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New filler shows promise for dark Under-Eye hollows

NCT ID NCT04577898

Symptom relief Sponsor: Teoxane SA Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a gel filler called RHA Redensity Eye to improve moderate to severe under-eye hollows (sunken areas). 248 adults were randomly assigned to receive the filler or no treatment. The main goal was to see if the filler reduced hollow severity after 12 weeks, as rated by a blinded evaluator and patient questionnaires.

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

248 people

The number who actually took part.

Started

Dec 2020

Finished

Feb 2025

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

22 years and older

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: * Outpatient, male or female of any race, 22 years of age or older * Infra-orbital Hollows of grade 2 to 3 on the TIOHS (ranging from 0 to 4) who is seeking treatment of moderate to severe tissue volume deficiencies in the infra-orbital region (realistic and achievable as per TI opinion). Bilateral symmetry is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the subject is eligible, the BLE's assessment will be used for the Baseline for the primary endpoint. If the TI and the BLE do not agree on eligibility, or if their assessments differ by 2 points or more on the scale, the subject will not be eligible. * Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations * Able to follow study instructions and complete all required visits. * Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed. Exclusion Criteria: * Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control * Known hypersensitivity/allergy to any component of the study devices * Clinically significant active skin disease within 6 months * Has a history of or currently has an auto-immune disease.

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As listed by the trial registrant

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

Infra-orbital hollows Tear-trough deformity Wrinkle

Contacts and locations

Locations

  • United States, California

    Encino, California, 91436, United States

  • United States, Florida

    Coral Gables, Florida, 33146, United States

  • United States, Illinois

    Chicago, Illinois, 60611, United States

  • United States, Santa Monica

    Santa Monica, California, 90212, United States

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