A double-blind, prospective, randomised, placebo-controlled, single-centre, proof-of-principle trial in healthy volunteers to investigate safety, local tolerability, pharmacokinetics, and pharmacodynamics of Asacaine after topical administration on skin exposed to ultraviolet B radiation
This Phase I clinical trial is looking at a new skin treatment called Asacaine. It is designed to relieve local skin pain. Because this is one of the first times Asacaine is being tested in humans, the main goal is to check its safety and see how the body absorbs it. Healthy adult volunteers will take part. Researchers will use a small, controlled amount of ultraviolet B (UVB) light on a tiny patch of skin to create mild, temporary tenderness, similar to a light sunburn. They will then apply either Asacaine cream or a dummy cream (placebo) with no active medicine. Doctors will carefully monitor how the skin reacts, check for side effects, and measure whether the cream reduces skin sensitivity. Taking part helps scientists learn whether Asacaine could become a helpful pain treatment in the future.
At a glance
What is this study about?
Pain that affects the skin and outer tissues can be uncomfortable and hard to treat without causing body-wide side effects from pills. Scientists are developing a new topical medicine—a cream or gel applied directly to the skin—called Asacaine. The hope is that by treating the skin directly, it can soothe pain right where it hurts without affecting the rest of the body.
This trial is an early-stage study, known as Phase I or 'proof-of-principle'. It involves healthy volunteers rather than people with long-term medical conditions. To see if the treatment works on sensitive skin, doctors use a safe, very controlled amount of ultraviolet B (UVB) light on a small patch of skin. This creates a mild, temporary redness and tenderness, much like a mild sunburn, allowing researchers to measure pain relief in a standardised way.
The study is 'double-blind' and 'placebo-controlled'. This means some participants will receive Asacaine, while others will receive a dummy cream that looks identical but contains no active medicine. Neither the volunteers nor the study doctors will know who gets which cream until the end. Comparing the two helps scientists clearly see if any benefits or side effects are truly caused by Asacaine.
Key takeaways
- Tests a new pain-relief cream called Asacaine in healthy volunteers.
- Uses a small, controlled amount of UVB light to test how well the cream eases skin tenderness.
- Mainly focuses on safety, how the skin reacts, and how the body handles the medicine.
- Participants may receive either the real medicine or an inactive dummy cream.
- Participation is entirely voluntary and carefully monitored by doctors.
Who may be eligible?
This study is open to healthy adult volunteers aged 18 and over, including both men and women. Because this is an early safety trial, researchers need people who are generally in good health so that the results are clear and easy to understand.
People with active skin conditions, such as eczema, psoriasis, or very sensitive skin in the test area, are unlikely to be able to take part. This is to make sure the skin reaction from the light test is safe and predictable.
Pregnant or breastfeeding women, and anyone taking medicines that make their skin unusually sensitive to sunlight, will also be excluded for their own safety. The study team will review each volunteer's medical history to confirm they can safely join.
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 consider myself to be in good general health.
- I do not have active skin problems like eczema or psoriasis.
- My skin is not unusually sensitive to sunlight.
- I am not pregnant or breastfeeding.
What does participation involve?
If you take part, you will first attend a screening visit at a single specialist clinic. The study team will explain the trial, answer your questions, and carry out routine health checks, such as checking your blood pressure and examining your skin.
During the trial, a small patch of your skin will be exposed to a precise, mild dose of UVB light to create mild tenderness. The study team will then apply either Asacaine or the dummy cream to the area. You will stay at the clinic for monitoring while doctors check your skin, ask about any sensations or discomfort, and possibly take small blood samples to see how much medicine enters your bloodstream.
After the treatment visits, you will have a follow-up check to make sure your skin has healed normally and that you feel well. The entire study typically involves a few visits over several days to weeks.
Potential risks and benefits
Locations (1)
- —UnverifiedSweden
Common questions
What is Asacaine?
Asacaine is an experimental pain-relief medicine designed to be applied directly to the skin to soothe local pain.
Will the UVB light harm my skin?
The light is carefully measured and applied only to a tiny patch of skin to cause mild, temporary redness like a light sunburn. It heals naturally.
Will I definitely receive the active medicine?
No. This is a randomised trial, so you have an equal chance of receiving Asacaine or an inactive dummy cream (placebo).
Will I be paid for taking part?
Phase I trials with healthy volunteers usually provide reasonable payment or expenses to compensate you for your time and travel.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any point, and you do not need to give a reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.