Back to results5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis (KOHDIAK)
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Solcera
Placebo
Solaraze
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Solcera, Prospective, Multicentric, Monitored, Efficacy, Safety, Potassium Hydroxide, Randomized, Double-Blind
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
Sites / Locations
- Hautmedizin Bad Soden
- MVZ - Dermatologisches Zentrum Bonn GmbH
- Proderma Studienzentrum
- Hautarztpraxis Falkensee
- Hautzentrum Südbaden
- Hautarztzentrum Hamm
- Praxis Dres. Med. Markus Kaspari und Florian Schenk
- Durani Cosmetics GmbH
- Hautarztpraxis Ibbenbüren
- Hautzentrum Köln
- Praxis Dres. K.-H. Vehring/U. Amann
- Zentderma GBR
- Haut- und Laserzentrum
- Hautarztpraxis Asefi/Sadjadi
- Hautarztpraxis Leitz und Kollegen
- Hautarztpraxis Vilshofen
- Centroderm GmbH
- Hautzentrum Wuppertal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Solcera
Placebo
Solaraze
Arm Description
Outcomes
Primary Outcome Measures
Treatment success
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 Outcome Measures
Treatment success
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
(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 AK lesions
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 AK lesions
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
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))
Partial clearance
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
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
Clinical response, i.e. the number of patients with at least one AK lesion being assessed with "complete remission"
Lesion-based treatment success (without consideration of relapses)
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
Lesion-based treatment success (with consideration of relapses)
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
Patients with relapse
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"
Lesions with relapse
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"
Efficacy assessment by physician
Assessment of the efficacy (scale based on school grades 1-6) by the treating physician
Efficacy assessment by patient
Assessment of the efficacy (scale based on school grades 1-6) by the patient
Tolerability assessment by physician
Assessment of the tolerability (scale based on school grades 1-6) by the treating physician
Tolerability assessment by patient
Assessment of the tolerability (scale based on school grades 1-6) by the patient
Overall assessment by physician
Overall assessment (scale based on school grades 1-6) by the treating physician
Overall assessment by patient
Overall assessment (scale based on school grades 1-6) by the patient
Adverse Events, Serious Adverse Events, Adverse Reactions
Number and frequency of Adverse Events, Serious Adverse Events and Adverse Reactions
Dropouts
All dropouts (incl. specification of reason and date)
Compliance
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)
Full Information
NCT ID
NCT04552327
First Posted
September 3, 2020
Last Updated
February 28, 2023
Sponsor
Infectopharm Arzneimittel GmbH
Collaborators
Gesellschaft für Therapieforschung mbH
1. Study Identification
Unique Protocol Identification Number
NCT04552327
Brief Title
5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis
Acronym
KOHDIAK
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infectopharm Arzneimittel GmbH
Collaborators
Gesellschaft für Therapieforschung mbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, Solcera, Prospective, Multicentric, Monitored, Efficacy, Safety, Potassium Hydroxide, Randomized, Double-Blind
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
631 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solcera
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Solaraze
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Solcera
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Drug
Intervention Name(s)
Solaraze
Intervention Description
Twice daily application for a duration of 60 days
Primary Outcome Measure Information:
Title
Treatment success
Description
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")
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)
Secondary Outcome Measure Information:
Title
Treatment success
Description
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")
Time Frame
For Solaraze at day 90
Title
(Healing) status of AK lesions
Description
(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))
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)
Title
Overall number of AK lesions
Description
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)
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)
Title
Mean size of AK lesions
Description
Mean size of initial AK lesions identified at treatment start that have been treated with the investigational product (lesion size determined by largest diameter)
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)
Title
Treatment success
Description
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))
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)
Title
Partial clearance
Description
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")
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)
Title
Reduction of AK lesion number
Description
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
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)
Title
Clinical response
Description
Clinical response, i.e. the number of patients with at least one AK lesion being assessed with "complete remission"
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)
Title
Lesion-based treatment success (without consideration of relapses)
Description
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
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)
Title
Lesion-based treatment success (with consideration of relapses)
Description
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
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)
Title
Patients with relapse
Description
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"
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
Title
Lesions with relapse
Description
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"
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
Title
Efficacy assessment by physician
Description
Assessment of the efficacy (scale based on school grades 1-6) by the treating 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
Title
Efficacy assessment by patient
Description
Assessment of the efficacy (scale based on school grades 1-6) by the 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
Title
Tolerability assessment by physician
Description
Assessment of the tolerability (scale based on school grades 1-6) by the treating 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
Title
Tolerability assessment by patient
Description
Assessment of the tolerability (scale based on school grades 1-6) by the 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
Title
Overall assessment by physician
Description
Overall assessment (scale based on school grades 1-6) by the treating 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
Title
Overall assessment by patient
Description
Overall assessment (scale based on school grades 1-6) by the 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
Title
Adverse Events, Serious Adverse Events, Adverse Reactions
Description
Number and frequency of Adverse Events, Serious Adverse Events and Adverse Reactions
Time Frame
In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Title
Dropouts
Description
All dropouts (incl. specification of reason and date)
Time Frame
In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Title
Compliance
Description
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)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Reinhold, Prof.
Organizational Affiliation
MVZ - Dermatologisches Zentrum Bonn GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Hautmedizin Bad Soden
City
Bad Soden
ZIP/Postal Code
65812
Country
Germany
Facility Name
MVZ - Dermatologisches Zentrum Bonn GmbH
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Proderma Studienzentrum
City
Dülmen
Country
Germany
Facility Name
Hautarztpraxis Falkensee
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Hautzentrum Südbaden
City
Freiburg
Country
Germany
Facility Name
Hautarztzentrum Hamm
City
Hamm
Country
Germany
Facility Name
Praxis Dres. Med. Markus Kaspari und Florian Schenk
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Durani Cosmetics GmbH
City
Heidelberg
Country
Germany
Facility Name
Hautarztpraxis Ibbenbüren
City
Ibbenbüren
Country
Germany
Facility Name
Hautzentrum Köln
City
Köln
ZIP/Postal Code
50996
Country
Germany
Facility Name
Praxis Dres. K.-H. Vehring/U. Amann
City
Lingen
ZIP/Postal Code
49809
Country
Germany
Facility Name
Zentderma GBR
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Haut- und Laserzentrum
City
Potsdam
Country
Germany
Facility Name
Hautarztpraxis Asefi/Sadjadi
City
Simmern
Country
Germany
Facility Name
Hautarztpraxis Leitz und Kollegen
City
Stuttgart
Country
Germany
Facility Name
Hautarztpraxis Vilshofen
City
Vilshofen
ZIP/Postal Code
94474
Country
Germany
Facility Name
Centroderm GmbH
City
Wuppertal
ZIP/Postal Code
42287
Country
Germany
Facility Name
Hautzentrum Wuppertal
City
Wuppertal
ZIP/Postal Code
42349
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis
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