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A multicentre, open, investigator-initiated phase IV clinical trial to evaluate the efficacy and safety of ingenol mebutate gel, 0·015% on the face and scalp, and 0·05% on the trunk and extremities, in Korean patients with actinic keratosis (PERFECT)

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dc.contributor.author정기양-
dc.date.accessioned2019-01-15T16:51:05Z-
dc.date.available2019-01-15T16:51:05Z-
dc.date.issued2018-
dc.identifier.issn0007-0963-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/166680-
dc.description.abstractBACKGROUND: Ingenol mebutate gel is a novel, field-directed topical treatment for actinic keratosis (AK). Most pivotal studies have targeted Western populations. No clinical study has been conducted to investigate its efficacy and safety in Asian populations. OBJECTIVES: To evaluate the efficacy and safety of ingenol mebutate gel for treating AK of face/scalp and trunk/extremities in a large Asian (Korean) population. PATIENTS AND METHODS: In this multicentre, open-label, interventional, parallel-group, prospective phase IV study (PERFECT, trial registration no.: NCT02716714), the eligible patients were allocated into either the face/scalp or the trunk/extremities group, according to their selected treatment area location. After application of ingenol mebutate gel, the participants were followed up for 6 months. The primary efficacy endpoint was complete clearance (CC) of AK lesions in the selected treatment area at day 57. Quality of life was evaluated using Skindex-29. Safety endpoints included local skin responses, scar, pigmentation, pain and adverse events. RESULTS: In total, 78·1% [95% confidence interval (CI) 66·86-86·92%] of subjects had CC at day 57, with 76·6% (95% CI 64·31-86·25%) in the face/scalp group and 88·9% (95% CI 51·75-99·72%) in the trunk/extremities group. Among them, CC was sustained in 88·9% (48 of 54, 95% CI 77·37-95·81%) at month 6. The local skin responses significantly increased 1 day after the treatment compared with baseline, and decreased afterwards. Among the total subjects, 7·8% (6 of 77) had hyperpigmentation on the application area. Scars were not reported. CONCLUSIONS: Ingenol mebutate is effective for the treatment of AK in Asians, with tolerable safety profiles.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherBlackwell Scientific Publications-
dc.relation.isPartOfBRITISH JOURNAL OF DERMATOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleA multicentre, open, investigator-initiated phase IV clinical trial to evaluate the efficacy and safety of ingenol mebutate gel, 0·015% on the face and scalp, and 0·05% on the trunk and extremities, in Korean patients with actinic keratosis (PERFECT)-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Dermatology (피부과학교실)-
dc.contributor.googleauthorY.C. Kim-
dc.contributor.googleauthorJ.Y. Yang-
dc.contributor.googleauthorJ.S. Yoon-
dc.contributor.googleauthorS.J. Jo-
dc.contributor.googleauthorH.H. Ahn-
dc.contributor.googleauthorK.‐H. Song-
dc.contributor.googleauthorD.‐Y. Lee-
dc.contributor.googleauthorK.‐Y. Chung-
dc.contributor.googleauthorY.‐H. Won-
dc.contributor.googleauthorI.‐H. Kim-
dc.identifier.doi10.1111/bjd.16368-
dc.contributor.localIdA03582-
dc.relation.journalcodeJ00408-
dc.identifier.eissn1365-2133-
dc.identifier.pmid29355904-
dc.identifier.urlhttps://onlinelibrary.wiley.com/doi/full/10.1111/bjd.16368-
dc.contributor.alternativeNameChung, Kee Yang-
dc.contributor.affiliatedAuthor정기양-
dc.citation.volume179-
dc.citation.number4-
dc.citation.startPage836-
dc.citation.endPage843-
dc.identifier.bibliographicCitationBRITISH JOURNAL OF DERMATOLOGY, Vol.179(4) : 836-843, 2018-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers

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