Can a new filler smooth smile lines as well as the gold standard?

NCT ID NCT07770789

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether a new hyaluronic acid filler called Rejeunesse Shape with lidocaine works as well as an existing filler, Restylane Perlane, for improving nasolabial folds (the lines from nose to mouth). Healthy adults aged 30 to 60 with moderate to severe folds will receive one of the two fillers. Researchers will compare wrinkle improvement and pain levels to see if the new filler is a viable alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rejeunesse Shape with lidocaine, a hyaluronic acid (HA) dermal filler injected into the skin to temporarily smooth wrinkles
What this could lead to
If successful, this could offer a new, safe option for temporarily reducing the appearance of nasolabial folds, with comparable results to an existing filler.
What could go wrong
This is a single-center trial with a modest number of participants, and results may not apply broadly. As with any injectable filler, there are risks like swelling, bruising, or uneven results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

71 people

The number who actually took part.

Started

Feb 2016

Finished

Nov 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women aged more than 30 but less than 60; 2. Those with score 3 or 4 in the wrinkle severity rating scale (WSRS) among those who want the improvement of nasolabial folds; 3. Those with visually symmetrical with nasolabial folds; 4. Those who agree with the suspension of all the dermatological treatment including the improvement of wrinkle on the face during the clinical study; 5. Those who are able to read and follow instructions and participate during the entire period of clinical study; 6. Those who decide to participate in the clinical study on their wills and agree with the subject-agreement written form. Exclusion Criteria: 1. Those with skin sensitiveness on the clinical medical devices according to the result of intradermal test in the screening period; 2. Those who were administered with the antithrombotic (I00mg, up to 300mg/day) or anti-steroid anti-inflammatory within 2 days from the screening; 3. Those taking the antithrombotic (low-capacity aspirin (100mg, up to 300mg/day) excluded) during the clinical study or abnormal blood coagulation or liver function; 4. Those who have used or are scheduled to use the part ointment on the facial surface within 4 weeks from the screening date (steroid, retinoid: only for the medicines and not the cosmetics); 5. Those treated for the improvement of wrinkle or pimp within 6 months from the screening date; 6. Those treated for improvement of wrinkle by using collagen or hyaluronic acid filler within 6 months from the screening date or decortication, skin regeneration treatment, or plastic surgery on the facial surface (including botox wrinkle treatment); 7. Those treated with application of clinical medical devices for CaHA (Calcium Hydroxy Apatite) within a year from the screening date; 8. Those inserted with permanent skin extending implant such as soft form or silicon on the facial surface 9. Those in need of treatment on facial surface but with scar not treated for more than a year or with scar on the areas applied with clinical medical devices; 10. Those with the history of anaphylaxis or sever complex allergy symptoms; 11. Those with history of hypertropic scar or keloid medical history; 12. Those with side effect on the EMLA cream in the past (NIA for the criteria of exclusion for subjects who are not to use the EMLA cream); 13. Those with skin problem or infection from cut influencing on this clinical study; 14. Those with degraded immune function; 15. Those with clinically serious problem on cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system or mental disease that significantly influences on this clinical study; 16. Those participating in other clinical studies within 30 days from the screening date; 17. Those who did not agree to participate in the contraception in the medically allowed methods among female subjects who are able to be pregnant during the clinical study; \* Medically allowed contraception method: Condom, oral contraception for more than 6 months, cases of using shot or inserting anti-conceptive or installing conceptive device in the womb; 18. Pregnant women or lactating women; 19. Other than aforementioned subjects, those with clinical opinion regarding them as inappropriate subjects in this study from the medical judgment from charging person or manager of this study.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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