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saypha® VOLUME Lidocaine for Midface Volume Loss

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cosmetic Laser Dermatology, San Diego, CAMidface Volume Losssaypha® VOLUME Lidocaine - CombinationProduct
Eligibility
22 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares two different treatments for the same medical condition to see which works better.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Lidocaine Cream 5%
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10XB-101 Solution for Injection
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Modified GCN+TTF treatment

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Week 4, 8, 16, 24, 36, and 48

Week 2
Evaluation of Injection Volume
Subject´s pain assessment
Week 4
Change in Nasolabial Folds Measurements
Global aesthetic improvement based on modified GAIS as rated by Subject
Global aesthetic improvement based on modified GAIS as rated by blinded evaluator
Mean change in midface volume deficit
Mean change in midface volume deficit as measured by volumetric change measurement
The percentage of responders on the 5-point MVDSS at Weeks 4, 8, 16, 36, and 48 as rated by the blinded evaluator
The percentage of responders on the 5-point MVDSS at Weeks 4, 8, 16, 36, and 48 as rated by the independent blinded photographic reviewer
Week 24
The percentage of responders on the 5-point MVDSS at Week 24
Week 4
Subject's assessment of satisfaction with appearance based on FACE-Q(TM)
Subject's assessment of satisfaction with outcome appraisal based on FACE-Q(TM)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Lidocaine Cream 5%
2
10XB-101 Solution for Injection
1
Modified GCN+TTF treatment

Side Effects for

Tumescent Solution With Dilute Epinephrine
40%Nausea
10%Vomiting
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01602692) in the Tumescent Solution With Dilute Epinephrine ARM group. Side effects include: Nausea with 40%, Vomiting with 10%.

Trial Design

2 Treatment Groups

Juvéderm® Voluma™ XC
1 of 2
saypha® VOLUME Lidocaine
1 of 2

Active Control

Experimental Treatment

486 Total Participants · 2 Treatment Groups

Primary Treatment: saypha® VOLUME Lidocaine · No Placebo Group · Phase 3

saypha® VOLUME Lidocaine
CombinationProduct
Experimental Group · 1 Intervention: saypha® VOLUME Lidocaine · Intervention Types: CombinationProduct
Juvéderm® Voluma™ XC
CombinationProduct
ActiveComparator Group · 1 Intervention: Juvéderm® Voluma™ XC · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 4, 8, 16, 24, 36, and 48

Who is running the clinical trial?

Croma-Pharma GmbHLead Sponsor
20 Previous Clinical Trials
2,714 Total Patients Enrolled
Elyse S Rafal, MDPrincipal InvestigatorDermResearchCenter of New York
1 Previous Clinical Trials
1,152 Total Patients Enrolled

Eligibility Criteria

Age 22 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The skin on your cheeks must be healthy and without any skin conditions that could affect the evaluation of aging.
You agree not to have any cosmetic or surgical procedures in the treatment area during the study, including Botox injections (except for treatment in the area between the eyebrows or forehead).
You understand what the study is about and have agreed to participate by signing a form. You are able to attend all the scheduled study visits.
To be considered for the study, you must meet certain requirements for your initial treatment.
You are between the ages of 22 and 75 years old.
You have a noticeable loss of volume in both sides of your midface, as assessed by the investigator at the site.
If you are a woman who can become pregnant, you must have a negative pregnancy test and agree to use a very effective form of birth control during the entire study.
If you are a man with a female partner who can have a baby, you must use protection during the whole study.

Who else is applying?

What state do they live in?
Nebraska50.0%
Texas50.0%
What site did they apply to?
Skin Specialists100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "Very interested in your study please contact me"
What questions have other patients asked about this trial?
  • "How long is the study ?"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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