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TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults

RecruitingNAAges 18 Years - anyAllTeoxane SA
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In plain words

What the trial is, and whether it could suit you

This is a prospective, multi-center, randomized, no-treatment controlled, evaluator-blinded clinical investigation to identify whether TEOSYAL RHA® 1 is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in Chinese adults. Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 3:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL RHA® 1 in both Infraorbital Hollows (IOH), whereas subjects assigned to the control group will not receive any treatment. The subjects in the treatment group will be treated with RHA1 for the treatment of moderate to severe tissue volume deficiencies in the infraorbital region on Day 0. All treated subjects will return to the site at 2, 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and saf

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • TEOSYAL RHA® 1
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Where

1 site
Guangdong Second Provincial General Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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