- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552327
5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis (KOHDIAK)
March 4, 2024 updated by: Infectopharm Arzneimittel GmbH
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)
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
631
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas Borrmann, Dr.
- Email: studien@infectopharm.com
Study Contact Backup
- Name: Katja Eifert
- Email: studien@infectopharm.com
Study Locations
-
-
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Bad Soden, Germany, 65812
- Hautmedizin Bad Soden
-
Bonn, Germany, 53111
- MVZ - Dermatologisches Zentrum Bonn GmbH
-
Dülmen, Germany
- Proderma Studienzentrum
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Falkensee, Germany, 14612
- Hautarztpraxis Falkensee
-
Freiburg, Germany
- Hautzentrum Südbaden
-
Hamm, Germany
- Hautarztzentrum Hamm
-
Hannover, Germany, 30159
- Praxis Dres. Med. Markus Kaspari und Florian Schenk
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Heidelberg, Germany
- Durani Cosmetics GmbH
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Ibbenbüren, Germany
- Hautarztpraxis Ibbenbüren
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Köln, Germany, 50996
- Hautzentrum Köln
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Lingen, Germany, 49809
- Praxis Dres. K.-H. Vehring/U. Amann
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Mönchengladbach, Germany, 41061
- Zentderma GBR
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Potsdam, Germany
- Haut- und Laserzentrum
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Simmern, Germany
- Hautarztpraxis Asefi/Sadjadi
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Stuttgart, Germany
- Hautarztpraxis Leitz und Kollegen
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Vilshofen, Germany, 94474
- Hautarztpraxis Vilshofen
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Wuppertal, Germany, 42287
- CentroDerm GmbH
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Wuppertal, Germany, 42349
- Hautzentrum Wuppertal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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)
|
Experimental: 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)
|
Active Comparator: Solaraze
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Twice daily application for a duration of 60 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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")
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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")
|
For Solaraze at day 90
|
(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))
|
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
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)
|
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
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)
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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
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))
|
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
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")
|
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
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
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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
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"
|
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)
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
|
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)
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
|
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
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"
|
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
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"
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
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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)
|
In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
|
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)
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Uwe Reinhold, Prof., MVZ - Dermatologisches Zentrum Bonn GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2020
Primary Completion (Actual)
January 24, 2023
Study Completion (Actual)
January 24, 2023
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 10, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Precancerous Conditions
- Keratosis, Actinic
- Keratosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- KOHDIAK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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