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
NCT07150273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2025-09-08
Summary
A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
Conditions
- Nasolabial Fold
Interventions
- DEVICE
-
UNIVELO Sub-Q 2mL
Test device
- DEVICE
-
Restylane Sub-Q 2mL
Comparator Device
Sponsors & Collaborators
-
Jetema Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-23
- Primary Completion
- 2017-03-23
- Completion
- 2017-07-28
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