Treatment of Actinic Keratosis With 5% KOH Solution

NCT04024579 | Completed

• 1 other identifier: TAKKOH
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 6

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Infectopharm Arzneimittel GmbH: lead
• Gesellschaft für Therapieforschung mbH: collaborator

Study Sites (6)

Dermatologisches Zentrum

Bonn, 53111, Germany

Location

Hautzentrum Dülmen

Dülmen, 48249, Germany

Location

Hautärztliche Praxis

Friedrichshafen, 88045, Germany

Location

Hautzentrum Nymphenburg

München, 80639, Germany

Location

Haut- und Laserzentrum Potsdam

Potsdam, 14469, Germany

Location

Hautarzt-Praxis

Stuttgart, 70190, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dietrich Abeck, Prof.

  Professor of dermatology and allergology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: October 17, 2017
• Primary Completion: August 25, 2019
• Study Completion: August 25, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

DE (6)