Mid-face Volume DeficitNCT07162610
Efficacy and Safety of Rejuviel V in the Correction of Midface Volume Deficit
A study testing Rejuviel V® with lidocaine and JUVEDERM® VOLUMA® with lidocaine in people with Mid-face Volume Deficit, run by PharmaResearch Co.,Ltd at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mid-face Volume Deficit
- What is being tested?
- Rejuviel V® with lidocaine and JUVEDERM® VOLUMA® with lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Heavy smoking (>20 cigarettes/day).
- Requirement for continuous immunosuppressive therapy during the study.
- Active inflammatory conditions requiring systemic anti-inflammatory treatment (including streptococcal diseases).
- Thin skin in the mid-face or fluid retention tendency in lower eyelids/infraorbital fat pads.
- Use of wrinkle-preventive medical devices or drugs in the mid-face within 3 months prior to screening, or planned during the study.
- Untreated epilepsy.
- Porphyria.
- Use of another investigational medical device or drug within 3 months prior to screening.
- Female subjects of childbearing potential who are unwilling to use medically acceptable contraception during the study, or who are pregnant, breastfeeding, or planning pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Subject & Evaluator-blinded, Matched Pairs, Non-inferiority, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With Rejuviel V® With Lidocaine as Compared to JUVEDERM® VOLUMA® With Lidocaine for Temporary Restoration of Mid-face Volume
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
- Being tested
- Rejuviel V® with lidocaine, JUVEDERM® VOLUMA® with lidocaine
- Keywords
- Mid-face volume deficit, Mid face volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rejuviel V® with lidocaineDevice
Also called Cleviel volume plus with lidocaine
Crosslinked hyaluronic acid (HA) 22 mg/mL + 0.3% lidocaine hydrochloride.
JUVEDERM® VOLUMA® with lidocaineDevice
Crosslinked hyaluronic acid (HA) 20 mg/mL + 0.3% lidocaine hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| Rejuviel V with lidocaine | Experimental | Single injection and optional touch up injection in Midface Receives: Device: Rejuviel V® with lidocaine |
| JUVEDERM® VOLUMA® with lidocaine | Active comparator | Single injection and optional touch up injection in Midface Receives: Device: JUVEDERM® VOLUMA® with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at Weeks 24 after the final administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start7 Apr 2024
- Primary completion8 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-face Volume DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Subject \& Evaluator-blinded, Matched Pairs, Non-inferiority
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaResearch Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162610
- Sponsor's protocol ID
- PR-Rejuviel-P3-01
- Status last verified
- May 2026
- First submitted
- 31 Aug 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Subject & Evaluator-blinded, Matched Pairs, Non-inferiority, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With Rejuviel V® With Lidocaine as Compared to JUVEDERM® VOLUMA® With Lidocaine for Temporary Restoration of Mid-face Volume
- ClinicalTrials.gov ID
- NCT07162610
- Acronym / sponsor ID
- PR-Rejuviel-P3-01
- Conditions
- Mid-face Volume Deficit
- Keywords
- Mid-face volume deficit, Mid face volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- PharmaResearch Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Subject \& Evaluator-blinded, Matched Pairs, Non-inferiority
| Arm | Type | Receives |
|---|---|---|
| Rejuviel V with lidocaine | Experimental | Device: Rejuviel V® with lidocaineSingle injection and optional touch up injection in Midface |
| JUVEDERM® VOLUMA® with lidocaine | Active comparator | Device: JUVEDERM® VOLUMA® with lidocaineSingle injection and optional touch up injection in Midface |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rejuviel V® with lidocaineAlso: Cleviel volume plus with lidocaineCrosslinked hyaluronic acid (HA) 22 mg/mL + 0.3% lidocaine hydrochloride. | Device | Rejuviel V with lidocaine |
| JUVEDERM® VOLUMA® with lidocaineCrosslinked hyaluronic acid (HA) 20 mg/mL + 0.3% lidocaine hydrochloride. | Device | JUVEDERM® VOLUMA® with lidocaine |
Primary outcome
Percentage improvement in mid-face volume
Time frame: at Weeks 24 after the final administration
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rejuviel V® with lidocaine and JUVEDERM® VOLUMA® with lidocaine in people with Mid-face Volume Deficit, run by PharmaResearch Co.,Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage improvement in mid-face volume (time frame: at Weeks 24 after the final administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.