Treatment of Actinic Keratosis With 5% KOH Solution

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatologisches Zentrum, Bonn, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator

Time frame: Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary

Treatment success (yes, no) at the individual end-of-treatment visit (VE), defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator, which were present at V0 and treated with the investigational product (complete clearance).

Sponsors and collaborators

Lead sponsor

Infectopharm Arzneimittel GmbH

Industry

Collaborators

Gesellschaft für Therapieforschung mbH

Registry information

Official study 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)

Acronym: TAKKOH

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jul 18, 2019
Registry last updated: Oct 22, 2019

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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Completed