NCT07137819

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

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients With Actinic Keratosis of the Scalp and the Face

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Aresus Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Participants type: Patients Age range: 18-64 years, 65+ years; male and female Locations: Germany

Conditions

• Actinic Keratosis of Face and Scalp

Interventions

Type	Name	Description
DRUG	Topical treatment	Self-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).

Timeline

• Start date: 2024-09-04
• Primary completion: 2026-03-01
• Completion: 2027-11-01
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Germany