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A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Algeness DF 3.5% | Experimental | This arm is with the Sponsor's product. The product is already CE Marked and sold for this indication for the majority of participating countries. |
|
| Juvéderm Voluma | Active Comparator | This arm is with a Control product that is already CE Marked and sold for this indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algeness® DF 3.5% | Device | dermal filler CE Mark approved for treatment of cheek and midface volume loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator | Statistical non inferiority of Study Product to Control by live Masked Evaluator of Subjects showing atleast a 1 point improvement. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 1+ grade Improvement on Midface Scale Live Masked Evaluator All timepoints | 1+ grade improvement from baseline in midface scale by masked evaluator. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme) | 1, 3, 9, 12, 18, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Midface Scale Live Masked Evaluator All timepoints | Individual endpoints for change from baseline on the Midface Scale as rated by a live, masked evaluator. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme) | 1, 3, 9, 12, 18, 24 months |
| GAIS Live Masked Evaluator |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HEATHER ASTLEY | Contact | 7813292993 | hastley@healthpolicyassociates.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| J. Vandeputte, Plastische Chirurgie | Recruiting | Oudenaarde | Belgium |
All summary results will be posted to this website. Safety results will be shared with medical monitor and study physicians.
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3:1 randomization to either study product or comparator. If subject loses volume in cheek and/or returns to baseline score at or after 12month visit, he/she may be treated with study product.
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The evaluator is blinded as to patient treatment. Patients are also not told what treatment they receive.
| Juvéderm Voluma | Device | dermal filler CE Mark approved for treatment of cheek and midface volume loss |
|
GAIS Scores of Study Product and Comparator on Global Aesthetics Improvement Scale (GAIS) by live Masked Evaluator |
| 1, 3, 9, 12, 18, 24 months |
| GAIS Investigator | GAIS Scores of Study Product and Comparator on Global Aesthetic Improvement Scale (GAIS) by Treating Investigator | 1, 3, 9, 12, 18, 24 months |
| GAIS Patient | GAIS Scores of Study Product and Comparator on Global Aesthetic Improvement Scale (GAIS) by Patient | 1, 3, 9, 12, 18, 24 months |
| Patient Reported FACE-Q | FACE-Q Satisfaction with Cheeks and Age Appraisal scales | 1, 3, 9, 12, 18, 24 months |
| Treatment Duration | Duration of treatment effect as measured on the Midface Scale by ≥1 point improvement, for those subjects who did not receive retreatment prior to the assessment timepoint at months 18 and 24. | 1, 3, 6, 9, 12, 18, 24 months |
| Midface Photo | treatment effect as measured on the Midface Scale by ≥1 point improvement as graded by a blinded photographic reviewer | 1, 3, 6, 9, 12, 18, 24 months |
| Midface Photo Change from Baseline | Individual endpoint of change from baseline score on the Midface Scale as rated by blinded photographic reviewer | 1, 3, 6, 9, 12, 18, 24 months |
| MEDITI | Recruiting | Antibes | France |
| THINKIN | Recruiting | Paris | 75016 | France |
| Rosenpark Research GmbH | Recruiting | Darmstadt | Germany |
| Private Practice for Dermatology and Aesthetics | Recruiting | Munich | Germany |
| Shamir Medical Center | Recruiting | Ẕerifin | Israel |
| Clique Clinic | Not yet recruiting | Petaling Jaya | Malaysia |
|
| Beauty Beyond Skin (Ocean Clinic Marbella) | Recruiting | Marbella | Spain |
| Galadari Derma Clinic | Recruiting | Dubai | United Arab Emirates |