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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)
DC Field | Value | Language |
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dc.contributor.author | 정기양 | - |
dc.date.accessioned | 2019-01-15T16:51:05Z | - |
dc.date.available | 2019-01-15T16:51:05Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0007-0963 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/166680 | - |
dc.description.abstract | BACKGROUND: 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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Blackwell Scientific Publications | - |
dc.relation.isPartOf | BRITISH JOURNAL OF DERMATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | 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) | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Dermatology (피부과학교실) | - |
dc.contributor.googleauthor | Y.C. Kim | - |
dc.contributor.googleauthor | J.Y. Yang | - |
dc.contributor.googleauthor | J.S. Yoon | - |
dc.contributor.googleauthor | S.J. Jo | - |
dc.contributor.googleauthor | H.H. Ahn | - |
dc.contributor.googleauthor | K.‐H. Song | - |
dc.contributor.googleauthor | D.‐Y. Lee | - |
dc.contributor.googleauthor | K.‐Y. Chung | - |
dc.contributor.googleauthor | Y.‐H. Won | - |
dc.contributor.googleauthor | I.‐H. Kim | - |
dc.identifier.doi | 10.1111/bjd.16368 | - |
dc.contributor.localId | A03582 | - |
dc.relation.journalcode | J00408 | - |
dc.identifier.eissn | 1365-2133 | - |
dc.identifier.pmid | 29355904 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.16368 | - |
dc.contributor.alternativeName | Chung, Kee Yang | - |
dc.contributor.affiliatedAuthor | 정기양 | - |
dc.citation.volume | 179 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 836 | - |
dc.citation.endPage | 843 | - |
dc.identifier.bibliographicCitation | BRITISH JOURNAL OF DERMATOLOGY, Vol.179(4) : 836-843, 2018 | - |
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