What is the mechanism of action of this treatment?

Common treatments for midface volume loss, such as saypha® VOLUME Lidocaine, involve the injection of hyaluronic acid-based dermal fillers. These fillers work by attracting and retaining water, which provides immediate volume and hydration to the treated area. The addition of lidocaine helps to reduce discomfort during the procedure. This approach is significant for patients as it offers a minimally invasive method to restore facial contours, improve aesthetic appearance, and enhance overall facial symmetry.

What side effects are associated with this type of intervention?

Common side effects of dermal fillers with lidocaine, such as hyaluronic acid fillers used for midface volume restoration, include temporary redness, swelling, pain, bruising, and tenderness at the injection site. Less frequently, patients may experience lumps or bumps under the skin, infection, or allergic reactions. Rare but serious complications can include vascular occlusion, which may lead to tissue necrosis or blindness if not promptly treated.

What prior FDA approvals exist?

The FDA has approved several hyaluronic acid-based dermal fillers for the treatment of midface volume loss, including Juvéderm® Voluma™ XC and Restylane Lyft. These products are designed to restore volume and contour to the midface area. Juvéderm® Voluma™ XC, for example, is a non-animal stabilized hyaluronic acid (NASHA) gel with lidocaine, which provides immediate volume restoration and reduces injection discomfort. Similarly, Restylane Lyft is another NASHA filler with lidocaine, approved for midface augmentation and correction of age-related volume loss. These treatments are similar to saypha® VOLUME Lidocaine, which is currently being studied for the same indication.

What other types of research exist?

Promising alternatives to saypha® VOLUME Lidocaine for midface volume restoration include: 1) Juvéderm® Voluma™ XC, which has been shown to be effective in midface augmentation. 2) SardenyaShape® (a new monophasic hyaluronic acid filler), which has demonstrated efficacy in correcting nasolabial folds and could be considered for midface volume restoration. 3) Restylane LYFT®, a biphasic hyaluronic acid filler, which has also been used effectively for facial volume restoration.

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Dermal Filler

Saypha® VOLUME Lidocaine vs. Juvéderm® Voluma™ XC for Midface Volume Loss (VOLIDO Trial)

Phase 3

Waitlist Available

Led By Elyse S Rafal, MD

Research Sponsored by Croma-Pharma GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation

Males 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)

Must not have

Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, 8, 16, 24, 36, and 48

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a facial filler with a numbing agent on people with significant midface volume loss due to aging. The filler is injected to restore facial fullness and reduce discomfort during the procedure.

Who is the study for?

This trial is for adults aged 22-75 with moderate to severe midface volume loss, who are healthy in the treatment area and not planning any facial procedures during the study. Women must test negative for pregnancy and use birth control; men must agree to contraception if their partners can bear children.

What is being tested?

The trial tests saypha® VOLUME Lidocaine against Juvéderm® Voluma™ XC for midface augmentation. It's a randomized, controlled study where neither participants nor evaluators know which treatment is given, aiming to show saypha® is as good as Juvéderm®.

What are the potential side effects?

Potential side effects may include reactions at the injection site like redness or swelling, allergic responses, or more serious complications such as vision changes or skin color alterations around the eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My midface skin is healthy and free from conditions that could affect aging assessments.

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I agree to use contraception or am surgically sterilized.

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I have moderate to severe cheek volume loss on both sides.

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I am between 22 and 75 years old.

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I am capable of becoming pregnant and have a negative pregnancy test.

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I am not pregnant and agree to use effective birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have infections or cancerous growths in the area to be treated.

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I have not had facial surgery or used long-lasting fillers where the device will be applied.

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I have had or plan to have cosmetic treatments in the midface area.

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I will have weight-loss surgery as part of my initial treatment.

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I haven't used any blood thinners or certain anti-inflammatory drugs around my treatment times.

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I have facial volume loss due to injury or HIV-related issues.

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I have had a condition where my lymphocytes grow abnormally.

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I have not had weight loss surgery in the last year.

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I had a side effect from my first treatment that is still affecting me.

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I've had herpes simplex in the treatment area three times in the last year.

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I've had herpes simplex in the treatment area three times in the last year.

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I don't use blood thinners or certain anti-inflammatory drugs around the time of my treatment.

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I have an autoimmune or connective tissue disease, or I am currently on immuno-modulating therapy.

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I am undergoing or have undergone facial fat reduction treatment.

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I experienced serious side effects after my last injection, like vision changes or skin color changes.

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I haven't had any facial fat reduction treatments in the last year.

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I have not developed an autoimmune disease nor am I on immuno-modulating therapy since the study started.

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I have a midface volume deficit due to a birth defect, injury, or condition like HIV-related lipodystrophy.

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I have had facial plastic surgery or used permanent or semi-permanent fillers.

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I have not had any dermal fillers in the treatment area other than those for this study.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have a history of cancer.

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I have experienced serious side effects related to my eyes or skin after an injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, 8, 16, 24, 36, and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4, 8, 16, 24, 36, and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 8, 16, 24, 36, and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of responders on the 5-point MVDSS at Week 24

Secondary study objectives

Change in Nasolabial Folds Measurements

Evaluation of Injection Volume

Global aesthetic improvement based on modified GAIS as rated by Subject

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: saypha® VOLUME LidocaineExperimental Treatment1 Intervention

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.

Group II: Juvéderm® Voluma™ XCActive Control1 Intervention

0 / 29Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for midface volume loss, such as saypha® VOLUME Lidocaine, involve the injection of hyaluronic acid-based dermal fillers. These fillers work by attracting and retaining water, which provides immediate volume and hydration to the treated area. The addition of lidocaine helps to reduce discomfort during the procedure. This approach is significant for patients as it offers a minimally invasive method to restore facial contours, improve aesthetic appearance, and enhance overall facial symmetry.

Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies.