Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis (NCT07137819) | Clinical Trial Compass
RecruitingPhase 3
Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
Germany280 participantsStarted 2024-09-04
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* 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.
* AK lesions of the TA must be clinically typical AK lesions of Olsen grade I and/or grade Olsen grade II.
* Ability to follow study instructions and likely to complete all study requirements.
Exclusion Criteria:
* 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.
* Patients currently or within the past 4 weeks participating in another clinical study.
* Any previous randomization into this clinical study.
* Any suspicion of current drug and/or alcohol abuse.
* Patient is institutionalized because of legal or regulatory order.
* Dependency (as an employee or relative) to the sponsor/responsible CRO or investigator.
* Any condition that in the opinion of …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: From enrollment to the end of treatment period at 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks).