Clinical trial NCT04552327: 5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Solcera
Prospective
Multicentric
Monitored
Efficacy
Safety
Potassium Hydroxide
Randomized
Double-Blind
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2020-09-17
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment success
timeFrame: 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 outcomes:
measure: Treatment success
timeFrame: For Solaraze at day 90
measure: (Healing) status of AK lesions
timeFrame: 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)
measure: Overall number of AK lesions
timeFrame: 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)
measure: Mean size of AK lesions
timeFrame: 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)
measure: Treatment success
timeFrame: 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)
measure: Partial clearance
timeFrame: 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)
measure: Reduction of AK lesion number
timeFrame: 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)
measure: Clinical response
timeFrame: 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)
measure: Lesion-based treatment success (without consideration of relapses)
timeFrame: 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)
measure: Lesion-based treatment success (with consideration of relapses)
timeFrame: 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)
measure: Patients with relapse
timeFrame: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
measure: Lesions with relapse
timeFrame: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
measure: Efficacy assessment by physician
timeFrame: 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
measure: Efficacy assessment by patient
timeFrame: 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
measure: Tolerability assessment by physician
timeFrame: 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
measure: Tolerability assessment by patient
timeFrame: 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
measure: Overall assessment by physician
timeFrame: 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
measure: Overall assessment by patient
timeFrame: 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
measure: Adverse Events, Serious Adverse Events, Adverse Reactions
timeFrame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
measure: Dropouts
timeFrame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
measure: Compliance
timeFrame: 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
Other outcomes:
Locations:
city: Bad Soden
country: Germany
facility: Hautmedizin Bad Soden
city: Bonn
country: Germany
facility: MVZ - Dermatologisches Zentrum Bonn GmbH
city: Dülmen
country: Germany
facility: Proderma Studienzentrum
city: Falkensee
country: Germany
facility: Hautarztpraxis Falkensee
city: Freiburg
country: Germany
facility: Hautzentrum Südbaden
city: Hamm
country: Germany
facility: Hautarztzentrum Hamm
city: Hannover
country: Germany
facility: Praxis Dres. Med. Markus Kaspari und Florian Schenk
city: Heidelberg
country: Germany
facility: Durani Cosmetics GmbH
city: Ibbenbüren
country: Germany
facility: Hautarztpraxis Ibbenbüren
city: Köln
country: Germany
facility: Hautzentrum Köln
city: Lingen
country: Germany
facility: Praxis Dres. K.-H. Vehring/U. Amann
city: Mönchengladbach
country: Germany
facility: Zentderma GBR
city: Potsdam
country: Germany
facility: Haut- und Laserzentrum
city: Simmern
country: Germany
facility: Hautarztpraxis Asefi/Sadjadi
city: Stuttgart
country: Germany
facility: Hautarztpraxis Leitz und Kollegen
city: Vilshofen
country: Germany
facility: Hautarztpraxis Vilshofen
city: Wuppertal
country: Germany
facility: Centroderm GmbH
city: Wuppertal
country: Germany
facility: Hautzentrum Wuppertal
Study officials:
affiliation: MVZ - Dermatologisches Zentrum Bonn GmbH
name: Uwe Reinhold, Prof.
role: STUDY_DIRECTOR
References: