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| Name | Class |
|---|---|
| Health Policy Associates | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumina | Experimental | Lumina Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. |
|
| Restylane Defyne | Active Comparator | Restylane Defyne Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Product | Device | up to 2cc per injection of filler placed into nasolabial fold. |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary effectiveness Wrinkle Severity Rating Scale (WSRS) | The mean change from baseline of NLFs in the Lumina™ treatment arm will be compared to that of NLFs in the Restylane® Defyne control arm. (5 point scale with 1 being no visible NLF and 5 being extreme, deep and long NLFs) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS other timepoint | Individual endpoints at each timepoint of other than 6 month for mean change from baseline on the WSRS scale, as determined by the live, masked evaluator | 6 weeks, 3, 9, and 12 months |
| WSRS proportions |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | to assess the rate and severity of adverse events from initial treatment through last study visit. | 13 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sashank Reddy, M.D. | LifeSprout, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussels - Brussels University Hosptal | Brussels | Belgium | ||||
| FACCIA |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2025 | Jun 24, 2025 | 3 | ||
| Jul 30, 2025 |
Parallel assignment to product to different sides of face, per randomization code. At 12 months subjects may be retreated only with study product (partial cross over potential)
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A blinded evaluator at each site who does not know what patient was treated with what product (per side) scores the patient. Photographic reviewers are also blinded to treatment.
| Active Control | Device | up to 2cc per injection of filler placed into nasolabial fold. |
|
|
proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS
| 6 weeks, 3, 6, 9, and 12 months |
| Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator | Individual endpoints for each rater type, as rated by the live, masked evaluator (5 point scale with 1 being most improvement and 5 being worsened) | 6 weeks, 3, 6, 9, and 12 months |
| GAIS Subject | Individual endpoints for each rater type, as rated by the study subject. | 6 weeks, 3, 6, 9, and 12 months |
| GAIS Investigator | Individual endpoints for each rater type, as rated by treating investigator | 6 weeks, 3, 6, 9, and 12 months |
| FACE-Q (standardized questionnaire developed by Memorial Sloan Kettering) Appraisal of Nasolabial Folds Questionnaire | change from baseline for Lumina™ and Restylane® Defyne on the Subject FACE-Q Appraisal of Nasolabial Folds Questionnaire | 6 weeks, 3, 6, 9, and 12 months |
| Visual Analog Scale (VAS) Pain | pain assessment in NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne at initial injection | injection |
| WSRS Photographics | Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for mean change from baseline on the WSRS scale for NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne, as rated by a photographic reviewer. | 6 weeks, 3, 6, 9, and 12 months |
| Proportion WSRS photographic | proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS, as determined by a photographic reviewer | 6 weeks, 3, 6, 9, and 12 months |
| Lisbon |
| Portugal |
| British Aesthetics | London | United Kingdom |
| PHP Aesthetic-PHP Wellness | London | United Kingdom |
| Aug 14, 2025 |
| 4 |