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Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm2 on the chest: A phase 3 randomized controlled trial - 11/02/20

Doi : 10.1016/j.jaad.2019.07.083 
C. William Hanke, MD, MPH, FACP a, , Lorne Albrecht, MD, FRCPC b, Torsten Skov, MD, PhD c, Thomas Larsson, Dr Med Sci c, Marie Louise Østerdal, MSc c, Lynda Spelman, MD, MBBS, FACD d
a Laser and Skin Surgery Center of Indiana, Carmel, Indiana 
b Enverus Medical, Surrey, British Columbia, Canada 
c LEO Pharma A/S, Ballerup, Denmark 
d Veracity Clinical Research, Brisbane, Queensland, Australia 

Correspondence to: C. William Hanke, MD, MPH, FACP, Laser and Skin Surgery Center of Indiana, Dermatologic Surgery, Indianapolis, Indiana 46032.Laser and Skin Surgery Center of IndianaDermatologic SurgeryIndianapolisIndiana46032

Abstract

Background

Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm2 or less; some patients require treatment of larger fields.

Objective

To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm2 during an 8-week initial assessment period and extended 12-month follow-up.

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 cm2) or chest (approximately 250 cm2). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm2 on the chest. The primary endpoint was complete AK clearance (AKCLEAR 100; week 8). Additional endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome, and safety.

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

Localized skin responses hindered maintenance of double-blinding.

Conclusions

IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm2. The safety profile of IngMeb was as expected.

Le texte complet de cet article est disponible en PDF.

Key words : actinic keratosis, field cancerization, field treatment, ingenol mebutate

Abbreviations used : 5-FU, AE, AK, AKCLEAR 100, AKCLEAR 75, IngMeb, LSR


Plan


 Funding sources: Supported by LEO Pharma (trial and medical writing support).
 Disclosure: Dr Hanke has served on advisory boards for LEO Pharma (honoraria) and Genentech (no compensation received); has received grants from LEO Pharma; has been an investigator for Athenex (grant), Biofrontera (grant), Endo International (grant), and Pelle Pharm (grant); and has consulted for LEO Pharma (honoraria) and Sun Pharma (honoraria). Dr Albrecht is a principal investigator for LEO Pharma (grant), Valeant Pharmaceuticals (grant), and Galderma (grant) and has received consultant honoraria from LEO Pharma, Valeant Pharmaceuticals, and Galderma. Dr Skov, Dr Larsson, and Ms Østerdal are salaried employees of LEO Pharma. Dr Spelman has served on advisory boards for AbbVie (personal fees), Eli Lilly (personal fees), Galderma (personal fees), and Novartis (personal fees); has undertaken sponsored clinical research for AbbVie (grants), Amgen (grants), Anacor (grants), Ascend Biopharmaceuticals (grants), Astellas (grants), Australian Wool Innovation Limited (grants), Blaze Bioscience (grants), Celgene (grants), Dermira (grants), Eli Lilly (grants), Galderma (grants), Genentech (grants), GlaxoSmithKline (grants), Kythera (grants), Leo Pharma (grants), Merck (grants), Novartis (grants), Phosphagenics (grants), Regeneron (grants), Sanofi (grants), and Trius (grants); and has received sponsored travel from Abbott (nonfinancial support), Novartis (nonfinancial support), and Janssen-Cilag (nonfinancial support).
 Reprints not available from the authors.


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Vol 82 - N° 3

P. 642-650 - mars 2020 Retour au numéro
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