Status:
COMPLETED
Treatment of Actinic Keratosis With 5% KOH Solution
Lead Sponsor:
Infectopharm Arzneimittel GmbH
Collaborating Sponsors:
Gesellschaft für Therapieforschung mbH
Conditions:
Actinic Keratoses
Eligibility:
All Genders
30-80 years
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 tota...
Eligibility Criteria
Inclusion
- Written informed consent
- Age: 30 to 80 years
- Adults with AK grade I (mild) or II (moderate)
Exclusion
- 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
Key Trial Info
Start Date :
October 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2019
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04024579
Start Date
October 17 2017
End Date
August 25 2019
Last Update
October 22 2019
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatologisches Zentrum
Bonn, Germany, 53111
2
Hautzentrum Dülmen
Dülmen, Germany, 48249
3
Hautärztliche Praxis
Friedrichshafen, Germany, 88045
4
Hautzentrum Nymphenburg
München, Germany, 80639