Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasol… (NCT04569045) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds
China130 participantsStarted 2020-08-20
Plain-language summary
The aim of this study is to evaluate the safety and effectiveness of pain relief of modified sodium hyaluronate gel for injection when used for the correction of moderate or severe nasolabial folds.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 65 years of male or female
* Wrinkle Severity Rating Scale (WSRS) of bilateral nasolabial folds graded 3 or 4 by blinded evaluator (moderate to severe bilateral nasolabial fold), consistent grade of bilateral nasolabial folds, and the grades approved by the physician who perform the treatment
* Agree not to undergo any other under-eye facial surgery (including nose) during the study period
Exclusion Criteria:
* Injection site with infection or other skin diseases present which may affect the evaluation
* With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at nasolabial folds
* With permanent implants or planning to receive permanent implants during the study period at the injection sites
* Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 12 months
* With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
* With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period
* With prescription medication for nasolabial fold treatment, topical corticosteroid, skinirritating topical products or pigmentation products within the past 2 weeks or planning to take these medication or products during the study period
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What they're measuring
1
Immediate VAS pain evaluated after injection for both NLF sides