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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Actinic Keratoses
- Sponsor
- Infectopharm Arzneimittel GmbH
- Enrollment
- 73
- Locations
- 6
- Primary Endpoint
- Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
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).