Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis

Recruiting Phase 3 Interventional Study
Actinic Keratosis of Face and Scalp
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
280 (estimated)
Sponsor
Aresus Pharma GmbH · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. …
Contacts

Sven Schimansky-Wabra, Managing Director

004933415899040

exact-1@aresus.de

CONTACT