Actively Recruiting
Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
Led by Aresus Pharma GmbH · Updated on 2025-08-22
280
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to participate and provide written informed consent
- Male or female aged 18 years or older
- Clinically confirmed mild to moderate actinic keratosis of the face (including forehead) and/or bald scalp
- Presence of 4 to 8 isolated actinic keratosis lesions in a contiguous 25 cm8 treatment area
- Lesions must be Olsen grade I or II
- Ability to follow study instructions and likely to complete all study requirements
You will not qualify if you...
- Treatment area within 5 cm of an incompletely healed wound or infected skin area
- Unwillingness to avoid sunbathing or intense sun exposure without protection during study
- Tendency to scratch or manipulate skin in treatment area
- Pregnant or breastfeeding
- Participation in another clinical study within past 4 weeks
- Prior randomization in this study
- Suspected current drug or alcohol abuse
- Institutionalized due to legal or regulatory order
- Dependency on sponsor, CRO, or investigator
- Conditions affecting treatment evaluation
- Allergy or intolerance to Veregen4 ointment or placebo ingredients
- Treatment area contains atypical or severe lesions (Olsen grade III), recalcitrant lesions, cutaneous horns, or lesions unresponsive to two prior cryotherapies
- Recent topical or physical treatments in the area within specified time frames (12, 6, or 4 weeks depending on treatment type)
- Initiation of certain systemic treatments within 2 weeks before baseline
- Current or planned use of high-dose oral green tea or astringent dermal preparations on treatment area
- Use of drugs with potential skin reactions unless stable dose for 2 weeks
- Women of childbearing potential not using highly effective contraception during study and 4 weeks post-treatment
- Suspicion of other malignant or benign skin tumors in treatment area
- History of genetic skin cancer disorders or invasive tumors in treatment area
- Other skin conditions interfering with study evaluation
- Significant physical abnormalities in treatment area affecting assessment
- Clinically significant or unstable medical conditions
- Unwillingness to stop use of certain skincare products and makeup in treatment area during study
- Unwillingness to avoid makeup and sunscreen use within 12 hours before on-site visits during follow-up period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aresus Pharma GmbH
Strausberg, Germany
Actively Recruiting
Research Team
S
Sven Schimansky-Wabra, Managing Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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