Clinical trial NCT04024579: Treatment of Actinic Keratosis With 5% KOH Solution
Official title: Prospective, Single-arm, Medical Device Investigation According to § 23b MPG [German Medical Devices Act] on Efficacy and Safety of Treatment of Actinic Keratosis With a 5% Potassium Hydroxide Solution (AKOHDerm)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratoses
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2019-07-18
Enrollment: 73
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of the participating study sites (medical practice and experienced in the management and treatment of patients suffering from the disease as mentioned in the inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the TAKKOH study

Brief summary: This is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution.

In total, 68 patients with actinic keratosis grade I/II, who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated twice daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days.

The primary objective is treatment success at the individual end-of-treatment visit of all AK lesions present at baseline and treated with the investigational product.

Beside this, adverse events will be collected at each visit and evaluated in order to investigate clinical safety.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age: 30 to 80 years
* Adults with AK grade I (mild) or II (moderate)

Exclusion Criteria:

* Number of lesions requiring treatment \> 10
* Lesion to be treated \> 20 mm (maximum diameter)
* Lesions directly adjoining to the eyes, eyelids, nostrils, mouth or mucosal tissue,
* Need for topical treatment of a cancerous area
* Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
* Presence of a persistent or relapsing lesion despite appropriate treatment with AKOHDerm or another appropriate treatment
* High risk of progression of AK according as assessed by a medical doctor
* Pharmacological or physical local therapy of AK in the area foreseen for treatment dur-ing the last 12 weeks
* Treatment with systemic corticosteroids during the last 2 weeks
* Planned concomitant treatment of the same AK lesions during the study in addition to study treatment
* Other skin diseases in the area of application which might interfere with clinical signs
* Known predisposition for hypertrophic scarring / keloidosis
* Primary or secondary immunodeficiency
* Treatment with interferons, interferon inducers or immunomodulators during the last 4 weeks
* Pregnancy and lactation
* No reliable contraception in women of child-bearing potential
* Other serious diseases which are according to the investigator in conflict with the par-ticipation
* Obvious unreliability or lack of cooperation - known addiction to alcohol, medicinal products or drugs
* Dependent relationship with sponsor or investigator
* Participation in a clinical trial within the last 30 days
* Previous participation in this study

Primary outcomes:
measure: Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator
timeFrame: Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dermatologisches Zentrum
city: Dülmen
country: Germany
facility: Hautzentrum Dülmen
city: Friedrichshafen
country: Germany
facility: Hautärztliche Praxis
city: München
country: Germany
facility: Hautzentrum Nymphenburg
city: Potsdam
country: Germany
facility: Haut- und Laserzentrum Potsdam
city: Stuttgart
country: Germany
facility: Hautarzt-Praxis
Study officials:
affiliation: Professor of dermatology and allergology
name: Dietrich Abeck, Prof.
role: PRINCIPAL_INVESTIGATOR
References: