The goal of this clinical trial is to show superiority of Veregen® 10% ointment to Placebo measured by complete (100%) clearance of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks at most in patients without complete clearance at the end of the treatment (EoT) period).
Patients willing to participate, obtained written informed consent.
Male or female patients ≥ 18 years.
Clinically confirmed diagnosis of mild to moderate Actinic keratosis (AK) of the face including the forehead (excluding eyelids, lips and mucosa) and/or the bald scalp.
Presence of at least 4 but not more than 8 isolated (i.e. discrete and quantifiable) AK lesions located in a contiguous treatment area (TA) on the face and/or bald scalp of 25 square-cm.
TA is within 5 cm of an incompletely healed wound or infected area of the skin.
Patients not willing to abstain from sunbathing (including solarium) or any outdoor activities with intensive sun exposure without taking appropriate measures to protect the treatment areas during the study.
Patients with a tendency to manipulate skin parts e.g. scratching.
Pregnant or breast-feeding patients.
Parallel
Topical treatment
DrugSelf-treatment of patients with ointment of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks at most in patients without complete clearance at the end of the treatment (EoT) period).
Primary objective is to show superiority of Veregen® 10% ointment to Placebo measured by complete (100%) clearance of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period.
The primary objective of the study is to show superiority of Veregen® 10% ointment to Placebo measured by complete (100%) clearance of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks at most in patients without complete clearance at the end of the treatment (EoT) period).
Click on the lead sponsor to view all of their trials.
