Active not recruitingPHASE4INTERVENTIONAL

Post-Menopause Skin Rejuvenation Study

This study is for women aged 40-65 who have gone through menopause and are experiencing skin changes like dryness, thinning, or loss of firmness. It explores how two injectable treatments, Sculptra and Restylane SkinBoosters, can help rejuvenate the skin. Sculptra works by encouraging your skin to make more of its natural collagen, which can improve firmness. Restylane SkinBoosters help hydrate the skin and improve its texture and elasticity. Researchers want to understand if treating dryness first with Restylane, then firmness with Sculptra, is better than the other way around. The goal is to find the most effective way to help post-menopausal skin look and feel healthier.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Erevna Innovations Inc.

Enrolment target

Start

14 Aug 2025

Estimated completion

28 Sep 2026

Aesthetic Menopause Post-menopause Injectables Biostimulator Hyaluronic Acid

What is this study about?

When women go through menopause, their bodies produce less oestrogen. This can lead to noticeable changes in the skin, such as it becoming drier, thinner, less firm, and more prone to wrinkles. We know these changes can affect how you feel about your skin.

This study is looking at two types of injectable treatments that are already used to improve skin. One is called Sculptra Aesthetic, which is a 'biostimulator'. This means it works by gently encouraging your own body to produce more collagen, a natural protein that helps keep skin firm and supple. Over time, this can help improve the skin's structure and make it look smoother and firmer. The other treatment is Restylane SkinBoosters Vital, which uses a substance called hyaluronic acid. This substance is naturally found in the skin and is excellent at holding water, so it helps to deeply hydrate the skin, making it feel softer and look more elastic.

The main idea behind this study is that both hydration (how moist your skin is) and firmness (how much it sags) are key concerns for women after menopause. Researchers want to see if combining these two treatments works well, and crucially, if the order of treatment makes a difference. For example, is it better to improve hydration first then firmness, or the other way around? By understanding this, doctors may be able to offer more tailored and effective treatments in the future to help women feel more confident about their skin.

Key takeaways

This study explores skin treatments for women after menopause.
It uses two injectables: Sculptra for firmness and Restylane for hydration.
Researchers want to find the best order for these treatments.
Participants will be women aged 40-65 with skin ageing signs.
You can participate whether or not you are on HRT.
Involves clinic visits for treatments and skin assessments.

Who may be eligible?

This study is looking for women between 40 and 65 years old who have definitely gone through menopause. To be in the study, you need to have skin changes associated with ageing on your face or chest area, such as wrinkles, dryness, or skin that feels less firm.

You might be able to join if you are currently taking Hormone Replacement Therapy (HRT) or if you haven't been on HRT for at least six months. It's important that you are generally in good health.

However, you won't be able to take part if you've had similar injectable treatments (like other 'biostimulators' or hyaluronic acid fillers) in the last 18 months in the study areas. Also, if you have certain health conditions like uncontrolled long-term illnesses, or specific nerve or skin problems, you wouldn't be suitable. Your doctor will carefully check your medical history to make sure it's safe for you to participate.

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.

Are you a woman between 40 and 65 years old?
Have you gone through menopause (no periods for at least 12 months)?
Do you have signs of skin ageing on your face or chest, like wrinkles, dry skin, or skin that feels less firm?
Have you avoided similar skin injectable treatments in the last 18 months?
Are you generally in good health?
Are you willing and able to attend all study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will primarily revolve around receiving specific skin treatments and having your skin assessed. After agreeing to take part and going through an initial check-up, you'll be placed into one of two groups. One group will receive Restylane SkinBoosters first, followed by Sculptra, while the other group will receive Sculptra first, followed by Restylane. Both treatments involve injections into the skin of your face or chest area.

You will have several appointments at the clinic for your treatments and for follow-up assessments. During these visits, the study team will examine your skin and ask you questions about how it feels and looks. The exact number of visits and the full duration of your participation (including follow-up) will be explained in detail before you decide to join. You won't be given any specific medication to take at home for this study, but it's important to attend all scheduled appointments.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improvements in the hydration, firmness, and overall appearance of your skin. These treatments are already available, but this study helps us understand the best way to combine them for women after menopause. As with any medical procedure involving injections, there are potential risks, such as temporary bruising, swelling, redness, or discomfort at the injection sites. More rarely, there could be other side effects which your doctor will discuss with you. You will be closely monitored by medical professionals throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Erevna Innovations Inc.
Verified postcode
Montreal, Canada

Common questions

What are 'injectable treatments'?

These are treatments given with a small needle, placed just under the skin, to help improve its appearance and health.

What is the difference between Sculptra and Restylane?

Sculptra helps your body make more of its own collagen for firmer skin. Restylane SkinBoosters hydrate your skin deeply for better texture and elasticity.

Will I know which treatment I'm getting first?

Yes, you will be assigned to one of two groups, and the study team will explain which treatment you will receive first.

How long will I be in the study?

The full duration of the study, including all visits and follow-ups, will be clearly explained to you before you agree to take part.

Is HRT (Hormone Replacement Therapy) allowed in this study?

Yes, women who are either taking HRT or not taking HRT can be part of this study, as long as other conditions are met.