Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A phase III study to assess efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel 5%, applied once daily for 12 weeks in patients with acne vulgaris (GEDACNE-1)

This research study, called GEDACNE-1, is looking into a new gel treatment for acne. The gel, named N-Acetyl-GED-0507-34-Levo, is being tested at a 5% strength. Participants will apply the gel once daily for 12 weeks. The main goals are to find out how well the gel works in reducing different types of spots (like blackheads, whiteheads, and pimples) on the face, and to see if it makes the skin clearer overall. Researchers will also be carefully monitoring for any side effects to make sure the gel is safe. This is a Phase III study, which means it's one of the final steps before a new medicine might become available to the public.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

PPM Services S.A.

Enrolment target

300

Start

24 Sep 2024

acne vulgaris

What is this study about?

Acne is a common skin condition that causes spots, oily skin, and sometimes skin that is hot or painful to touch. This study is exploring a new gel treatment for acne, simply referred to here as 'the trial gel'. The aim is to see if this gel can help reduce acne spots and make skin clearer for people aged 18 and over.

Over 12 weeks, participants will use either the trial gel or a 'vehicle' gel, which looks and feels the same but doesn't contain the active ingredient. This helps researchers fairly compare how well the new treatment works. They will be looking closely at how many spots disappear and how much the skin improves in general. The study will also carefully track any side effects to ensure the gel is safe to use.

This type of study, called a Phase III trial, is a crucial step in developing new medicines. It means the treatment has already shown some promise in earlier stages, and now researchers need to confirm its effectiveness and safety in a larger group of people. If successful, this trial could lead to a new treatment option for people living with acne.

Key takeaways

Testing a new gel treatment for acne for people aged 18 and over.
The gel is applied once daily for 12 weeks.
Researchers will check how well the gel reduces spots and clears skin.
Safety is a top priority; side effects will be carefully monitored.
This is a late-stage study, aiming to confirm effectiveness and safety.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women are welcome to take part.

Beyond age and gender, specific medical conditions or previous treatments might affect whether you can join. These details will be discussed carefully with you by the study doctor to make sure the study is right and safe for you.

It's important to know that even if you meet the basic age requirement, other factors might mean you can't participate. The study team will explain everything fully to help you understand if you're a good fit.

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?
Do you have acne on your face?
Are you able to apply a gel to your face daily?
Are you able to attend regular study appointments for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll apply a gel to your skin once every day for 12 weeks. You won't know if you're getting the active treatment or a dummy gel, so the results are fair. You'll have several visits to the study clinic during these 12 weeks so the doctors can check your skin, count any spots, and make sure you're doing okay. They'll also ask you about how your skin is feeling and if you've noticed any changes, good or bad.

Each visit will involve detailed skin examinations, which might include photos of your face. You'll also be asked questions about your general health. It's important to attend all scheduled appointments and follow the instructions for applying the gel exactly as given.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment for acne before it's widely available, and close medical monitoring of your skin. However, there are also potential risks; you might experience side effects from the gel, or the treatment might not work for you. Using a dummy gel means your acne might not improve during the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Poland

Common questions

What kind of acne does this study look at?

This study is for people with common acne (acne vulgaris), which includes various types of spots like pimples, blackheads, and whiteheads.

How long will I need to use the gel?

You will need to apply the gel once a day for 12 weeks, which is about three months.

Will I know if I'm getting the actual study gel?

No, you won't know if you're getting the active gel or a dummy gel. This is standard in studies to ensure the results are unbiased and reliable.

What happens if my acne gets worse during the study?

The study team will closely monitor your skin. If your acne worsens significantly or you have concerns, they will discuss your options and provide appropriate care.

Will I have to pay to join this study?

No, participation in clinical trials does not usually require you to pay. All study-related treatments and visits are generally covered.