Trials / Completed
CompletedNCT01940575
Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold
Clinical Trial to Evaluate the Safety and Efficacy of SkinPlus-Hyal® as Tissue Restorative Biomaterials in the Improvement of Bilateral Nasolabial Fold Wrinkles
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 123 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Accepted
Summary
\- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial
Detailed description
* Subjects:Adults with nasolabial fold * Investigational Devices: Study Device: SkinPlus-Hyal® Comparator Device: Restylane® \- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SkinPlus-Hyal® | The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner. |
| DEVICE | Restylane® | The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-01-01
- Completion
- 2014-03-01
- First posted
- 2013-09-12
- Last updated
- 2014-04-08
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01940575. Inclusion in this directory is not an endorsement.