Saypha® VOLUME Lidocaine for Midface Augmentation

NCT05386030 | Completed Phase 3 Results FDA Device

• 1 other identifier: CPH-301-201417
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 16

Brief Summary

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).

Conditions

Moderate to Severe Midface Volume Deficit

Outcome Measures

Primary Outcomes (2)

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

  The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline.

  Week 24

• The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset

  The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. Subjects with missing baseline MVDSS score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were imputed as non-responders.

  Week 24

Secondary Outcomes (11)

• The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator

  Weeks 4, 8, 16, 36, and 48

• The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer

  Weeks 4, 8, 16, 24, 36, and 48

• Mean Change in Midface Volume Deficit

  Weeks 4, 8, 16, 24, 36, and 48

• Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement

  Weeks 4, 8, 16, 24, 36, and 48

• Change in Nasolabial Folds Measurements

  Weeks 4, 8, 16, 24, 36, and 48

Study Arms (3)

saypha® VOLUME Lidocaine

EXPERIMENTAL

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.

Combination Product: saypha® VOLUME Lidocaine

Juvéderm® Voluma™ XC

ACTIVE COMPARATOR

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.

Combination Product: Juvéderm® Voluma™ XC

saypha® VOLUME Lidocaine - Open Label Extension

EXPERIMENTAL

All participants who complete Arms 1 and 2 may optionally enroll and receive the experimental treatment.

Combination Product: saypha® VOLUME Lidocaine

Interventions

saypha® VOLUME Lidocaine COMBINATION_PRODUCT

Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride.

saypha® VOLUME Lidocaine; saypha® VOLUME Lidocaine - Open Label Extension

Juvéderm® Voluma™ XC COMBINATION_PRODUCT

Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride

Juvéderm® Voluma™ XC

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 22 - 75 years (inclusive) of age at Screening.
• Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), as assessed by the blinded investigator at the site.
• Females of childbearing potential must have a negative urine pregnancy test and must agree to use an effective method of birth control throughout the entire study. Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
• Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
• Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of entire investigation, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
• Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the investigator.

You may not qualify if:

• Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation
• History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
• History of hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic
• Tendency to keloid formation and/or hypertrophic scars and/ or have pigment disorders
• Known human immune deficiency virus-positive individuals
• Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area
• Re-current (three times a year over the last year) herpes simplex in the treatment area
• History or presence of any autoimmune or connective tissue disease, or current treatment with immuno-modulating therapy
• Uncontrolled (or unstable) Diabetes mellitus or systemic diseases as per investigator discretion
• Previous facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers (e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of device application and during the entire investigation
• Implantation of dermal fillers in the treatment area within the preceding 24 months prior to Visit 1 (Screening) and during the entire investigation
• Subject has received any of the following aesthetic treatments in the midface area: e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet in the outer eye region) within the last 12 months prior to Visit 1, chemical peeling within the last three months prior to Visit 1 or is planning to undergo such procedures during entire investigation.
• Facial lipolysis, including submental fat treatments, within the previous 12 months prior to Visit 1 (Screening) and during the entire investigation
• Bariatric surgery within 12 months prior to Visit 1 (Screening) and during the entire investigation
• History of bleeding disorder and/or use of anticoagulant, antiplatelet, thrombolytic medication, or anti-inflammatory drugs (oral/injectable corticosteroids or non steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., St. John's Wort, high doses of vitamin E supplements) from ten days pre- to seven days post injection (baseline treatment and touch-up treatment)

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (16)

Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, 85255, United States

Location

Clinical Testing of Beverly Hills

Encino, California, 91436, United States

Location

Center for Dermatology Cosmetic & Laser Surgery

Fremont, California, 94538, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

About Skin

Greenwood Village, Colorado, 80111, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Skin Associates of South Florida

Coral Gables, Florida, 33146, United States

Location

Meridian Clinical Research, Georgia Plastic Surgery

Savannah, Georgia, 31406, United States

Location

Chicago Cosmetic

Chicago, Illinois, 60654, United States

Location

Skin Specialists

Omaha, Nebraska, 68144, United States

Location

Imagedermatology PC

Montclair, New Jersey, 07042, United States

Location

Luxurgery

New York, New York, 10021, United States

Location

DermResearchCenter of NY

Stony Brook, New York, 11790, United States

Location

Aesthetic Solutions

Chapel Hill, North Carolina, 27517, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch Inc. Austin

Austin, Texas, 78759, United States

Location

Results Point of Contact

• Title: Clinical Development - Head of Clinical Operations
• Organization: Croma Pharma

clinical.studies@croma.at

+432262684680

Study Officials

• Elyse S Rafal, MD

  DermResearchCenter of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 23, 2022
• Study Start: August 16, 2022
• Primary Completion: October 4, 2023
• Study Completion: December 11, 2024
• Last Updated: April 9, 2026
• Results First Posted: January 16, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)