A multi-centre, 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)

Publication Date:
2018-01-22
Publisher:
Wiley-Blackwell
Print ISSN:
0007-0963
Electronic ISSN:
1365-2133
Topics:
Medicine
Published by:
http://www.wiley.com/wiley-blackwell
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autor Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
beschreibung 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. Methods In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects 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 subjects were followed-up for 6 months. The primary efficacy endpoint was complete clearance (CC) rate of AK lesions in the selected treatment area on Day 57. The 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% CI: 66.86–86.92%) of subjects had CC on day 57, with 76.6% (95% CI: 64.31–86.25%) in face/scalp group and 88.9% (95% CI: 51.75–99.72%) in trunk/extremities group. Among them, the CC rate was sustained in 88.9% (48/54 subjects, 95% CI: 77.37–95.81%) on Month 6. The local skin responses significantly increased 1 day after the treatment compared to baseline, and decreased afterwards. Among the total subjects, 7.8% (6/77 subjects) 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. This article is protected by copyright. All rights reserved.
citation_standardnr 6143564
datenlieferant ipn_articles
feed_id 5432
feed_publisher Wiley-Blackwell
feed_publisher_url http://www.wiley.com/wiley-blackwell
insertion_date 2018-01-22
journaleissn 1365-2133
journalissn 0007-0963
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher Wiley-Blackwell
quelle British Journal of Dermatology
relation http://onlinelibrary.wiley.com/resolve/doi?DOI=10.1111%2Fbjd.16368
search_space articles
shingle_author_1 Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
shingle_author_2 Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
shingle_author_3 Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
shingle_author_4 Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
shingle_catch_all_1 A multi-centre, 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)
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. Methods In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects 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 subjects were followed-up for 6 months. The primary efficacy endpoint was complete clearance (CC) rate of AK lesions in the selected treatment area on Day 57. The 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% CI: 66.86–86.92%) of subjects had CC on day 57, with 76.6% (95% CI: 64.31–86.25%) in face/scalp group and 88.9% (95% CI: 51.75–99.72%) in trunk/extremities group. Among them, the CC rate was sustained in 88.9% (48/54 subjects, 95% CI: 77.37–95.81%) on Month 6. The local skin responses significantly increased 1 day after the treatment compared to baseline, and decreased afterwards. Among the total subjects, 7.8% (6/77 subjects) 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. This article is protected by copyright. All rights reserved.
Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
Wiley-Blackwell
0007-0963
00070963
1365-2133
13652133
shingle_catch_all_2 A multi-centre, 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)
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. Methods In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects 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 subjects were followed-up for 6 months. The primary efficacy endpoint was complete clearance (CC) rate of AK lesions in the selected treatment area on Day 57. The 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% CI: 66.86–86.92%) of subjects had CC on day 57, with 76.6% (95% CI: 64.31–86.25%) in face/scalp group and 88.9% (95% CI: 51.75–99.72%) in trunk/extremities group. Among them, the CC rate was sustained in 88.9% (48/54 subjects, 95% CI: 77.37–95.81%) on Month 6. The local skin responses significantly increased 1 day after the treatment compared to baseline, and decreased afterwards. Among the total subjects, 7.8% (6/77 subjects) 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. This article is protected by copyright. All rights reserved.
Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
Wiley-Blackwell
0007-0963
00070963
1365-2133
13652133
shingle_catch_all_3 A multi-centre, 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)
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. Methods In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects 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 subjects were followed-up for 6 months. The primary efficacy endpoint was complete clearance (CC) rate of AK lesions in the selected treatment area on Day 57. The 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% CI: 66.86–86.92%) of subjects had CC on day 57, with 76.6% (95% CI: 64.31–86.25%) in face/scalp group and 88.9% (95% CI: 51.75–99.72%) in trunk/extremities group. Among them, the CC rate was sustained in 88.9% (48/54 subjects, 95% CI: 77.37–95.81%) on Month 6. The local skin responses significantly increased 1 day after the treatment compared to baseline, and decreased afterwards. Among the total subjects, 7.8% (6/77 subjects) 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. This article is protected by copyright. All rights reserved.
Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
Wiley-Blackwell
0007-0963
00070963
1365-2133
13652133
shingle_catch_all_4 A multi-centre, 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)
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. Methods In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects 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 subjects were followed-up for 6 months. The primary efficacy endpoint was complete clearance (CC) rate of AK lesions in the selected treatment area on Day 57. The 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% CI: 66.86–86.92%) of subjects had CC on day 57, with 76.6% (95% CI: 64.31–86.25%) in face/scalp group and 88.9% (95% CI: 51.75–99.72%) in trunk/extremities group. Among them, the CC rate was sustained in 88.9% (48/54 subjects, 95% CI: 77.37–95.81%) on Month 6. The local skin responses significantly increased 1 day after the treatment compared to baseline, and decreased afterwards. Among the total subjects, 7.8% (6/77 subjects) 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. This article is protected by copyright. All rights reserved.
Y. C. Kim, J. Y. Yang, J. S. Yoon, S. J. Jo, H. H. Ahn, K.-H. Song, D.-Y. Lee, K.-Y. Chung, Y.-H. Won, I.-H. Kim
Wiley-Blackwell
0007-0963
00070963
1365-2133
13652133
shingle_title_1 A multi-centre, 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)
shingle_title_2 A multi-centre, 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)
shingle_title_3 A multi-centre, 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)
shingle_title_4 A multi-centre, 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)
timestamp 2025-06-30T23:32:11.156Z
titel A multi-centre, 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)
titel_suche A multi-centre, 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)
topic WW-YZ
uid ipn_articles_6143564