keyword
https://read.qxmd.com/read/33147665/efficacy-and-safety-of-ingenol-disoxate-gel-in-field-treatment-of-actinic-keratosis-on-full-face-scalp-or-large-area-250-cm2-on-the-chest-results-of-four-phase-3-randomized-controlled-trials
#1
RANDOMIZED CONTROLLED TRIAL
Brian Berman, Michael Bukhalo, C William Hanke, Mikala Fiig Jarner, Thomas Larsson, Daniel M Siegel, Torsten Skov, Rolf-Markus Szeimies
INTRODUCTION: Actinic keratosis (AK) is a skin condition arising from chronic exposure to ultraviolet light and may lead to the development of malignancies. This trial aimed to evaluate efficacy and safety of ingenol disoxate gel (IngDsx, 0.018% for face/chest [FC]; 0.037% for scalp [S]), versus vehicle. METHODS: Four identical phase 3 trials in patients with AK on the full face/up to 250cm2 of chest or full balding scalp, with an initial 8-week period and 12-month follow-up, were conducted...
October 15, 2020: Dermatology Online Journal
https://read.qxmd.com/read/29399263/three-day-field-treatment-with-ingenol-disoxate-leo-43204-for-actinic-keratosis-a-phase-ii-trial
#2
JOURNAL ARTICLE
Daniel M Siegel, Stephen Tyring, Walter K Nahm, Marie Louise Østerdal, Astrid H Petersen, Brian Berman
OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of ingenol disoxate gel using a once-daily, three-day field treatment regimen in patients with actinic keratosis. DESIGN: This was a Phase II, multicenter, open-label trial (clinicaltrials.gov: NCT02305888). SETTING: The study was conducted in 20 trial sites in the United States. PARTICIPANTS: Participants included patients with 5 to 20 clinically typical actinic keratosis lesions on the full face/chest (250cm2 ), scalp (25-250cm2 ), or the trunk/extremities (250cm2 )...
December 2017: Journal of Clinical and Aesthetic Dermatology
https://read.qxmd.com/read/29399258/three-day-field-treatment-with-ingenol-disoxate-leo-43204-for-actinic-keratosis-cosmetic-outcomes-and-patient-satisfaction-from-a-phase-ii-trial
#3
JOURNAL ARTICLE
Brian Berman, Stephen Tyring, Walter K Nahm, Marie Louise Østerdal, Astrid H Petersen, Daniel M Siegel
Objective: To report cosmetic outcomes and patient satisfaction with ingenol disoxate (LEO 43204) used in a once-daily, three-day field treatment regimen in patients with actinic keratosis. Design: This was a phase II, multicenter, open-label trial (ClinicalTrials.gov: NCT02305888) involving 20 trial sites in the United States. Participants: Patients with between five and 20 clinically typical actinic keratoses lesions on the full face/250cm2 on the chest, 25cm2 to 250cm2 on the scalp, or 250cm2 on the trunk/extremities were included...
November 2017: Journal of Clinical and Aesthetic Dermatology
https://read.qxmd.com/read/29296668/chemical-proteomics-identifies-slc25a20-as-a-functional-target-of-the-ingenol-class-of-actinic-keratosis-drugs
#4
JOURNAL ARTICLE
Christopher G Parker, Christian A Kuttruff, Andrea Galmozzi, Lars Jørgensen, Chien-Hung Yeh, Daniel J Hermanson, Yujia Wang, Marta Artola, Steven J McKerrall, Christopher M Josyln, Bjarne Nørremark, Georg Dünstl, Jakob Felding, Enrique Saez, Phil S Baran, Benjamin F Cravatt
The diterpenoid ester ingenol mebutate (IngMeb) is the active ingredient in the topical drug Picato, a first-in-class treatment for the precancerous skin condition actinic keratosis. IngMeb is proposed to exert its therapeutic effects through a dual mode of action involving (i) induction of cell death that is associated with mitochondrial dysfunction followed by (ii) stimulation of a local inflammatory response, at least partially driven by protein kinase C (PKC) activation. Although this therapeutic model has been well characterized, the complete set of molecular targets responsible for mediating IngMeb activity remains ill-defined...
