Trials / Active Not Recruiting
Active Not RecruitingNCT04839484
LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds
A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Lumina™ in the Treatment of Nasolabial Folds
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- Sponsor
- LifeSprout, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina™ for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina™) in one NLF and control (Restylane® Defyne) in the contra-lateral NLF. 118 subjects will be treated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Study Product | up to 2cc per injection of filler placed into nasolabial fold. |
| DEVICE | Active Control | up to 2cc per injection of filler placed into nasolabial fold. |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2022-09-04
- Completion
- 2023-03-01
- First posted
- 2021-04-09
- Last updated
- 2022-09-10
Locations
4 sites across 3 countries: Belgium, Portugal, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04839484. Inclusion in this directory is not an endorsement.