Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

Summary

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer. The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

Timeline

Start

2021-11-02

Primary completion

2022-03

Completion

2022-03

Outcome

Met primary endpoint

release “The COAK study findings clearly demonstrate that treatment with AVX001 is both safe and well tolerated. Thus, the study has achieved its primary objectives.” coeginpharma.com ↗

Publications

• Ortner VK, Johansen B, Kilov K, Castillo Mondragon 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. doi: 10.1136/bmjopen-2022-061012.

Drugs

Indications