A phase 2 randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of topical AT-004 1% in the participants with acne vulgaris.
Acne is a common skin condition that causes spots, redness, and inflammation. This phase 2 clinical trial is looking at a new experimental skin treatment called AT-004 1% cream to find out if it is safe and effective for adults with acne vulgaris. Participants will apply either the AT-004 cream or a matching dummy cream (placebo) to their skin. A computer will randomly decide who receives which treatment, and neither you nor your study doctor will know which one you are using. Over about 12 weeks, doctors will monitor your skin to count spots, check for any irritation, and see if the treatment improves your day-to-day wellbeing. Taking part also includes standard health checks, such as blood tests and blood pressure checks, to make sure you stay safe throughout the study.
At a glance
What is this study about?
Acne vulgaris is a very common skin condition that causes blackheads, whiteheads, and painful red spots. While there are many acne products available, they do not work well for everyone and can sometimes cause dry, peeling, or stinging skin. Because of this, doctors are always looking for new treatments that can clear spots while remaining gentle on the skin.
This study is testing a new experimental medicine called AT-004, used as a 1% cream applied directly to the skin. The main goal is to find out if AT-004 can reduce both inflamed, swollen spots and non-inflamed blemishes like blackheads. Researchers will also carefully monitor whether the cream causes any skin reactions, such as redness, itching, or burning.
To ensure the results are trustworthy, the trial compares AT-004 to a placebo, which is an identical cream containing no active medicine. This is a 'double-blind' trial, meaning neither the participants nor the research doctors will know who is using the real medicine and who is using the placebo. This helps prevent bias and ensures any improvements seen are genuine.
Key takeaways
- Tests a new 1% skin cream (AT-004) designed to treat acne.
- Open to adults aged 18 and older with active acne vulgaris.
- Involves a dummy cream (placebo) to fairly test if the medicine works.
- Lasts around 12 weeks with regular clinic visits to monitor your skin.
- Taking part is voluntary and you can leave at any time.
Who may be eligible?
This study is open to men and women aged 18 and older who have active acne vulgaris. You must have a noticeable number of acne spots to help researchers measure whether the treatment makes a difference.
You might not be able to join if you are currently using certain other acne treatments, such as strong prescription gels, antibiotics, or oral acne tablets, as these could interfere with the study results. Having other skin conditions on your face, such as eczema or rosacea, might also mean this trial is not suitable for you.
The study team will review your health, examine your skin, and discuss any medicines you take to help decide if joining the study is safe and 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.
- I am aged 18 or older.
- I have active acne vulgaris on my skin.
- I am willing to attend regular clinic check-ups over 12 weeks.
- I am happy to apply the study cream as directed by the doctors.
- I am willing to pause other medicated acne treatments if advised.
What does participation involve?
If you join the trial, you will take part for around 12 weeks. During this time, you will apply the provided cream (either AT-004 or the placebo) to your affected skin as instructed by the medical team. You will need to visit the study clinic regularly, typically at the start of the study and then at weeks 4, 8, and 12. At these visits, doctors will examine your skin, count your spots, check your vital signs (such as blood pressure and pulse), and ask about any side effects. You will also complete short questionnaires about how your acne affects your daily life and mood. A small group of participants may have extra blood tests to see how much of the medicine gets absorbed into the bloodstream.
Potential risks and benefits
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Common questions
What is a placebo?
A placebo is a dummy treatment that looks, smells, and feels identical to the real study medicine, but contains no active ingredients. It helps researchers prove whether the new medicine actually works.
Will I know if I am getting the real medicine?
No. Neither you nor your study doctor will know whether you are using the real AT-004 cream or the placebo cream. This keeps the study fair and unbiased.
How long will the study take?
The study lasts for about 12 weeks, with key clinic check-ups planned at week 4, week 8, and week 12.
Can I continue using my normal skincare routine?
You may need to pause certain medicated face washes or spot treatments during the study. The study team will give you clear instructions on which gentle cleansers and moisturisers you can safely use.
What happens if I want to stop taking part?
Joining the trial is completely voluntary. You can choose to stop taking part at any time, and your normal medical care will continue as usual.
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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