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Efficacy and Safety of Rejuviel V in the Correction of Midface Volume Deficit

NCT07162610 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-09-09

No results posted yet for this study

Summary

The purpose is to evaluate the efficacy and confirm the safety of Rejeunesse Contour® with Lidocaine compared to Juvederm® Voluma® with Lidocaine for the temporary improvement of mid-face volume (including the cheekbone area, the anterior-medial cheek, and the area below the cheekbone).

The investigational medical device will be administered a total of once during the entire clinical trial period (or up to twice if additional treatment is required). After the administration, photographs of the application site and evaluations using the Mid-Face Volume Deficit Scale (MFVDS) will be conducted at 4 weeks, 12 weeks, 24 weeks, and 48 weeks. Satisfaction with mid-face volume improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Additionally, changes in concomitant medications/treatments and adverse events will be reviewed in comparison to the previous visit.

Conditions

  • Mid-face Volume Deficit

Interventions

DEVICE

Rejuviel V® with lidocaine

Crosslinked hyaluronic acid (HA) 22 mg/mL + 0.3% lidocaine hydrochloride.

DEVICE

JUVEDERM® VOLUMA® with lidocaine

Crosslinked hyaluronic acid (HA) 20 mg/mL + 0.3% lidocaine hydrochloride.

Sponsors & Collaborators

  • PharmaResearch Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-07
Primary Completion
2026-03-08
Completion
2026-03-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162610 on ClinicalTrials.gov