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-2)
Acne vulgaris is a very common skin condition that causes spots, redness, and inflammation. This phase III clinical trial tests an experimental gel called N-Acetyl-GED-0507-34-LEVO (5%). Researchers want to find out how safe the gel is and how well it clears acne over 12 weeks of daily use. Participants are split into two groups. One group applies the active treatment gel once a day, while the other applies a matching dummy gel with no active medicine, known as a vehicle gel. Doctors will count the number of spots on the face and trunk, and rate how clear the skin looks throughout the study. The main goal is to see if the new gel significantly reduces spots and improves skin appearance compared to the plain gel, helping doctors understand if this could become a helpful new acne treatment.
At a glance
What is this study about?
Acne is one of the most common skin conditions in the UK. It happens when hair follicles get clogged with oil and dead skin cells, leading to blackheads, whiteheads, and painful red spots. While many acne treatments exist, they do not work for everyone and can sometimes cause skin dryness or irritation. Because of this, scientists are always searching for gentler, more effective options.
This clinical study focuses on a new treatment gel called N-Acetyl-GED-0507-34-LEVO 5%. It is a Phase III study, which means earlier smaller studies have already tested the gel, and researchers now need to confirm whether it works well in a larger group of people. The study compares the medicated gel to a inactive 'vehicle' gel—a gel base that looks and feels the same but contains no active medicine.
Over the course of 12 weeks, researchers will carefully monitor participants to see whether the gel reduces the total number of spots on the face and upper body. They will also track whether people achieve 'clear' or 'almost clear' skin. By taking part, volunteers help medical researchers discover whether this new medicine could be a safe and practical option for people dealing with troublesome acne.
Key takeaways
- Tests a new 5% gel treatment applied once daily for 12 weeks.
- Aims to reduce spots and inflammation on the face and upper body.
- Compares the new gel against an inactive dummy gel to check how well it works.
- Requires regular clinic visits to count spots and monitor skin safety.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults who are dealing with acne vulgaris on their face and body. Both men and women can take part. While the study design evaluates outcomes for different age groups in its wider research plan, the main trial listing specifies an age of 18 years and older.
To join, volunteers must have an active acne breakout that doctors can count and assess. You will need to be willing to apply the study gel once every day to the affected areas for the full 12-week study period.
You might not be able to join if you are already using certain prescription acne treatments, oral antibiotics, or skin creams that could interfere with the study results. The research team will review your medical history and current medications to confirm if the trial is right for you.
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.
- You are aged 18 or older.
- You currently have active facial or body acne.
- You can commit to applying a gel once daily for 12 weeks.
- You are able to travel to a trial clinic for regular skin checks.
- You are willing to pause any other medicated acne creams if asked by the study doctor.
What does participation involve?
Taking part in this study lasts about 12 weeks. During this time, you will be asked to apply the assigned gel once each day to your face and affected body areas. You will be given either the active medicine or a matching plain gel, decided at random.
You will need to attend several clinic visits over the 12 weeks, including an initial screening visit and a final check-up at week 12. At these appointments, a study doctor will gently examine your skin, count your spots, and assess any redness or swelling. They will also ask how you are feeling and check for any skin irritation or side effects. Between clinic visits, you may be asked to keep a simple diary of when you apply the gel.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
Will I definitely receive the active acne gel?
No. This is a controlled study, meaning participants are randomly assigned to receive either the active gel or a matching plain gel with no medicine.
How long does the study last?
The treatment period lasts for 12 weeks, during which you will apply the gel once a day and attend regular check-ups.
Can I use my normal skincare products during the study?
The study team will give you clear instructions on which gentle cleansers or moisturisers you can use, and which medicated acne products you must avoid.
Does taking part cost anything?
No. The study gel, clinic visits, and medical check-ups are provided free of charge, and travel expenses may be covered.
What happens if my skin gets worse or irritated?
You can contact the study doctor at any time. If the gel causes uncomfortable irritation, the doctor may pause or stop the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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