LP0084-1369
Research type
Research Study
Full title
Incidence of squamous cell carcinoma and other skin neoplasia in subjects with actinic keratosis treated with ingenol disoxate gel 0.018% or 0.037%, or vehicle
IRAS ID
226652
Contact name
SANDEEP CLIFF
Contact email
Sponsor organisation
Leo Pharma A/S
Eudract number
2017-000228-85
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Actinic keratosis (AK) is a common skin condition visible as thick, scaly, crusty patches of skin (called lesions or Actinic keratoses). AKs develop on areas 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).
In legacy trials conducted in the UK (LP0084-1193 and LP0084-1195), the interventional medicinal product, ingenol disoxate, or vehicle gel, was applied once daily for 3 consecutive days on an area of the scalp, face or chest to treat AKs (deemed as the selected treatment area). The patients were followed up for 14 months. This trial will continue the follow up of patients treated in the legacy trial for an additional 2 years. The primary objective is to compare the incidence of SCC after treatment with ingenol disoxate gel and vehicle gel. There is no additional investigational medicinal product in this trial.
To be eligible, patients must have participated in the LP0084-1193 or LP084-1195 trials, having been treated with either ingenol disoxate or vehicle gel, and continued their follow up to month 14 of the legacy trial.
Patients will be seen every 6 months, starting from the date of month 14 from the legacy trial. At these visits, patients will be reviewed for scarring assessments, any adverse events in the treatment area (of the legacy trial), any concomitant medications used in the treatment area (of the legacy trial). This trial will be conducted at NHS hospitals.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0690
Date of REC Opinion
30 May 2017
REC opinion
Further Information Favourable Opinion