RecruitingNAINTERVENTIONAL

Human Skin Safety Testing of 1 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

This study is looking at a new skin product called Mitopure Topical Formula 11. The main goal is to find out if it causes any irritation or allergic reactions on people's skin. Healthy adult volunteers will take part, including some with sensitive skin. They will have small patches containing the product put on their skin, usually on their back or arm, and these patches will be kept covered. These patches will be applied repeatedly over a period of time to see how the skin reacts. This is a common way to test skin products to make sure they are safe for people to use. It helps ensure that when the product is eventually sold, it's unlikely to cause problems like rashes or itching for most users. The study isn't testing how well the product works, only its safety on the skin.

At a glance

Status

Recruiting

Phase

Sponsor

Amazentis SA

Enrolment target

100

Start

20 Apr 2026

Estimated completion

15 Sep 2026

Irritation/Irritant Sensitisation

What is this study about?

Imagine you're trying a new cream or lotion. Wouldn't you want to know it's safe and won't make your skin red or itchy? This study is doing just that for a product called Mitopure Topical Formula 11. Scientists want to see if this new skin product causes any problems like a rash, redness, or an allergic reaction when it's put on the skin. They are especially interested in making sure it won't irritate even sensitive skin. This kind of testing is really important because it helps make sure that new products are gentle and safe for everyone to use.

To do this, healthy volunteers will take part in something called a 'patch test'. This means small patches containing the Mitopure product will be placed on their skin, usually on their back or arm. These patches will stay on for a while and then be removed. This process will be repeated several times over a few weeks. The researchers will carefully check the skin where the patches were placed to see if there are any signs of irritation or a reaction.

This study isn't about whether the product makes your skin look better or helps with a specific skin problem. It's purely about physical safety — checking if the ingredients in the Mitopure product are kind to the skin and don't cause unwanted reactions. Knowing this helps companies create products that are safe and comfortable for people to use every day.

Key takeaways

The study tests a new skin product for irritation and allergic reactions.
It uses skin patches on healthy adult volunteers.
Some people with sensitive skin are specifically included.
The goal is purely to check the product's safety on skin.
This is NOT a study about how well the product works.

Who may be eligible?

To join this study, you need to be a healthy man or woman who is at least 18 years old. Importantly, about half of the participants will be people who know they have sensitive skin, as this helps researchers see how the product performs on different skin types. If you're a woman of childbearing age, you'll need to agree to use a reliable method of birth control during the study, or confirm that you are past menopause or have had certain surgeries like a hysterectomy.

However, there are some reasons why you wouldn't be able to join. If you are pregnant or breastfeeding, this study is not for you. Also, if you've been part of a similar skin patch test in the last month, you won't be able to participate just yet. Finally, if you're currently being treated by a doctor for allergies, the study doctors would need to talk to your own physician to make sure it's safe for you to take part.

Quick self-check

Are you 18 years old or older?
Are you generally healthy?
If you're a woman, are you using birth control or past menopause?
Are you NOT pregnant or breastfeeding?
Have you NOT been in a similar skin patch test in the last month?
Do you NOT have a serious allergy that your doctor hasn't approved for study participation?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll have several visits to the study clinic over a few weeks. During these visits, small patches containing the Mitopure product will be carefully placed on your skin, typically on your back or arm. These patches will usually stay on for a day or two and then be removed by the study staff. You won't be given any medication to take, as this study is only about how the product reacts on your skin. The total time you'll be involved in the study will be a specific number of weeks, which the study team will explain in detail. You'll need to make sure you can attend all scheduled visits to have the patches applied and assessed.

Potential risks and benefits

A potential benefit of joining this study is helping to ensure that new skin products are safe for everyone to use. You won't directly benefit from the product itself, as this study is not testing its effectiveness for any skin condition. The main potential risk is that you might experience some skin irritation, redness, itching, or a mild allergic reaction where the patches are applied – this is exactly what the study is looking for to ensure safety. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

PCR Corp
Manchester, United Kingdom· Recruiting

Common questions

What will I put on my skin?

You will have small patches with a new product called Mitopure Topical Formula 11 placed on your skin. These patches will be similar to sticking plasters.

Will this product treat a skin condition?

No, this study is not about treating any skin problems. It's only to check if the product is safe and doesn't cause irritation or allergies.

How long will the study take?

The study involves several visits over a few weeks. The research team will tell you the exact timeline at your first visit.

Do I need to take any medicine?

No, you will not need to take any medication as part of this study. It only involves product being placed on your skin.

Can I leave the study at any time?

Yes, you can decide to stop participating in the study at any point, and you don't need a reason.

How to find out more

Brad Currier, PhD

bcurrier@timeline.com +41215521272 Official trial record

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