Clinical trial NCT02721368: Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume
Official title: Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2016-03-29
Enrollment: 88
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
3. Those who has thin skin in the mid-facial area
4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics

\<Extension Study\>

Inclusion Criteria:

1. Participated in the pivotal study and completed the end of study visit
2. 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

Exclusion Criteria

1. Those who have following procedual history between completion of the pivotal study and entry of extension study

   - facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting
2. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment

Primary outcomes:
measure: Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
timeFrame: 24 weeks
measure: Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
timeFrame: 104 weeks
Secondary outcomes:
measure: The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit
timeFrame: 104 weeks
measure: Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Medical Center
state: Dongjak-gu
Study officials:
affiliation: Chung-Ang Univ. Medical Center
name: BeomJoon Kim
role: PRINCIPAL_INVESTIGATOR
References: