The COAK study: Phase I / II study in actinic keratosis
The COAK study was a double-blind, placebo-controlled, combined phase I / II study conducted with a decentralized approach, based on digital tools designed to put the patient at the center. The patients received guidance and support at a distance and were given the opportunity to report from home to the hospital, which reduced the number of physical visits to the hospital. The study was conducted at Bispebjerg Hospital in Copenhagen in collaboration with Studies & Me, a CRO specializing in decentralized clinical studies.
The study included 60 patients, divided into three groups, with two different doses of AVX001 (1% and 3%) and placebo through a cosmetically attractive gel formulation. The patients themselves have administered the treatment once daily for four weeks. To evaluate safety and tolerance, patients were followed up eight weeks after the end of treatment. The primary objectives of the study were to evaluate safety, tolerance while secondary objectives included efficiency and quality of life.
Results from the COAK study
The primary study objective of the COAK study was to investigate local skin reactions during treatment with AVX001 gel and here the outcome showed that treatment with AVX001 gel is safe and well tolerated. None of the 60 patients included in the study experienced any adverse events. Two patients out of 60 experienced mild to moderate local skin reactions that disappeared after treatment. Most of the patients were treated on the face (44 out of 60) and these patients did not experience any local skin reactions. The two patients who experienced transient local skin reactions were treated with 3% AVX001 gel on the chest.
The COAK study was not designed and statistically designed to draw definite conclusions about effect. Nevertheless, the secondary targets show that 15% of the patients treated with active doses achieved clearance (ie more than 50% reduction in actinic keratosis lesions). However, due to the low number of patients, these results are not statistically significant. In addition, 74% of patients treated with 3% AVx001 gel achieved an improvement in their AK lesions. The results thus show a clear tendency to effect.