RecruitingNAINTERVENTIONAL

Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers

This research study is looking at the safety of a new skin product called Mitopure Topical Formula. We need healthy adult volunteers to apply this product to their skin so we can check for any unwanted reactions. The main goal is to find out if the product is safe for general use. If you're generally healthy, aged 18 or over, and don't have any current skin conditions or allergies to face products, you might be able to take part. Volunteers will need to avoid using other facial products during the study and attend regular check-ups. This is an important step to ensure new skin care items are well-tolerated before they become widely available.

At a glance

Status

Recruiting

Phase

Sponsor

Amazentis SA

Enrolment target

Start

20 Apr 2026

Estimated completion

15 Sep 2026

Healthy Adult

What is this study about?

This study, called "Human Skin Safety Testing of 1 Mitopure Topical Product," is all about checking how safe a new skin product, Mitopure Topical Formula, is when healthy people use it. Think of it like a thorough check-up for the product itself to make sure it's gentle and doesn't cause any irritation or bad reactions when applied to the skin.

We need healthy adult volunteers to help us with this. By applying the product as instructed, you'll allow researchers to carefully watch for any signs of skin redness, dryness, itching, or other changes. This is a really important step before any new product can be considered for wider use, as it helps companies make sure their products are safe and well-tolerated.

The information gathered from this study will help ensure that future skin products using Mitopure are safe for everyone. Your participation would be a valuable contribution to understanding how this product interacts with human skin.

Key takeaways

This study tests the safety of a new skin product called Mitopure Topical Formula.
Healthy adults (18+) are needed as volunteers.
You'll apply the product and attend regular skin check-ups.
You must avoid other facial products during the study.
It helps ensure new products are safe for future use.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you need to be a healthy adult, aged 18 or older. You'll also need to agree to carefully follow all instructions and attend all appointments. It's important that you're willing to only use the study product on your face and avoid other facial creams, washes, or even new laundry detergents or perfumes throughout the study.

There are certain reasons why you might not be able to participate. For example, if you are pregnant, breastfeeding, or planning to become pregnant, or if you have any current skin conditions like eczema, psoriasis, or rosacea. We also can't include anyone who has severe allergies to face products or a history of serious illnesses affecting major organs like your heart, liver, or kidneys. If you have any cuts, scratches, or significant marks on your face that might make it hard for doctors to check your skin, you might not be eligible.

Quick self-check

Are you a healthy adult aged 18 or over?
Do you have clear skin, free from conditions like eczema or severe acne?
Are you willing to only use the study product on your face and avoid others?
Can you attend all scheduled appointments?
Are you not pregnant, breastfeeding, or planning to become pregnant?

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 first have a meeting where the study will be fully explained, and you'll be asked to sign a consent form. You'll be given the Mitopure Topical Formula to use on your skin at home. During the study, it's very important that you only use this specific product on your face and avoid all other facial serums, cleansers, and even new laundry detergents or fragrances.

You'll need to attend all scheduled study visits at the clinic. At these visits, doctors or nurses will carefully examine your skin to check for any changes or reactions to the product. They will assess things like redness, dryness, or irritation. The study involves several appointments spread out over a period that will be explained to you. You'll need to commit to attending these regularly and following all instructions carefully. The total duration of your involvement will be made clear before you agree to participate.

Potential risks and benefits

Taking part in any study has potential aspects to consider. A potential benefit of this study is contributing to the research and understanding of new topical products, helping to ensure they are safe for others in the future. As this is a safety study, the primary goal is to look for any unwanted effects. While every effort is made to ensure safety, potential risks could include mild skin irritation, redness, or itching from the product, though these would be closely monitored. 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 is Mitopure Topical Formula?

It's a new skin product being tested to see how safe it is when applied to human skin.

Do I need to be ill to join this study?

No, this study is specifically looking for healthy adult volunteers to test the product's safety.

Will I have to put anything else on my face during the study?

No, you must only use the study product on your face and avoid other facial serums or cleansers.

How long will I be involved in the study?

The total duration of your participation, including visits and product use, will be explained to you before you start.

What happens if I change my mind?

You can withdraw from the study at any time, for any reason, without it affecting your medical care.

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.