Active not recruitingNAINTERVENTIONAL

LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds

This research study, called the LifeSprout Lumina™ Study, is looking into a new treatment called Lumina™ for common facial lines known as nasolabial folds, or 'smile lines'. These are the lines that run from the sides of your nose down to the corners of your mouth. The main aim is to check if Lumina™ is both safe and effective at reducing these wrinkles. For this study, some participants will receive Lumina™ on one side of their face and a widely used, approved treatment called Restylane® Defyne on the other side, so the effects can be directly compared. About 118 people will take part in this trial to help doctors understand if Lumina™ could be a good new option for treating these lines.

At a glance

Status

Active not recruiting

Phase

Sponsor

LifeSprout, Inc.

Enrolment target

118

Start

02 Mar 2021

Estimated completion

01 Mar 2023

Nasolabial Fold

What is this study about?

This study is exploring a new cosmetic treatment called Lumina™ designed to help reduce the appearance of nasolabial folds. These are the lines that stretch from the sides of your nose down to the corners of your mouth, often becoming more noticeable with age. Many people seek treatments to soften these lines, and this study aims to see if Lumina™ could be a safe and effective new option.

To ensure we get the most accurate results, the study is designed very carefully. It's 'randomised,' which means participants are chosen by chance to receive a specific treatment. It's also 'split-face,' meaning each participant will have Lumina™ applied to one of their nasolabial folds and a comparison treatment (Restylane® Defyne, which is already a known treatment) to the other. This allows doctors to directly compare the two treatments on the same person.

The study is 'double blind,' which means neither you nor your doctor will know which treatment is on which side of your face. This helps prevent anyone's expectations from affecting the results. Around 118 people will be involved in this trial. By doing this research, we hope to learn if Lumina™ can become a valuable and safe option for people looking to reduce their nasolabial folds.

Key takeaways

This study tests a new treatment, Lumina™, for smile lines.
It compares Lumina™ to an existing treatment (Restylane® Defyne) on the same person.
Neither you nor your doctor will know which side gets which treatment.
You must be at least 22 years old and have specific types of smile lines.
Participation involves several follow-up visits over about a year.
You cannot have other facial treatments that might interfere with the results.

Who may be eligible?

To join this study, you need to be at least 22 years old and have moderate to severe nasolabial folds on both sides of your face that a doctor has checked. You must also be prepared not to have other cosmetic procedures on your face, especially around the nasolabial folds, for at least 12 to 13 months, as these could affect the study's results. It's also important that you can attend all scheduled follow-up visits.

There are several reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, planning to get pregnant, or are a woman of childbearing age not using effective birth control, you cannot participate. You also can't join if you've had surgery on your nasolabial folds or have certain serious health conditions like uncontrolled diabetes or autoimmune diseases that an investigator feels might put you at risk.

Also, if you've recently taken part in another medical study involving a new treatment or device in the last 30 days, or if you work directly for the study site or sponsor, you wouldn't be able to join. Your doctor during the study would be able to give you a full overview of all the criteria to ensure the study is right and safe for you.

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 at least 22 years old?
Do you have noticeable 'smile lines' on both sides of your face (as assessed by a doctor)?
Are you able to attend all study appointments for about a year?
Are you willing to avoid other facial cosmetic treatments for the study's duration?
Are you not pregnant, breastfeeding, or planning a pregnancy during the study (if applicable)?
Have you not had surgery on your smile lines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a screening visit to check if you meet all the requirements. If you're eligible, you'll be enrolled in the study. During the treatment visit, Lumina™ will be applied to one of your nasolabial folds, and a standard treatment (Restylane® Defyne) will be applied to the other. Neither you nor your study doctor will know which treatment is on which side.

After your treatment, you will need to attend several follow-up visits over a period of 12 to 13 months. These visits are to check how well the treatments are working and to monitor your health. You must be able to attend all these appointments. During this time, you will need to avoid other cosmetic treatments on your face that could interfere with the study's results.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment (Lumina™) that could improve the appearance of your nasolabial folds. You will also receive careful medical attention and monitoring throughout the study. However, there are potential risks, including side effects from the treatments, which your study doctor will discuss in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UZ Brussels - Brussels University Hosptal
Verified postcode
Brussels, Belgium
FACCIA
Verified postcode
Lisbon, Portugal
British Aesthetics
Verified postcode
London, United Kingdom
PHP Aesthetic-PHP Wellness
Verified postcode
London, United Kingdom

Common questions

What are nasolabial folds?

Nasolabial folds are the lines that run from the sides of your nose down to the corners of your mouth, often called 'smile lines' or 'laugh lines'.

What is Lumina™?

Lumina™ is a new gel treatment being tested in this study to see if it can safely and effectively reduce the appearance of nasolabial folds.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment (Lumina™ or the standard treatment) is applied to which side of your face.

How long will the study last if I join?

The study involves follow-up visits for about 12 to 13 months after your treatment.

Can I have other facial treatments during the study?

No, you must avoid other cosmetic treatments on your face, especially around the nasolabial folds, as these could affect the study results.