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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31 JCAD journAl oF clinicAl And Aesthetic derMAtology August 2017 • Volume 10 • number 8 A bAckground: ingenol mebutate gel 0.05% once daily for two consecutive days provides high clearance rates for actinic keratosis on a 25cm 2 area of the chest. however, it may cause intense local skin responses. objective: the objective of this study was to determine whether a lower dose of ingenol mebutate gel 0.015% could clear actinic keratosis on the chest with acceptable tolerability and a possible beneficial effect on photodamage and cosmesis. design: this was a noncomparative, open-label study (nct02446223). pArticipAnts: in total, 21 subjects were enrolled, and 20 completed the study. MeAsureMents: ingenol mebutate gel 0.015% was applied once daily for three consecutive days to a contiguous area of the chest less than 100cm 2 containing four or more actinic keratoses. results: the actinic keratosis lesion count decreased by an average of 76 percent compared with baseline. signs of photoaging were reduced significantly at the end of the study, with greater than 60 percent of the subjects reporting moderate or complete satisfaction with skin improvement. Local skin responses generally resolved within two weeks of treatment. there were no adverse reactions. liMitAtions: this was a noncomparative, open-label study that evaluated a relatively small number of subjects. conclusion: ingenol mebutate gel 0.015% applied to a less than 100cm 2 area of the chest once daily for three consecutive days reduced the actinic keratosis count and significantly improved signs of photoaging with high patient satisfaction and good tolerability. key Words: ingenol mebutate, actinic keratosis, local skin response, chest, photoaging, photodamage A b s t r A c t o r i G i n A L r e s e A r c h A prospective pilot clinicAl triAl to evaluate the efficacy and safety of topical therapy with ingenol mebutate Gel 0.015% for Actinic keratosis on an expanded Area of the chest by douglAs c. Wu, Md, phd; isAbellA guihA, bsc; and Mitchel p. goldMAn, Md Drs. Wu and Goldman and ms. Guiha are with cosmetic Laser Dermatology, san Diego, california. J Clin Aesthet Dermatol. 2017;10(8):31–36 Funding: this study was sponsored and funded by Leo Pharma. disclosures: the authors have no conflicts of interest relevant to the contents of this article. Author correspondence: Douglas c. Wu, mD, PhD, dwu@cLDerm.com Actinic kerAtoses (Aks) Are common epidermal lesions on sun-exposed skin from chronic, cumulative ultraviolet (UV) radiation. 1,2 Ak may progress to squamous cell carcinoma (scc), although some experts consider Ak to be scc in situ. 2,3 the risk for progression provides the primary rationale for treatment. 2 An additional inducement for treatment is the cosmetic liability of these lesions. 4 cosmesis following ablation of Ak is important, especially for patients who are concerned about skin appearance, due to cosmetic outcome diWerences across the various Ak treatment options. 5 moreover, patient experience and satisfaction with cosmetic results may influence future decisions to seek treatment for Ak. For isolated Aks, lesion-directed cryosurgery is commonly used. Field treatment, however, has the advantage of ablating not only visible lesions but also subclinical lesions, and it is appropriate when multiple lesions aWect contiguous areas of sun- damaged skin. 6 ingenol mebutate as a field therapy for Ak is approved by the United states Food and Drug Administration (FDA) for use on contiguous 25cm 2 areas on the face or scalp and the trunk or extremities. 7 the dosage is a once-daily application of the 0.015% formulation for three consecutive days for the face or scalp and once-daily use of the 0.05% formulation for two consecutive days for the trunk or extremities. 7,8 the chest, as an area on the trunk, can be especially challenging to treat due to skin diWerences at this site 9 that can aWect healing and also cosmetic results. in the pivotal studies of ingenol mebutate, Aks on the chest were not identified separately from Aks on other nonface/nonscalp areas when the data were analyzed, nor were cosmetic outcomes considered; thus, no conclusions can be drawn from these studies regarding a specific eWect of ingenol mebutate on the chest. 8 in women, the issue of cosmesis often arises when discussing treatment of Ak on the chest due to the occurrence of Ak on the décolletage in association with extensive photodamage. 10 this is most common among women with Fitzpatrick skin

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