Using TEOSYAL RHA® 1 to treat volume loss under the eyes in Chinese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation evaluates the effectiveness of TEOSYAL RHA® 1, a hyaluronic acid dermal filler, in correcting moderate to severe tissue volume deficiencies in the infraorbital region among Chinese adults. Participants will be randomly assigned to receive either the treatment or no treatment in a 3:1 ratio. The study will assess the safety and effectiveness of the treatment over a period of 52 weeks with multiple follow-up visits. The primary goal is to determine if TEOSYAL RHA® 1 is superior to no treatment for this specific condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Chinese male and female, 18 years of age or older.
2. Subject seeking treatment of moderate to severe tissue volume deficiencies in the infraorbital region.
3. Subjects with a grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes, as determined on assessments by the Treating Investigator (TI) and BLE.
4. Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, Intense Pulsed Light \[IPL\], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
5. Woman of childbearing potential agree to use contraception during the investigation.
6. Subject understands and is able to follow instructions and complete all scheduled visits.
7. Subjects who voluntarily decided to participate in the investigation and signed the informed consent.

Exclusion Criteria:

1. Known hypersensitivity or previous allergic reaction to any component of the study device.
2. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
3. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
4. History of connective tissue disease.
5. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
6. Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.

Where it's running

• Guangdong Second Provincial General Hospital
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Elise Gondard
• Email: e.gondard@teoxane.com
• Phone: +41223449636

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hyaluronic acid fillers for lips, cheeks, nasolabial folds, perioral lines, and under-eye hollows in everyday practice

  This trial will try hyaluronic acid dermal fillers in adults who want cosmetic treatment of the lips, cheeks, nasolabial folds, perioral lines, or infraorbital hollows to see how long the effects last and to record safety.

  Recruiting at 8 sites Symatese · Arras and 7 other locations · NCT07255261

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.