Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Diclofenac

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

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)

Solcera

Placebo

Twice daily application for a duration of 60 days

Solaraze

Uwe Reinhold, Prof.

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.

5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis

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) (Regulated by the Laws for Both Medical Devices and Medicinal Products)

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")

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")

(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))

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)

Mean size of initial AK lesions identified at treatment start that have been treated with the investigational product (lesion size determined by largest diameter)

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))

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")

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

Clinical response, i.e. the number of patients with at least one AK lesion being assessed with "complete remission"

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

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

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"

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"

Assessment of the efficacy (scale based on school grades 1-6) by the treating physician

Assessment of the efficacy (scale based on school grades 1-6) by the patient

Assessment of the tolerability (scale based on school grades 1-6) by the treating physician

Assessment of the tolerability (scale based on school grades 1-6) by the patient

Overall assessment (scale based on school grades 1-6) by the treating physician

Overall assessment (scale based on school grades 1-6) by the patient

Number and frequency of Adverse Events, Serious Adverse Events and Adverse Reactions

All dropouts (incl. specification of reason and date)

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)

Spots Global Cancer Trial Database for potassium hydroxide