Ingenol Mebutate vs. Diclofenac in subjects with AK on face or scalp
Research type
Research Study
Full title
Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.
IRAS ID
172460
Contact name
Mohammed Alif
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2014-003218-98
Clinicaltrials.gov Identifier
3732, CCRN
Duration of Study in the UK
0 years, 11 months, 12 days
Research summary
Actinic keratosis (AK) is a common skin condition visible as thick, scaly, crusty patches of skin called solar keratoses, actinic keratoses, or an AK lesion. Actinic keratoses (AKs) usually develop on areas of skin that are frequently exposed to the sun. If left untreated, an AK lesion may progress to a squamous cell carcinoma (SCC) – a common form of skin cancer. Patients that present with numerous AKs are often treated with a topical treatment (a cream/ointment/gel that is applied to the skin).
This study will involve a topical product called ingenol mebutate 0.015% gel (marketed as Picato® in the UK) and the comparator diclofenac sodium gel 3% (marketed as Solaraze™ in UK), with both products being used to treat AKs.
This study will explore the efficacy of one 3-day ingenol mebutate gel treatment course compared to diclofenac sodium gel used for 90 days in patients with AKs on the face and scalp. The efficacy of up to two ingenol mebutate treatment courses will also be compared to diclofenac sodium gel.
To be eligible, subjects would see a dermatologist (a physician with skin disease as specialty) for the treatment of their AKs and have 4-8 AKs within a selected treatment area of 25cm2 on the face or scalp. Enrolled patients will be treated with ingenol mebutate 0.015% gel once daily for 3 consecutive days, or diclofenac sodium gel, twice daily application, for 90 days. For patients receiving ingenol mebutate gel, if any AKs remain within the treated area after 8 weeks, the treatment will be repeated with the same medication. Patients will in total attend 2 or 3 study visits, depending on the treatment arm they are on. At the last study visit, they will complete a Treatment Satisfaction Questionnaire.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0050
Date of REC Opinion
2 Mar 2015
REC opinion
Further Information Favourable Opinion