Treatment of Actinic Keratosis With 5% KOH Solution

Launched by INFECTOPHARM ARZNEIMITTEL GMBH · Jul 17, 2019

Keywords

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Gender

ALL

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
• • 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