is a common precursor to invasive SCC. 30 To add, the lip is noted to be a location of greater propensity for development of metastatic SCC. In a report of four cases treated with IMG 0.15% applied once daily for three consecutive days, two of the four patients treated for actinic cheilitis cases were cleared. As mucosa is being treated as compared to keratinized skin, brisk LSRs may occur within a few days. The patients in this case report series were elderly (69–77 years of age) and two cases were refractory to previous cryotherapy. 30 Author commentary. The Phase 1/2 study results (although not using the commercially available gel formulation), these three case reports of challenging SCC in- situ lesions, and assessment of therapeutic responses with OCT and histology with AK therapy provide support for the use of IMG in selected cases of SCC in-situ where the clinical size, anatomic location, and/or patient-specific factors obviate use of surgical therapy or other modalities. 22,27,29 There are multiple medical and surgical therapies that have been reported for treatment of SCC in- situ, each with certain advantages and disadvantages. 16 The regimens used above for facial and extremity lesions are logical coupled with close long-term follow-up, with use of the regimen utilized on the extremity lesions also rational for truncal or scalp SCC in-situ. Actinic chelitis may also be treated with IMG 0.015% once daily for three days, with marked LSRs anticipated. Repeated courses of therapy may be warranted depending on initial response with treatment of both SCC in-situ at any anatomic site or with actinic cheilitis. Human Papilloma Virus-Induced Lesions • IMG 0.015% and 0.05% have been used for the treatment of human papilloma virus (HPV)-induced verrucae, especially for lesions involving the anogenitalia (anogenital warts [AGW]). 31,32 § Case series. IMG was used for treatment of AGW in 17 adult patients (age range 21–70 years; 15 males, 2 females). 3 1,32 The complete clearance rate was 94 percent (16/17) within up to 35 days of follow-up (Figure 4). A single treatment cycle was used in 14 of 17 cases. Patients requiring 2 or 3 treatment cycles exhibited a longer duration of AGWs and thicker/fibrotic/more indurated AGW lesions. Partial response was noted in one immunocompromised patient undergoing treatment with oral cyclosporine. § IMG 0.05% was used to treat 13 patients and IMG 0.015% was used to treat four patients; a single treatment cycle was described as one application of IMG. § LSRs occurred in the above case series within 1 to 2 days after IMG application, which generally subsided over the following 2 to 5 days. • Case report. IMG 0.15% has been used successfully to treat multiple facial lesions of multi-treatment resistant epidermodysplasia verruciformis (EV) in a 38-year-old woman, with some lesions exhibiting presence of NMSC. 33 EV is a rare genodermatosis associated with persistent HPV. 33 Author commentary. Verrucae (VV), including both AGW and common warts, are among the most challenging cutaneous disorders from a management perspective as lesions are often multiple and persistent and/or recurrent despite various therapies. IMG offers a viable option with the advantage of a more rapid visible clinical effect as compared to some other topical therapies that are used in some cases of VV (i.e., salicylic acid, imiquimod, 5-FU, retinoids). 34 Although data are limited, the reported modes of action of IM support its use in the treatment of HPV infections, including VV and AGW, especially as there is both initial necrosis and potential for a more prolonged inflammatory-immunologic effect. Single application appears rational depending on the size and anatomic location of the lesions. Greater care is suggested when treating mucosal surfaces and head and neck lesions. Application near the eye may not be prudent. Repeated courses of therapy may be needed based on clinical response, which can be assessed earlier than with many other topical therapies used to treat VV and AGW. Whether or not occlusion can increase efficacy for treatment of VV is not clear at present. Other Reported Dermatologic Diagnoses Case reports have been published reporting therapeutic benefit with use of IM for molluscum contagiosum,

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