Evaluation of the Safety and Efficacy of Profhilo® Structura
This study is investigating a new treatment called Profhilo® Structura, designed to help with skin ageing. It’s an injectable gel made from hyaluronic acid, a substance naturally found in our skin. The aim is to restore lost fat tissue in the face and neck, reduce skin wrinkles and sagging, and improve skin elasticity and hydration. Researchers want to see how safe and effective Profhilo® Structura is compared to not having treatment. It’s intended for adults aged 35 to 55 who have mild to moderate facial volume loss or acne scars. The study will help us understand if this treatment can genuinely improve the appearance of ageing skin.
At a glance
What is this study about?
This study is about a new treatment called Profhilo® Structura, which is an injectable gel. Our skin naturally contains something called hyaluronic acid, which helps keep it hydrated, elastic, and firm. As we get older, or sometimes due to weight loss, we lose some of this natural hyaluronic acid, which can lead to wrinkles, sagging skin, and a loss of fullness in our face.
Profhilo® Structura is made from a special blend of different types of hyaluronic acid. It's designed to be injected into the skin to help replace what's been lost. The idea is that it will hydrate the skin deeply, improve its elasticity and firmness, and help to gently lift and restore lost volume, especially in the face. It could also help with repairing skin in people with acne scars.
Scientists want to carefully check if this new treatment is safe and if it actually works to improve these ageing signs. They are comparing it to a 'sham' treatment, which means some people will receive the actual treatment and some won't, to see the real effects of Profhilo® Structura. This helps them understand truly how well it works and for whom.
Key takeaways
- Tests a new skin treatment (Profhilo® Structura) for ageing and volume loss.
- Uses hyaluronic acid, a natural skin component.
- Aimed at people aged 35-55 with mild to moderate facial ageing or acne scars.
- Compares the treatment to no treatment (sham group).
- Focuses on safety and how well it works.
Who may be eligible?
To join this study, you need to be a healthy man or woman between 35 and 55 years old. You should be looking for a treatment to improve wrinkles, sagging skin, or lost volume in your face or neck. If you’re a woman who could become pregnant, you'll need to have a negative pregnancy test and use reliable birth control throughout the study.
There are some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or planning to become pregnant during the study, you cannot take part. If you have any serious or long-lasting health conditions that might affect the study results or your safety, you also wouldn't be able to participate. You also shouldn't have had too many aesthetic treatments before that might interfere with the study's findings.
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.
- Am I aged between 35 and 55 years old?
- Am I generally healthy?
- Am I looking to improve wrinkles, sagging, or lost facial volume?
- If I am a woman who could get pregnant, am I willing to use reliable birth control?
- Do I agree to keep my weight stable during the study?
- Do I agree to use SPF50 sun cream daily?
What does participation involve?
The study involves a specific number of visits over a certain period. At your first visit, you'll learn all about the study and decide if you want to take part. If you do, you'll sign a consent form. You might receive the Profhilo® Structura treatment, or you might be in the group that doesn't receive treatment (the 'sham' group). During your visits, qualified staff will administer the treatment if you're in that group. They will also gently check your skin's condition and take measurements to see how the treatment is working. You'll be asked to keep using your usual skincare and apply a strong sun cream (SPF50) throughout the study. We don’t have details on the exact number or timing of these visits, or the total duration, but this will be fully explained to you if you decide to inquire about participation.
Potential risks and benefits
Locations (3)
- Eurofins Dermscan PharmascanVerified postcodeVilleurbanne, France· Recruiting
- Eurofins Dermscan PolandVerified postcodeGdansk, Poland· Not yet recruiting
- Aesthetic clinicalVerified postcodePoznan, Poland· Not yet recruiting
Common questions
What is Profhilo® Structura?
It's an injectable gel containing hyaluronic acid, a natural substance in our skin, designed to improve signs of skin ageing like wrinkles and volume loss.
Who can take part in this study?
Healthy men and women aged 35 to 55 who want to improve the appearance of facial ageing or acne scars.
Will I definitely get the treatment?
You might get the Profhilo® Structura treatment, or you might be in a group that doesn't receive treatment to help compare the effects.
What do I need to do during the study?
You'll have study visits, possibly receive injections, and be asked to continue your regular skincare and use SPF50 sun cream.
Are there any side effects?
Like any injection, there could be temporary side effects like bruising or swelling. The study team will explain all known risks.
How to find out more
Gilberto Bellia
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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