Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm
actinic keratosis
field cancerization
field treatment
ingenol mebutate
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Mar 2020
Mar 2020
Historique:
received:
21
11
2018
revised:
18
07
2019
accepted:
23
07
2019
pubmed:
3
8
2019
medline:
18
9
2020
entrez:
3
8
2019
Statut:
ppublish
Résumé
Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified. Localized skin responses hindered maintenance of double-blinding. IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm
Sections du résumé
BACKGROUND
BACKGROUND
Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm
OBJECTIVE
OBJECTIVE
To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm
METHODS
METHODS
This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm
RESULTS
RESULTS
IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified.
LIMITATIONS
CONCLUSIONS
Localized skin responses hindered maintenance of double-blinding.
CONCLUSIONS
CONCLUSIONS
IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm
Identifiants
pubmed: 31374304
pii: S0190-9622(19)32476-4
doi: 10.1016/j.jaad.2019.07.083
pii:
doi:
Substances chimiques
3-ingenyl angelate
0
Diterpenes
0
Gels
0
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
642-650Informations de copyright
Copyright © 2020. Published by Elsevier Inc.