CLFX453X2201
Research type
Research Study
Full title
A randomized, vehicle controlled, active comparator, parallel group study to evaluate safety, tolerability and preliminary efficacy of topical LFX453 formulations in patients with actinic keratosis
IRAS ID
169855
Contact name
Mads Soerensen
Contact email
Sponsor organisation
Novartis Institutes for BioMedical Research (NIBR)
Eudract number
2014-003613-28
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Actinic keratosis (AK), are pre-malignant cancerous skin lesions that develop in response to prolonged sun exposure. The lesions may in time develop into invasive cancer.
Toll-like-receptor 7 (TLR7) is an essential component of the immune system, and TLR7 stimulators such as Aldara are approved for the treatment of AK, however other immune responses are also stimulated leading to undesirable side effects, especially skin irritation.
LFX453 is a stimulator of TLR7 with the potential to offer similar effect with fewer side effects.
In this study, two creams of LFX453 will be tested for their tolerability, safety, and efficacy against their matching placebos (inactive creams). Aldara, is included for comparison.
Following a screening period of up to 4 weeks, all five different creams will be dosed for two 4-week intervals separated by a 4-week pause. After the end of treatment patients will enter an 8 week follow-up period before completing the study. A total of 80 patients are expected to enter the study.
In order to be eligible, patients must be 18-75 years, male, or female of non-childbearing potential, have at least 5 AK lesions within a 25 cm2 area on the face and/or scalp, and an additional AK lesion outside the intended treatment area. Patients must not have any concomitant illness that could confound the clinical evaluation of AK. In situ skin cancer types are allowed if completely removed before the start of the study.
Patients will during the study undergo clinical evaluation of AK and local irritation, as well as physical examinations, blood draws, and ECGs for safety assessments. Blood will be drawn for analysis of drug in the blood and certain proteins in the blood.
Optional to the patients are skin biopsies taken for analysis of proteins and drug levels in the skin, and blood samples for DNA markers.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0581
Date of REC Opinion
24 Apr 2015
REC opinion
Favourable Opinion