December 27, 2017: ACS Central Science
https://read.qxmd.com/read/29204958/pharmacokinetics-and-safety-of-ingenol-disoxate-gel-administered-under-maximum-use-conditions-to-patients-with-actinic-keratosis
#5
MULTICENTER STUDY
Edward Lain, Torsten Skov, Anders Hall
BACKGROUND AND OBJECTIVES: Ingenol disoxate (LEO 43204) is a field therapy in development for the treatment of actinic keratosis (AK) on areas between 25 and 250 cm2 . We evaluated the systemic exposure and safety of ingenol disoxate under maximum-use conditions. METHODS: This was a phase I, open-label, non-randomized, multicenter trial. Patients ≥ 18 years of age with ≥ 15 clinically typical, visible, discrete AK lesions in a treatment area on the full face or approximately 250 cm2 on the arm or scalp were treated once-daily for 3 consecutive days with ingenol disoxate 0...
March 2018: Clinical Drug Investigation
https://read.qxmd.com/read/28264612/a-dose-finding-trial-with-a-novel-ingenol-derivative-ingenol-disoxate-leo-43204-for-field-treatment-of-actinic-keratosis-on-full-face-or-250-cm-2-on-the-chest
#6
RANDOMIZED CONTROLLED TRIAL
Marc Bourcier, Linda Stein Gold, Lyn Guenther, Camilla M Andreassen, Johan Selmer, Gary Goldenberg
PURPOSE: Actinic keratoses (AKs) may progress to squamous cell carcinoma and can occur in cancerized fields as sub-clinical and clinically visible lesions. Ingenol disoxate gel is a topical field therapy for AK. This Phase I/II trial aimed to assess the safety and efficacy of ingenol disoxate on full face or chest in patients with AKs. MATERIALS AND METHODS: Part 1 was a phase-I, open-label, dose-escalation trial investigating the maximum tolerated dose of ingenol disoxate...
November 2017: Journal of Dermatological Treatment
https://read.qxmd.com/read/28078678/a-seamless-phase-i-ii-dose-finding-trial-assessing-ingenol-disoxate-leo-43204-for-field-treatment-of-actinic-keratosis-on-the-scalp
#7
RANDOMIZED CONTROLLED TRIAL
J Weiss, M Ulrich, M Bukhalo, M L Østerdal, B Bang, C W Hanke
BACKGROUND: Actinic keratosis (AK) is a common sun-related skin condition, which can progress to squamous cell carcinoma and occur in cancerized fields. OBJECTIVES: To investigate in a phase I/II trial the safety and efficacy of ingenol disoxate as topical field therapy for patients with AK on the balding scalp. METHODS: Part 1 was a phase I, open-label, dose-escalation trial investigating up to six doses of ingenol disoxate to determine the maximum tolerated dose (MTD)...
June 2017: British Journal of Dermatology
https://read.qxmd.com/read/27503482/ingenol-disoxate-a-novel-4-isoxazolecarboxylate-ester-of-ingenol-with-improved-properties-for-treatment-of-actinic-keratosis-and-other-non-melanoma-skin-cancers
#8
JOURNAL ARTICLE
Malene Bertelsen, Martin Stahlhut, Gunnar Grue-Sørensen, Xifu Liang, Gitte Bach Christensen, Kresten Skak, Karen Margrethe Engell, Thomas Högberg
INTRODUCTION: Ingenol mebutate gel (Picato® , LEO Pharma A/S) is approved for the field treatment of actinic keratosis and is characterized by high sustained clearance of actinic lesions. The inherent propensity of ingenol mebutate towards chemical rearrangement necessitates refrigeration of the final product. We sought to identify novel ingenol derivatives with enhanced chemical stability and similar or improved in vitro potency and in vivo efficacy. METHODS: A number of ingenol esters were synthesized with full regiocontrol from ingenol...
December 2016: Dermatology and Therapy
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