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

A Prospective, Multi-center, Randomized, No-Treatment Controlled, Evaluator-Blinded, Superiority Clinical Investigation of the Safety and Effectiveness of TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults

This study is testing if a new eye filler can help Chinese adults with volume loss under their eyes feel better about their appearance compared to not getting any treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Teoxane SA (Industry-sponsored)
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06749587 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 and older with moderate to severe infraorbital hollows.

Not a fit: Patients with mild tissue volume deficiencies or those undergoing other facial aesthetic procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of under-eye hollows, enhancing the quality of life for affected patients.

How similar studies have performed: Previous studies on hyaluronic acid fillers have shown positive outcomes for similar aesthetic treatments, suggesting a potential for success in this investigation.

Eligibility criteria

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 this trial is running

Guangzhou

• Guangdong Second Provincial General Hospital — Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Elise Gondard

Conditions Infraorbital Hollows; Dermal Filler; Hyaluronic Acid