Decentralized clinical trial for treatment of skin cancer precursor lesions
Virtual recruitment and remote assessments can help modernize clinical cancer research.
A novel topical drug shows potential to develop into a self-administered treatment for actinic keratosis. Non-invasive optical imaging can be used for the evaluation of treatment response and adverse events.
In collaboration with Studies&Me, we aim to improve the management of patients suffering from actinic sun damage. By using a virtual recruitment strategy and remote monitoring, this clinical trial allow prospective participants to topically treat their photodamaged skin with a new drug from the comfort of their own home. In a hybrid setting consisting of smartphone-based remote monitoring and on-site visits for clinical assessments and non-invasive imaging, we ensure patient safety without overburdening participants with needless hospital visits. By scanning treatment areas with our imaging equipment, including optical coherence tomography, we hope to be able to extract a set of digital image biomarkers that can help us detect early treatment response and potential adverse reactions.
Researcher
Vinzent Kevin Ortner, MD
Project supervisors
Merete Hædersdal, Professor, MD, DMSc, PhD
John Robert Zibert, BSc, MSc, PhD
Project period
2021-2023
Project collaborators
Studies&Me, Coegin Pharma
Financing
External funding
Press release
Selected publications
Ortner VK, Johansen B, Kilov K, Castillo Mondragón A, Duvold T, Kihl J, Ashcroft FJ, Feuerherm AJ, Pind Laugesen C, Marcker Espersen ML, Manole I, Isberg AP, Andersen AD, Rakvaag E, Zibert JR, Haedersdal M. The Copenhagen Actinic Keratosis Study (COAKS). A decentralised clinical trial to evaluate tolerability, safety and efficacy of daily field-directed topical treatment with cytosolic phospholipase A2 inhibitor, AVX001, in participants with actinic keratosis: protocol for a randomised controlled phase I/IIa trial. BMJ Open. 2022 Oct 5;12(10):e061012.
Ashcroft FJ, Mahammad N, Midtun Flatekvål H, Jullumstrø Feuerherm A, Johansen B. cPLA2α Enzyme Inhibition Attenuates Inflammation and Keratinocyte Proliferation. Biomolecules. 2020 Oct 2;10(10):1402.
Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Nov 4;22(11):e22179.
Hendel K, Mogensen M, Wenande E, Dierickx C, Haedersdal M, Togsverd-Bo K. Fractional 1,927 nm Thulium Laser Plus Photodynamic Therapy Compared and Combined for Photodamaged Décolleté Skin: A Side-by-Side Randomized Controlled Trial. Lasers Surg Med. 2020 Jan;52(1):44-52.