The KOHDIAK study is a prospective, three-armed, randomised, double-blind study to evaluate the efficacy and safety of the treatment of mild and moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo and investigator-blinded comparison with 3% diclofenac gel (Solaraze, medicinal product). It is performed in accordance with both the laws in force for clinical trials with medical devices and those with medicinal products.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
631
Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
Twice daily application for a duration of 60 days
Hautmedizin Bad Soden
Bad Soden, Germany
MVZ - Dermatologisches Zentrum Bonn GmbH
Bonn, Germany
Hautzentrum Köln
Treatment success
Treatment success, defined as complete, dermatoscopically confirmed remission of all initial actinic keratosis (AK) lesions identified at treatment start that have been treated with the investigational product ("Complete Clearance")
Time frame: At the control visit at the end of treatment ("EOT", i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)
Treatment success
Treatment success, defined as complete, dermatoscopically confirmed remission of all initial AK lesions identified at treatment start that have been treated with the investigational product ("Complete Clearance")
Time frame: For Solaraze at day 90
(Healing) status of AK lesions
(Healing) status of AK lesions (number of proliferating lesions, unchanged/stable lesions, lesions being in remission or showing partial remission, lesions with complete remission, and relapses; overall and grouped by localisation and size (0-5 mm, 6-10 mm, 11-15 mm, 16-20 mm)); analysed for a) initial AK lesions identified at treatment start that have been treated with the investigational product, b) new AK lesions appearing in the treated area after treatment start, c) all AK lesions (i.e. a) + b))
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Overall number of AK lesions
Overall number of initial AK lesions identified at treatment start that have been treated with the investigational product (i.e. without AK lesions with complete remission)
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
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Cologne, Germany
Proderma Studienzentrum
Dülmen, Germany
Hautarztpraxis Falkensee
Falkensee, Germany
Hautzentrum Südbaden
Freiburg im Breisgau, Germany
Hautarztzentrum Hamm
Hamm, Germany
Praxis Dres. Med. Markus Kaspari und Florian Schenk
Hanover, Germany
Durani Cosmetics GmbH
Heidelberg, Germany
Hautarztpraxis Ibbenbüren
Ibbenbueren, Germany
...and 8 more locations
Mean size of AK lesions
Mean size of initial AK lesions identified at treatment start that have been treated with the investigational product (lesion size determined by largest diameter)
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Treatment success
Treatment success (complete, dermatoscopically confirmed remission of lesions) analysed for a) initial AK lesions identified at treatment start that have been treated with the investigational product, b) new AK lesions appearing in the treated area after treatment start, c) all AK lesions (i.e. a) + b))
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Partial clearance
Number of patients with "partial clearance" (i.e. all patients with at least 75% of the initial AK lesions identified at treatment start being assessed with "complete remission")
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Reduction of AK lesion number
Reduction of AK lesion number per patient (in % compared to the number of initial AK lesions identified at treatment start) analysed for initial AK lesions identified at treatment start that have been treated with the investigational product
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Clinical response
Clinical response, i.e. the number of patients with at least one AK lesion being assessed with "complete remission"
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Lesion-based treatment success (without consideration of relapses)
Number of initial AK lesions identified at treatment start that have been treated with the investigational product, which showed "complete remission" at least once between treatment start and EOT
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Lesion-based treatment success (with consideration of relapses)
Number of initial AK lesions identified at treatment start that have been treated with the investigational product, which showed "complete remission" at the respectively analysed visit
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Patients with relapse
Number of patients with at least one initial AK lesion being assessed as "relapse" after previous "Complete Clearance" (definition see above), analysed for the time period between treatment start and the follow-up visit after 24 weeks and analysed in reference to a) the number of all patients and b) the number of those patients with previous "Complete Clearance"
Time frame: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
Lesions with relapse
Number of initial AK lesions being assessed as "relapse", analysed for the time period between treatment start and the follow-up visit after 24 weeks and analysed in reference to a) the number of all initial lesions and b) the number of those initial lesions with previous "complete remission"
Time frame: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
Efficacy assessment by physician
Assessment of the efficacy (scale based on school grades 1-6) by the treating physician
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Efficacy assessment by patient
Assessment of the efficacy (scale based on school grades 1-6) by the patient
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Tolerability assessment by physician
Assessment of the tolerability (scale based on school grades 1-6) by the treating physician
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Tolerability assessment by patient
Assessment of the tolerability (scale based on school grades 1-6) by the patient
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Overall assessment by physician
Overall assessment (scale based on school grades 1-6) by the treating physician
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Overall assessment by patient
Overall assessment (scale based on school grades 1-6) by the patient
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Adverse Events, Serious Adverse Events, Adverse Reactions
Number and frequency of Adverse Events, Serious Adverse Events and Adverse Reactions
Time frame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Dropouts
All dropouts (incl. specification of reason and date)
Time frame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Compliance
Compliance of the patients with the application schedule of the respective investigational product (based on entries in the patient diary and only overruled by the weight of returned investigational products in case of clear discrepancies)
Time frame: Analysed for the respective time period of scheduled product application, i.e. Day 0 until Day 60 for Solaraze and 1-3x 28 days (depeding on number of cycles) for Solcera/Placebo