Saypha® VOLUME Lidocaine for Midface Augmentation
Public ClinicalTrials.gov record NCT05386030. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Subject- and Evaluator-blinded, Controlled, Non-inferiority Multicenter, Parallel Group Comparison Study to Evaluate Effectiveness and Safety of Saypha® VOLUME Lidocaine for Midface Augmentation to Correct Volume Deficit
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
Study identification
- NCT ID
- NCT05386030
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 562 participants
Conditions and interventions
Conditions
Interventions
- saypha® VOLUME Lidocaine Combination Product
- Juvéderm® Voluma™ XC Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 22 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2022 (Actual)
- Primary completion
- Oct 4, 2023 (Actual)
- Completion
- Dec 11, 2024 (Actual)
- Last update posted
- Apr 9, 2026
2022 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clear Dermatology & Aesthetics Center | Scottsdale | Arizona | 85255 | — |
| Clinical Testing of Beverly Hills | Encino | California | 91436 | — |
| Center for Dermatology Cosmetic & Laser Surgery | Fremont | California | 94538 | — |
| Cosmetic Laser Dermatology | San Diego | California | 92121 | — |
| About Skin | Greenwood Village | Colorado | 80111 | — |
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | — |
| Skin Associates of South Florida | Coral Gables | Florida | 33146 | — |
| Meridian Clinical Research, Georgia Plastic Surgery | Savannah | Georgia | 31406 | — |
| Chicago Cosmetic | Chicago | Illinois | 60654 | — |
| Skin Specialists | Omaha | Nebraska | 68144 | — |
| Imagedermatology PC | Montclair | New Jersey | 07042 | — |
| Luxurgery | New York | New York | 10021 | — |
| DermResearchCenter of NY | Stony Brook | New York | 11790 | — |
| Aesthetic Solutions | Chapel Hill | North Carolina | 27517 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| DermResearch Inc. Austin | Austin | Texas | 78759 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05386030, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 9, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05386030 live on ClinicalTrials.gov.