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

NCT ID: NCT04552327

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 631 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2023-01-24

Brief Summary

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Solcera

Group Type: EXPERIMENTAL

Solcera

Intervention Type: 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)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Solaraze

Intervention Type: DRUG

Twice daily application for a duration of 60 days

Interventions

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)

Intervention Type: 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)

Intervention Type: DEVICE

Solaraze

Twice daily application for a duration of 60 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gesellschaft für Therapieforschung mbH

INDUSTRY

Sponsor Role: collaborator

Infectopharm Arzneimittel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Reinhold, Prof.

Role: STUDY_DIRECTOR

MVZ - Dermatologisches Zentrum Bonn GmbH

Locations

Hautmedizin Bad Soden

Bad Soden, , Germany

MVZ - Dermatologisches Zentrum Bonn GmbH

Bonn, , Germany

Hautzentrum Köln

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

Praxis Dres. K.-H. Vehring/U. Amann

Lingen, , Germany

Zentderma GBR

Mönchengladbach, , Germany

Haut- und Laserzentrum

Potsdam, , Germany

Hautarztpraxis Asefi/Sadjadi

Simmern, , Germany

Hautarztpraxis Leitz und Kollegen

Stuttgart, , Germany

Hautarztpraxis Vilshofen

Vilshofen, , Germany

Centroderm GmbH

Wuppertal, , Germany

Hautzentrum Wuppertal

Wuppertal, , Germany

Countries

Germany

References

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. 2025 Sep 25. doi: 10.1111/jdv.70069. Online ahead of print.

Reference Type: DERIVED

PMID: 40996107 (View on PubMed)

Other Identifiers

KOHDIAK

Identifier Type: -

Identifier Source: org_study_id