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| Name | Class |
|---|---|
| Gesellschaft für Therapieforschung mbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solcera | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Solaraze | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solcera | Device | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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") | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | For Solaraze at day 90 |
| (Healing) status of AK lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Reinhold, Prof. | MVZ - Dermatologisches Zentrum Bonn GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hautmedizin Bad Soden | Bad Soden | 65812 | Germany | |||
| MVZ - Dermatologisches Zentrum Bonn GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40996107 | Derived | Reinhold U, Leitz N, Dominicus R, Szabo EL, Dirschka T, Popp G, Fischer TC, Adamini N, Ostendorf R, Asefi M, Durani H, Holting T, Amann U, Kreuziger F, Assmann T, Bruning H, Freitag L, Hoffmann K, Gedschold R. KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1050-1058. doi: 10.1111/jdv.70069. Epub 2025 Sep 25. |
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| Placebo | Device | 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) |
|
| Solaraze | Drug | Twice daily application for a duration of 60 days |
|
(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)) |
| 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) | 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) |
| 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) | 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)) | 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") | 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 | 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" | 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 | 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 | 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" | 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" | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 |
| Bonn |
| 53111 |
| Germany |
| Hautzentrum Köln | Cologne | 50996 | Germany |
| Proderma Studienzentrum | Dülmen | Germany |
| Hautarztpraxis Falkensee | Falkensee | 14612 | Germany |
| Hautzentrum Südbaden | Freiburg im Breisgau | Germany |
| Hautarztzentrum Hamm | Hamm | Germany |
| Praxis Dres. Med. Markus Kaspari und Florian Schenk | Hanover | 30159 | Germany |
| Durani Cosmetics GmbH | Heidelberg | Germany |
| Hautarztpraxis Ibbenbüren | Ibbenbueren | Germany |
| Praxis Dres. K.-H. Vehring/U. Amann | Lingen | 49809 | Germany |
| Zentderma GBR | Mönchengladbach | 41061 | Germany |
| Haut- und Laserzentrum | Potsdam | Germany |
| Hautarztpraxis Asefi/Sadjadi | Simmern | Germany |
| Hautarztpraxis Leitz und Kollegen | Stuttgart | Germany |
| Hautarztpraxis Vilshofen | Vilshofen | 94474 | Germany |
| Centroderm GmbH | Wuppertal | 42287 | Germany |
| Hautzentrum Wuppertal | Wuppertal | 42349 | Germany |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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