ALM014_PhIII_Efficacy/Safety Actikerall_Actinic Keratoses_02JUL2014
Research type
Research Study
Full title
Multicentre, randomized, parallel, double-blind, vehicle controlled study to evaluate the efficacy and safety of Actikerall® solution in the filed-directed treatment of actinic keratoses grade I to II (Filed cancerization).
IRAS ID
159865
Contact name
Wayne Turner
Contact email
Sponsor organisation
Almirall Hermal GmbH
Eudract number
2014-001171-31
Clinicaltrials.gov Identifier
ADP18998, Project code; ALM014, CRO Trial code (TFS)
Research summary
Actinic Keratosis is common skin disease that is characterized by small crusty, scaly or crumbly lesions of skin that appear on persistently sun-exposed skin surfaces. These lesions may progress to squamous cell carcinomas (a common type of skin cancer), although the progression rate is quite low. However, due to the inability to predict which lesion will progress to squamous cell carcinoma all lesions require treatment. Actikerall® is a solution to treat actinic keratosis (grade I/II) in adult patients with a healthy immune system. Almirall Hermal GmbH, an affiliate of the Spanish pharmaceutical company Almirall S.A is sponsoring this clinical research study.
This study will be carried out at approximately 14 sites from 2 countries in Europe: UK and Germany. The study will start around October 2014, when the first patient is expected to enter the study, and will end around August 2015, when the last patient is expected to finish the treatment. A total of 146 patients are required to complete the study. Patients who enter the study will need to have 4-10 actinic keratosis lesions (grade I and II) in an area of 25 cm² on the face, scalp and/or forehead. They will be treated over a 12 week period. The total duration of the trial for each patient will be between 20 and 22 weeks, and patients will need to attend 7 study visits to the site.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1240
Date of REC Opinion
23 Oct 2014
REC opinion
Further Information Favourable Opinion