CompletedNot Applicable

Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume

South Korea88 participantsStarted 2016-11-03

Plain-language summary

The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject aged between 35 and 65.
✓. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level

Exclusion criteria

✕. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
✕. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
✕. Those who has thin skin in the mid-facial area
✕. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
✕. Participated in the pivotal study and completed the end of study visit
✕. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
✕. Those who have following procedual history between completion of the pivotal study and entry of extension study
✕. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment

What they're measuring

Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

Timeframe: 24 weeks

Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

Timeframe: 104 weeks

Trial details

NCT IDNCT02721368

SponsorMedy-Tox

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-31

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject aged between 35 and 65.
✓. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level

Exclusion criteria

✕. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
✕. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
✕. Those who has thin skin in the mid-facial area
✕. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
✕. Participated in the pivotal study and completed the end of study visit
✕. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
✕. Those who have following procedual history between completion of the pivotal study and entry of extension study
✕. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment

What they're measuring

Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

Timeframe: 24 weeks

Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

Timeframe: 104 weeks