TY - JOUR
T1 - 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 A 2 inhibitor, AVX001, in participants with actinic keratosis
T2 - protocol for a randomised controlled phase I/IIa trial
AU - Ortner, Vinzent Kevin
AU - Johansen, Berit
AU - Kilov, Kim
AU - Castillo Mondragón, Alejandro
AU - Duvold, Tore
AU - Kihl, Jesper
AU - Ashcroft, Felicity J.
AU - Feuerherm, Astrid J.
AU - Pind Laugesen, Charlotte
AU - Marcker Espersen, Maiken Lise
AU - Manole, Ionela
AU - Isberg, Ari Pall
AU - Andersen, Anders Daniel
AU - Rakvaag, Elin
AU - Zibert, John R.
AU - Haedersdal, Merete
N1 - Funding Information:
This work is funded by Coegin Pharma AB.
PY - 2022
Y1 - 2022
N2 - Introduction Actinic keratosis (AK) is the most common precancerous skin condition caused by long-term UV exposure. Given the high recurrence rate of 15%-53%, identifying safe and effective treatment options is warranted. AVX001, a cytosolic phospholipase A 2 α (cPLA 2 α) enzyme inhibitor, is a novel anti-inflammatory drug for field-directed, self-administered, topical therapy of AK. Methods and analysis This study is a single-centre, randomised, vehicle-controlled, double-blind, parallel-group hybrid clinical trial in adults with multiple AK lesions Olsen grade 1 or 2. The hybrid design combines decentralised participant tasks and assessments with conventional in-clinic visits. Recruitment using targeted advertising on social media and eligibility prescreening are conducted via the Studies&Me online recruitment platform. Participants (n=60) are randomly assigned to 1 of 3 treatment arms: AVX001 gel 1%, AVX001 gel 3% or vehicle gel. The trial consists of a 4-week treatment period with daily field-directed topical application of the gel and an 8-week follow-up period. Participants attend in-clinic visits at baseline, week 4 and week 12. The remote participant trial tasks include questionnaires and upload of smartphone-obtained photos of the treated skin area using a study-specific web-based app. Both remote and in-clinic assessments of safety and efficacy will be performed. The primary objective is to evaluate the local tolerability of daily application of AVX001 gel (1% or 3%) compared with vehicle gel. Secondary objectives include safety, efficacy, dose-response efficacy relationship, treatment satisfaction and cosmetic outcome. Exploratory objectives include evaluations of tolerability and efficacy assessed by dermatologists using smartphone photos uploaded by participants, comparisons of in-clinic and remote assessments and assessment of AK-related skin changes by non-invasive optical imaging. Ethics and dissemination Approved by the Ethics Committee of the Capital Region of Denmark (H-21018064) and the Danish Medicines Agency (2021032485). Results will be submitted for publication in peer-reviewed scientific journals. Trial registration numbers 2021-000934-32; NCT05164393.
AB - Introduction Actinic keratosis (AK) is the most common precancerous skin condition caused by long-term UV exposure. Given the high recurrence rate of 15%-53%, identifying safe and effective treatment options is warranted. AVX001, a cytosolic phospholipase A 2 α (cPLA 2 α) enzyme inhibitor, is a novel anti-inflammatory drug for field-directed, self-administered, topical therapy of AK. Methods and analysis This study is a single-centre, randomised, vehicle-controlled, double-blind, parallel-group hybrid clinical trial in adults with multiple AK lesions Olsen grade 1 or 2. The hybrid design combines decentralised participant tasks and assessments with conventional in-clinic visits. Recruitment using targeted advertising on social media and eligibility prescreening are conducted via the Studies&Me online recruitment platform. Participants (n=60) are randomly assigned to 1 of 3 treatment arms: AVX001 gel 1%, AVX001 gel 3% or vehicle gel. The trial consists of a 4-week treatment period with daily field-directed topical application of the gel and an 8-week follow-up period. Participants attend in-clinic visits at baseline, week 4 and week 12. The remote participant trial tasks include questionnaires and upload of smartphone-obtained photos of the treated skin area using a study-specific web-based app. Both remote and in-clinic assessments of safety and efficacy will be performed. The primary objective is to evaluate the local tolerability of daily application of AVX001 gel (1% or 3%) compared with vehicle gel. Secondary objectives include safety, efficacy, dose-response efficacy relationship, treatment satisfaction and cosmetic outcome. Exploratory objectives include evaluations of tolerability and efficacy assessed by dermatologists using smartphone photos uploaded by participants, comparisons of in-clinic and remote assessments and assessment of AK-related skin changes by non-invasive optical imaging. Ethics and dissemination Approved by the Ethics Committee of the Capital Region of Denmark (H-21018064) and the Danish Medicines Agency (2021032485). Results will be submitted for publication in peer-reviewed scientific journals. Trial registration numbers 2021-000934-32; NCT05164393.
KW - adult dermatology
KW - adverse events
KW - clinical trials
KW - dermatological tumours
KW - dermatology
KW - protocols & guidelines
U2 - 10.1136/bmjopen-2022-061012
DO - 10.1136/bmjopen-2022-061012
M3 - Journal article
C2 - 36198452
AN - SCOPUS:85139287395
VL - 12
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 10
M1 - e061012
ER -