RecruitingPHASE3INTERVENTIONAL

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

This research is looking at a new herbal cream, Veregen® 10%, for treating sun-damaged patches on the skin called actinic keratosis, which often appear on the face and scalp. We want to find out if this cream is more effective than a placebo (a cream without active ingredients) at completely clearing these patches. The study will last about 16 weeks, including a 12-week treatment period and a 4-week follow-up. Participants will be aged 18 or over and have mild to moderate actinic keratosis. The main goal is to see if more people using the Veregen® 10% cream achieve a full clearance of their skin patches compared to those using the placebo.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Aresus Pharma GmbH

Enrolment target

280

Start

04 Sep 2024

Estimated completion

01 Nov 2027

Actinic Keratosis of Face and Scalp

What is this study about?

This clinical trial is exploring a potential new treatment for a common skin condition called actinic keratosis. These are rough, scaly patches that develop on skin regularly exposed to the sun, like the face and scalp. While often harmless, some can develop into skin cancer, so treating them is important. This study is testing a herbal cream called Veregen® 10% to see if it can effectively clear these patches.

The main aim is to discover if Veregen® 10% cream is better than a 'placebo' cream (a cream that looks the same but contains no active medicine) at making these patches disappear completely. By comparing the two, researchers can understand the true effect of the herbal cream. This kind of study helps doctors find the best and safest treatments for patients in the future.

This is a 'Phase 3' trial, which means the treatment has already gone through earlier safety checks and is now being tested on a larger group of people to confirm its effectiveness and compare it with existing options. The results will help determine if Veregen® 10% could become a new option for people with actinic keratosis.

Key takeaways

This study tests a new herbal cream for sun-damaged skin patches.
It aims to see if the cream can completely clear these patches.
Participation involves applying cream for 12 weeks and follow-up for 4 weeks.
You will either receive the active cream or a dummy cream (placebo).
It could offer a new treatment option for actinic keratosis.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have received a clear diagnosis of mild to moderate actinic keratosis (those rough patches from sun damage) on your face or bald scalp. These patches should be clearly separate and measurable, numbering between 4 and 8 in a specific area of about 25 square centimetres. You also need to be able to follow the study instructions carefully.

There are several reasons why you might not be able to take part. For example, if you are pregnant or breastfeeding, or if you have an unhealed wound or infection near the treatment area. You also can't join if you're taking part in another clinical study or if you have severe forms of actinic keratosis or patches that haven't responded to previous treatments like cryotherapy. It's also important to be willing to protect your skin from the sun during the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with mild to moderate actinic keratosis on your face or bald scalp?
Do you have between 4 and 8 clear, separate patches in one area?
Are you able to avoid intense sun exposure on the treated areas during the study?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will apply either the Veregen® 10% ointment or a placebo cream to your skin patches for about 12 weeks. During this time, you'll have regular check-ups with the study team to see how your skin is responding and to monitor any side effects. After the 12 weeks of treatment, there will be a follow-up period of about 4 weeks to see if the patches remain clear. The total time you'd be involved in the study, including treatment and follow-up, would be a maximum of 16 weeks. You would also need to avoid intense sun exposure on the treated areas throughout the study.

Potential risks and benefits

Taking part in this study could potentially lead to your actinic keratosis patches clearing up, improving your skin's health. However, as with any medication, there's a chance of side effects, such as skin irritation, redness, or itching from the cream. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Aresus Pharma GmbH
Verified postcode
Strausberg, Germany· Recruiting

Common questions

What is actinic keratosis?

It's a common skin condition caused by too much sun exposure. It appears as rough, scaly, or crusty patches, usually on areas of skin that get a lot of sun.

What is Veregen® 10% ointment?

It's a herbal cream being tested as a new topical (applied to the skin) treatment for actinic keratosis.

What does 'placebo' mean?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers compare the true effects of the active medicine.

How long will the study last?

The study will involve a treatment period of 12 weeks, followed by a 4-week check-up period, making the total involvement up to 16 weeks.

Where is this study taking place?

This study is being conducted in research centres across Germany.

How to find out more

Sven Schimansky-Wabra, Managing Director

exact-1@aresus.de 004933415899040 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.