Treatment of Actinic Keratosis With 5% KOH Solution

Actinic Keratoses Clinical Trial

— TAKKOH  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024579
• Other study ID #: TAKKOH
• Status: Completed
• Start date: October 17, 2017
• Est. completion date: August 25, 2019

Study information

• Verified date: October 2019
• Source: Infectopharm Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 25, 2019
• Est. primary completion date: August 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Locations

Country	Name	City	State
Germany	Dermatologisches Zentrum	Bonn
Germany	Hautzentrum Dülmen	Dülmen
Germany	Hautärztliche Praxis	Friedrichshafen
Germany	Hautzentrum Nymphenburg	München
Germany	Haut- und Laserzentrum Potsdam	Potsdam
Germany	Hautarzt-Praxis	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
Infectopharm Arzneimittel GmbH	Gesellschaft für Therapieforschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator	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).	Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary