Status:
COMPLETED
A Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold
Lead Sponsor:
Jetema Co., Ltd.
Conditions:
Nasolabial Fold
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
Eligibility Criteria
Inclusion
- Subjects who desire temporary improvement of both nasolabial folds and who has rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) (the rating does not have to be the same for both sides)
- Subjects who have agreed to discontinue all dermatological treatments or procedures, including those for facial wrinkles improvement in the facial area, during the clinical trial period
- Subjects capable of understanding and complying with directions and who can participation for the full duration of the clinical trial period
- Subjects who have voluntarily decided to participate in the clinical trial and have given written consent by signing the subject informed consent form
Exclusion
- Subjects who have been administered an antithrombotic agent (with the exception of low dosage aspirin (100mg, maximum 300mg/day)) within 2 weeks of the date of the screening
- Subjects who have had a history of any bleeding disorder, in the past or the present
Key Trial Info
Start Date :
February 23 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT07150273
Start Date
February 23 2016
End Date
July 28 2017
Last Update
September 8 2025
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