Saypha® VOLUME Lidocaine for Midface Augmentation

Conditions

• Moderate to Severe Midface Volume Deficit

Eligibility Criteria

Sex

ALL

Age

22 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• saypha® VOLUME Lidocaine — COMBINATION_PRODUCT
  Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride.
• Juvéderm® Voluma™ XC — COMBINATION_PRODUCT
  Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride

Study Details

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).

Key Dates

First listed

May 23, 2022

Start date

Aug 16, 2022

Status verified

Aug 2024

Primary completion

Oct 4, 2023

Completion

Dec 11, 2024

Study Design

Enrollment

562 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: saypha® VOLUME Lidocaine
  For injection, either a needle (27G ½'') or cannula (25G 1½") may be used. Randomization will be stratified by injection equipment in a 1:1 ratio. The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year.
• Active Comparator: Juvéderm® Voluma™ XC
  For injection, either a needle (27G ½'') or cannula (25G 1½") may be used. Randomization will be stratified by injection equipment in a 1:1 ratio. The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year.
• Experimental: saypha® VOLUME Lidocaine - Open Label Extension
  All participants who complete Arms 1 and 2 may optionally enroll and receive the experimental treatment.

Primary Outcome Measure

The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset [ Time Frame: Week 24 ]

Locations (16)

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