Nasolabial Folds Clinical Trial
Official title:
A Prospective, Multi-Center, Randomized, Controlled, Subject- and Evaluator-Blinded, Non-Inferior Clinical Investigation of the Safety and Effectiveness of TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults
This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults. Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine. The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0. All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06018987 -
A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds
|
Phase 2/Phase 3 | |
| Completed |
NCT01115634 -
Autologous Fibroblast Transplantation in Facial Deformities
|
Phase 2 | |
| Completed |
NCT01012661 -
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
|
Phase 4 | |
| Completed |
NCT00778531 -
Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds
|
Phase 4 | |
| Completed |
NCT03932045 -
A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds
|
N/A | |
| Completed |
NCT02647853 -
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01069354 -
Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds
|
N/A | |
| Completed |
NCT00797459 -
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
|
N/A | |
| Completed |
NCT00850889 -
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
|
Phase 4 | |
| Recruiting |
NCT06093321 -
A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement
|
N/A | |
| Not yet recruiting |
NCT06295172 -
A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement
|
N/A | |
| Completed |
NCT01060943 -
An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds
|
Phase 3 | |
| Completed |
NCT05612958 -
Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds
|
N/A | |
| Completed |
NCT02672644 -
Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep
|
Phase 4 | |
| Completed |
NCT01012388 -
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
|
Phase 4 | |
| Completed |
NCT01635855 -
Belotero Post Approval Study
|
Phase 4 | |
| Completed |
NCT02179736 -
A Post Market Evaluation After Treatment of Nasolabial Folds
|
N/A | |
| Terminated |
NCT00716443 -
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
|
Phase 4 | |
| Recruiting |
NCT02607670 -
Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds
|
Phase 2 | |
| Completed |
NCT00823069 -
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
|
N/A |