Title

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)
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Recruiting
  • Intervention/Treatment

    Solaraze ...
  • Study Participants

    630
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 Started
Oct 14
2020
Primary Completion
Sep 30
2023
Anticipated
Study Completion
Sep 30
2023
Anticipated
Last Update
Nov 02
2021

Device Solcera

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)

Device Placebo

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)

Drug Solaraze

Twice daily application for a duration of 60 days

Solcera Experimental

Placebo Placebo Comparator

Solaraze Active Comparator

Criteria

Inclusion Criteria:

Age ≥ 18 years and < 90 years
Actinic keratosis grade I (mild) or II (moderate) according to the definition by Olsen with palpable or clinically/dermatoscopically apparent keratosis
Either lesions being well accessible/treatable by the patient or presence of a second person to do the daily applications
Written informed consent by the patient

Exclusion Criteria:

Number of initial lesions to be treated ≥ 6
Overall size of the area to be treated > 25 cm2
Size (maximum diameter) of single lesion to be treated > 20 mm
Lesions in close proximity to the eyes, eyelids, nostrils, mouth or mucosal tissue
Need for topical treatment of cancerous area
Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
Existing skin cancer (all forms of skin cancer incl. basal-cell carcinoma and squamous cell carcinoma) in the area to be treated in this study
Dermal injuries, skin infection or exfoliative dermatitis in the area to be treated in this study
Other skin diseases in the area to be treated in this study that affect the diagnostic assessment
Pharmacological or physical local therapy of actinic keratosis (or application of the active ingredients used in the pharmacological therapy) in the area to be treated in this study during the last 4 weeks
Primary or secondary immunodeficiency
Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks
Treatment with oral isotretinoin during the last 6 months
Intracranial bleeding in the medical history or generally increased primary bleeding tendency
Known intolerance/hypersensitivity to one of the ingredients of the investigational products, especially to diclofenac, parabens or benzyl alcohol as well as to NSAIDs, in particular acetylsalicylic acid
Pregnancy and lactation
Women of child-bearing potential either wishing to become pregnant or without effective contraception
Other serious diseases, which are (according to the investigator's assessment) in conflict with the study participation (i.a. also in view of risk factors for a severe course of a potential COVID-19 disease in case of a SARS-CoV-2 infection)
Obvious unreliability or lack of cooperation
Known addiction to alcohol, medicinal products or drugs
Dependency on the sponsor or an investigator
Participation in a clinical trial during the last 30 days
Previous participation in the present clinical trial
Participation of a family member (in the same household) in the present clinical trial
No Results Posted