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

NCT07162610 | Active Not Recruiting

• 1 other identifier: PR-Rejuviel-P3-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mid-face volume deficit; Mid face volume

Outcome Measures

Primary Outcomes (1)

• Percentage improvement in mid-face volume

  Percentage improvement in mid-face volume at Weeks 24 after the final administration of the investigational medical device, as assessed by independent photo evaluators compared with baseline

  at Weeks 24 after the final administration

Study Arms (2)

Rejuviel V with lidocaine

EXPERIMENTAL

Single injection and optional touch up injection in Midface

Device: Rejuviel V® with lidocaine

JUVEDERM® VOLUMA® with lidocaine

ACTIVE COMPARATOR

Single injection and optional touch up injection in Midface

Device: JUVEDERM® VOLUMA® with lidocaine

Interventions

Rejuviel V® with lidocaine DEVICE

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

Also known as: Cleviel volume plus with lidocaine

Rejuviel V with lidocaine

JUVEDERM® VOLUMA® with lidocaine DEVICE

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

JUVEDERM® VOLUMA® with lidocaine

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Korean men and women aged ≥30 years and ≤65 years at the time of informed consent.
• At screening, subjects with a score of 3 (moderate) or higher on the Mid Face Volume Deficit Scale (MFVDS), as assessed by independent on-site evaluators, with symmetrical deficits in both mid-face regions including the zygomatic area, anterior medial cheek, and subzygomatic area.
• Subjects who agree not to undergo any other procedures (e.g., filler injections other than the investigational medical device, laser treatment, chemical peeling, botulinum toxin, or facial plastic surgery) during the course of the clinical trial.
• Subjects who are able to understand and follow instructions and participate throughout the entire duration of the clinical trial.
• Subjects who voluntarily provide written informed consent to participate in the clinical trial.

You may not qualify if:

• History of anaphylaxis or severe allergic reactions requiring treatment.
• History of hypertrophic scars, keloids, or post-inflammatory hyperpigmentation.
• Use of anticoagulants (e.g., warfarin), antiplatelets, thrombolytics, immunosuppressants, or NSAIDs within 2 weeks prior to screening, or intake of other agents that may prolong coagulation time (e.g., vitamin E, garlic, ginkgo); Low-dose aspirin ≤300 mg/day permitted; participation allowed after ≥5 half-lives washout of the active compound.
• Use of topical facial medications (steroids, retinoids; excluding cosmetics) within 4 weeks prior to screening or planned during the study.
• Known hypersensitivity to investigational device components (sodium hyaluronate, lidocaine, lidocaine hydrochloride hydrate) or to amide-type local anesthetics (lidocaine, prilocaine, etc.).
• History of autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, autoimmune hemolytic disease).
• History of sarcoidosis, granulomatous disease, or Osler's endocarditis.
• Active skin disease, inflammation, infection, scar, or wound at the treatment area.
• History or presence of herpetic eruption.
• Bleeding disorders.
• Severe hepatic dysfunction (ALT or AST \>3 × ULN).
• Coagulation abnormalities (INR \>1.5 × ULN).
• Prior or planned facial procedures/surgeries that may affect outcomes; permanent implants (e.g., PMMA, silicone, Gore-Tex) in treatment area.
• History of malignancy within the past 5 years.
• Drug or alcohol abuse.

Sponsors & Collaborators

• PharmaResearch Co.,Ltd: lead

Study Sites (1)

Chung-Ang University Hospital

Soeul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Subject \& Evaluator-blinded, Matched Pairs, Non-inferiority

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: April 7, 2024
• Primary Completion: March 8, 2026
• Study Completion: March 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)