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New filler takes on juvederm for wrinkle reduction

NCT ID NCT06509477

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new dermal filler called Lunaphil Ultra works as well as the established Juvederm Ultra 4 for treating moderate to severe nasolabial folds (smile lines). 104 adults received one filler on one side of the face and the other on the opposite side, with results measured by wrinkle severity and aesthetic improvement. The goal was to see if Lunaphil Ultra is a safe and effective alternative.

What this could mean

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

Active substance
Hyaluronic acid dermal filler (Lunaphil Ultra or Juvederm Ultra 4)
What this could lead to
If successful, this could show that Lunaphil Ultra is a safe and effective alternative to Juvederm for reducing deep smile lines.
What could go wrong
This is a small, completed equivalency study, not a large phase 3 trial. Results may not apply to all skin types or other wrinkles, and individual results vary.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

104 people

The number who actually took part.

Started

Dec 2021

Finished

Nov 2023

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Subjects ≥ 30 years of age * Visible bilateral NLFs that were approximately symmetrical and had an equal severity ranging from moderate to severe (assessed at the deepest part) * Able to follow study instructions and likely to complete all required visits * Signed informed consent Exclusion Criteria: * History of bleeding disorders or participants receiving or recently exposed (≤ 3 weeks) to continuous treatment with thrombolytics, anticoagulants, platelet inhibitors, or NSAIDs * Acute herpetic eruption * Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders * Known sensitivity to local anesthetics of the amide type (such as lidocaine), history of hypersensitivity to gram-positive bacterial proteins, history of multiple severe allergies, history of anaphylactic shock * Known hypersensitivity to any component of the study products or excipients (like hyaluronic acid) * History of receiving immune therapy or a history of autoimmune disease * History of active chronic debilitating systemic disease * History of connective tissue disease, history of malignancy (except for non-melanoma skin cancer) within the last 5 years * Clinically significant active dermatologic disorders within the last 6 months * Use of oral retinoids, over-the-counter (OTC) or prescription antiwrinkle treatments, microdermabrasion, or chemical peels in the NLF area within the last 4 weeks or intention to use them during the study * Any prior cosmetic procedure or tissue augmentation at the NLF injection site within 1 year before study entry (or intent to undergo such a procedure during the study) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Orchid Pharmed, Medical Department

    Tehran, 19947-66411, Iran