Dissecting the mechanism of action of tirbanibulin in AK
Research type
Research Study
Full title
Dissecting the Mechanism of Action of Tirbanibulin versus 5-Fluorouracil in Actinic Keratosis
IRAS ID
335277
Contact name
John Lear
Contact email
Sponsor organisation
Northern Care Alliance NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Non-Melanoma Skin Cancer accounts for over 150,000 cases of cancer each year, by far the most common form of cancer in the UK. Of these, Cutaneous Squamous Cell Carcinoma (cSCC) makes up approximately 25% of cases. The number of cases diagnosed each year has increased 2.5 fold in the last 30 years. cSCC has the potential to spread in the body in up to 1% of cases, and therefore is a significant source of cancer-related morbidity and mortality. The outcomes of cSCC are much better when it is diagnosed and treated early.
Actinic Keratosis (AK) is a type of sun damage that has the potential to develop into cSCC. AK is often treated with different cream-based medications. Therefore, improving the understanding of how AK develops, and how best to treat it, is important as will reduce the number of cases that develop into cSCC.
This project aims to explain how different cream-based treatments work in AK by performing biopsies on skin before and after treatment, and examining the immune system changes triggered by treatment. It will compare the changes following a newly approved medication, tirbanibulin, with an existing commonly used treatment for AK, 5-fluorouracil. This will identify which medication is most adept at initiating an immune response within the skin. Overall, the project will potentially allow for a greater understanding of the differences in the mechanism of action of different topical treatments used for the treatment of AK, which may provide evidence for the development of new drugs targeting similar pathways, or suggest a rationale for the combinations of treatments that may be more effective than single drugs used alone.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
24/EM/0096
Date of REC Opinion
18 Jun 2024
REC opinion
Further Information Favourable Opinion