dm+d

31231007

Lactation Safety Information

For use in the ear

For use in the ear
Yes
No risk to the breastfeeding infant
30 October 2020

For oral hygiene

For oral hygiene
Yes
24 September 2020

For skin disinfection

For skin disinfection
Yes
Avoid contact of the infant with treated areas
24 September 2020

New Medicines

Eskeriele [UK]; Eskata [EU,US] Seborrhoeic keratosis

Information

Eskeriele [UK]; Eskata [EU,US]
New formulation
Aclaris Therapeutics
Aclaris Therapeutics

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Aug 19Aclaris Therapeutics withdraw marketing licence of Eskata in the EU and discontinue sales in the US. The decision to discontinue commercialisation of Eskata is business related and not due to the safety and efficacy of the product [5,6].
Feb 19Approved by the Swedish Medical Products Agency. Eskata 685mg cutaneous solution is licensed for the treatment of seborrheic keratosis that are not pedunculated and have up to a maximum diameter of 15 mm each. Also approved by the MHRA in the UK as Eskeriele [3,4].
Dec 17US FDA approves 40% topical solution of hydrogen peroxide for the treatment of raised seborrheic keratosis, and subsequently the product was launched in the US [2].
Aug 17Aclaris Therapeutics submits a Marketing Authorization Application (MAA) with the Medicines Product Agency (MPA) in Sweden for 40% topical hydrogen peroxide for the treatment of seborrheic keratosis. The MPA will act as the reference member state in the decentralized procedure for review of the MAA for potential marketing approval throughout Europe. If approved, topical hydrogen peroxide 40% would be available to be commercialised in 16 countries in the European Union. The application is supported by data from two phase III SEBK 301 and SEBK 302 trials [2].

Category

A non-invasive treatment, that works by penetrating into the SK lesion and causing oxidative damage, which can ultimately result in the sloughing of the SK cells
Seborrhoeic warts (also known as seborrhoeic keratoses) are common benign, hyperkeratotic skin lesions associated with ageing. Presence and frequency increases with age: almost all elderly patients have some. It has been estimated that over 90% of adults aged 60 or more have at least one seborrhoeic wart [1].
Seborrhoeic keratosis
Topical

Trial or other data

Nov 16Aclaris Therapeutics releases positive top-line results from the two PIII SEBK 302 and SEBK 301 trials, in seborrhoeic keratosis (NCT02667275; NCT02667236). The two pivotal trials evaluated safety and efficacy of topical hydrogen peroxide 40% in patients with seborrhoeic keratosis on trunk, extremities and face. Patients in each trial had four target SK lesions, including at least one on the face and at least one on the trunk or extremities. Each lesion received up to two treatments three weeks apart. The randomised, double-blind trials completed enrolment of 937 patients in all, in the US [2].

Evidence based evaluations