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Completed

NCT Number: NCT04552327

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

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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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hautmedizin Bad Soden, Bad Soden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

Primary outcomes

  1. Treatment success

    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, 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")

Secondary outcomes

  1. Treatment success

    Time frame: For Solaraze at day 90

    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")

  2. (Healing) status of AK lesions

    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)

    (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))

  3. Overall number of AK lesions

    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 initial AK lesions identified at treatment start that have been treated with the investigational product (i.e. without AK lesions with complete remission)

  4. Mean size of AK lesions

    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)

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

  5. Treatment success

    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 (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))

  6. Partial clearance

    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)

    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")

  7. Reduction of AK lesion number

    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 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

  8. Clinical response

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

  9. Lesion-based treatment success (without consideration of relapses)

    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)

    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

  10. Lesion-based treatment success (with consideration of relapses)

    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)

    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

  11. Patients with relapse

    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

    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"

  12. Lesions with relapse

    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

    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"

  13. Efficacy assessment by 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

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

  14. Efficacy assessment by 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

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

  15. Tolerability assessment by 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

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

  16. Tolerability assessment by 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

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

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

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

  19. Adverse Events, Serious Adverse Events, Adverse Reactions

    Time frame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)

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

  20. Dropouts

    Time frame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)

    All dropouts (incl. specification of reason and date)

  21. Compliance

    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

    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)

Sponsors and collaborators

Lead sponsor

Infectopharm Arzneimittel GmbH

Industry

Collaborators

  • Gesellschaft für Therapieforschung mbH

Registry information

Official study title

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)

Acronym: KOHDIAK

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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