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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, 8, 16, 24, 36, and 48
Awards & highlights
VOLIDO Trial Summary
This trial compares two different treatments for the same medical condition to see which works better.
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.Check my eligibility
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®.See study design
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.
VOLIDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My midface skin is healthy and free from conditions that could affect aging assessments.
Select...
I agree to use contraception or am surgically sterilized.
Select...
I have moderate to severe cheek volume loss on both sides.
Select...
I am between 22 and 75 years old.
Select...
I am capable of becoming pregnant and have a negative pregnancy test.
Select...
I am not pregnant and agree to use effective birth control during the study.
VOLIDO Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of responders on the 5-point MVDSS at Week 24
Secondary outcome measures
Change in Nasolabial Folds Measurements
Evaluation of Injection Volume
Global aesthetic improvement based on modified GAIS as rated by Subject
+8 moreSide effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
VOLIDO 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
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.
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Who is running the clinical trial?
Croma-Pharma GmbHLead Sponsor
23 Previous Clinical Trials
3,033 Total Patients Enrolled
Elyse S Rafal, MDPrincipal InvestigatorDermResearchCenter of New York
1 Previous Clinical Trials
1,152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to have cosmetic or surgical procedures in the treatment area during the study.I have infections or cancerous growths in the area to be treated.I have not had facial surgery or used long-lasting fillers where the device will be applied.I am able to become pregnant and agree to use effective birth control during the study.I am not planning any dental work around the time of my injection treatments.My midface skin is healthy and free from conditions that could affect aging assessments.I have had or plan to have cosmetic treatments in the midface area.I will have weight-loss surgery as part of my initial treatment.I haven't used any blood thinners or certain anti-inflammatory drugs around my treatment times.To be considered for the study, you must meet certain requirements for your initial treatment.I am between 22 and 75 years old.I have moderate to severe cheek volume loss that is about the same on both sides.I have facial volume loss due to injury or HIV-related issues.I have had a condition where my lymphocytes grow abnormally.I agree not to have cosmetic or surgical procedures in the treatment area during the study.I understand the study's purpose, have given consent, and can attend all visits.I have not had weight loss surgery in the last year.I had a side effect from my first treatment that is still affecting me.I've had herpes simplex in the treatment area three times in the last year.I tend to develop thick or keloid scars and/or have skin color disorders.I haven't had dermal fillers in the treatment area for the last 2 years.I've had herpes simplex in the treatment area three times in the last year.I don't use blood thinners or certain anti-inflammatory drugs around the time of my treatment.I have an autoimmune or connective tissue disease, or I am currently on immuno-modulating therapy.I haven't had cancer in the last 5 years, except for skin cancer.I do not have an active COVID-19 infection or symptoms, nor have I had any respiratory symptoms in the last 14 days.I have had significant vision changes or serious health issues after injections.I am undergoing or have undergone facial fat reduction treatment.I experienced serious side effects after my last injection, like vision changes or skin color changes.I haven't had any facial fat reduction treatments in the last year.I have not developed an autoimmune disease nor am I on immuno-modulating therapy since the study started.I agree to use contraception or am surgically sterilized.I do not have an active COVID-19 infection or symptoms, or I tested negative if I had symptoms in the last 14 days.I've had serious vision changes or health issues after previous injections.I have a midface volume deficit due to a birth defect, injury, or condition like HIV-related lipodystrophy.My diabetes or other systemic diseases have not worsened since the study began.I have moderate to severe cheek volume loss on both sides.I have had facial plastic surgery or used permanent or semi-permanent fillers.I have not had any dermal fillers in the treatment area other than those for this study.I am between 22 and 75 years old.I understand the study's purpose, have given my consent in writing, and can attend all required visits.I have moderate to severe cheek volume loss that is fairly even on both sides.I am capable of becoming pregnant and have a negative pregnancy test.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I am not currently in another clinical trial or have taken any experimental drugs/devices within the last 30 days or five half-lives of the drug.I have a history of cancer.I have no dental surgeries planned from 4 weeks before to 4 weeks after the injection.I have not had any cosmetic treatments in the midface area in the past year.I am not pregnant and agree to use effective birth control during the study.I have experienced serious side effects related to my eyes or skin after an injection.My midface skin is healthy and free from conditions that could affect aging assessments.I am a male and will use contraception during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Juvéderm® Voluma™ XC
- Group 2: saypha® VOLUME Lidocaine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Midface Volume Loss Patient Testimony for trial: Trial Name: NCT05386030 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial accept volunteers over the age of twenty?
"This trial seeks adult participants younger than 75 and older than 22 years of age."
Answered by AI
Are there still opportunities for volunteers to participate in the trial?
"As noted on clinicaltrials.gov, this investigation is actively in need of participants. It was initially posted online on August 16th 2022 and underwent its most recent update during February 21st 2023."
Answered by AI
How risky is the utilization of saypha® VOLUME Lidocaine for patients?
"Testing and evaluation of saypha® VOLUME Lidocaine has yielded a safety rating 3, due to the multiple rounds of data that support its efficacy and corroborate its safety."
Answered by AI
How extensive is the geographic reach of this clinical investigation?
"This trial is currently operating out of 16 medical sites, some examples being Savannah, Scottsdale and Encino. In order to save time and effort, it would be wise for potential participants to select the clinic closest them when enrolling."
Answered by AI
What is the current participant count for this research endeavor?
"For this research to be conducted, the sponsor Croma-Pharma GmbH needs 486 patients who meet their specified criteria. The trial will run out of multiple sites including Meridian Clinical Research, Georgia Plastic Surgery in Savannah and Clear Dermatology & Aesthetics Center in Scottsdale, Arizona."
Answered by AI
Who would be a feasible candidate for this clinical experiment?
"This clinical trial is enrolling 486 participants aged between 22 and 75 who have moderate to severe midface volume loss. In order for individuals to be included in this study, they must meet the following requirements: Baseline treatment; inhabiting a certain age range (from 22 -75 years); having bilateral symmetric midface volume deficit (scored 2 or 3 on the 5-point Midface Volume Deficit Severity Scale); women of childbearing potential with negative urine pregnancy test results AND agreement to use highly effective birth control methods; males with female partners of childbearing potential agreeing to contraception throughout the research period; healthy skin not affected"
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
Texas
North Carolina
What site did they apply to?
Chicago Cosmetic
Skin Specialists
Aesthetic Solutions
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
i would like to to test the new fillers. Very interested in your study please contact me.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the study ?
PatientReceived no prior treatments
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