Duration of Ameluz Application in Acral Actinic Keratoses Response
Research type
Research Study
Full title
A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
IRAS ID
255992
Contact name
Alison Curnow
Contact email
Sponsor organisation
Royal Cornwall Hospitals NHS Trust
Eudract number
2019-003150-86
Duration of Study in the UK
1 years, 2 months, 5 days
Research summary
Photodynamic therapy (PDT) is a treatment for skin cancer and sun-damaged skin, which may turn cancerous. PDT treatment consists of applying a gel containing aminolevulinic acid hydrochloride (Ameluz®) to the abnormal area. Inside the diseased cells this gel is changed over a few hours into a light-sensitive chemical (photosensitiser) that reacts with light. The photosensitiser is inactive by itself. A red light is then shone on to the lesion; this reacts with the photosensitiser and destroys the abnormal cells. Only the treated area will be affected and inflamed.
Actinic keratosis (AK) is a type of pre-cancerous lesion caused by sun damage. If left, they can progress to become skin cancer. These can be treated in different ways, with different topical creams, liquid nitrogen or PDT. Some lesions may have reoccurred after topical creams, have unacceptable amount of inflammation or involve too large an area. Liquid nitrogen is as good as PDT in treating AKs, however have been reported to leave a less good cosmetic result.
PDT is a licensed treatment for AK. However, PDT has been shown to be less effective for AKs on certain areas such as hands and feet. Further understanding of the build-up of the photosensitiser may enable better cure rates at these body parts, enabling more patients to benefit from PDT.
The proposed theory is that a longer application of the Ameluz gel will increase the amount of photosensitiser, which accumulates in the treated areas, and thus more patients receiving successful treatment.
The aim of this study is to investigate whether applying the Ameluz gel for 4 hours (trial arm) rather than 3 hours (control arm) will improve treatment success rates in AK lesions on hands, feet, arms and legs. The information gained from this study may result in better treatment design of PDT for AK.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0922
Date of REC Opinion
9 Jul 2019
REC opinion
Further Information Favourable Opinion