Actively Recruiting
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
Led by Teoxane SA · Updated on 2025-01-28
260
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 safety assessments. Each treated subjects will receive a safety phone call 3 days after the initial treatment at baseline, and after the touch-up treatment, if any. Their participation in the trial ends after the completion of the follow up period. All non treated subjects (control group) will return to the site at 2, 4, and 12 weeks after randomization for effectiveness and safety assessments. Their participation in the investigation ends after the effectiveness and safety assessments at 12 weeks after randomization.
CONDITIONS
Official Title
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese male and female, 18 years of age or older
- Seeking treatment for moderate to severe tissue volume deficiencies in the infraorbital region
- Infraorbital hollow grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes as assessed by the investigator and blinded evaluator
- Willing to avoid other facial aesthetic procedures that might affect study evaluations during participation
- Women of childbearing potential agree to use contraception during the study
- Able to understand instructions and complete all scheduled visits
- Voluntarily signed informed consent to participate in the study
You will not qualify if you...
- Known allergy or sensitivity to any component of the study device
- Sensitivity to amide-type local anesthetics, history of severe allergies, or anaphylactic shock
- History of active chronic debilitating systemic disease that makes participation unsafe
- History of connective tissue disease
- Significant alcohol or drug abuse, or history of poor cooperation or unreliability
- Participation in another clinical trial within 30 days or within an exclusion period from a previous study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Second Provincial General Hospital
Guangzhou, China
Actively Recruiting
Research Team
E
Elise Gondard
CONTACT
S
Sophie Delhomme
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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