Nasolabial Fold CorrectionPhase 3NCT07770789
Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects
A Phase 3 study testing Rejeunesse and Restylane Perlane in people with Nasolabial Fold Correction, run by Forest Hills Lab.
Trial summary
Intend to prove the non-inferiority of Rejeunesse against the comparing medical device of Restylane Perlane in terms of improvement, efficacy, and safety of nasolabial fold on the face Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold Correction
- What is being tested?
- Rejeunesse and Restylane Perlane
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2016to 29 Nov 2016
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged more than 30 but less than 60;
- Those with score 3 or 4 in the wrinkle severity rating scale (WSRS) among those who want the improvement of nasolabial folds;
- Those with visually symmetrical with nasolabial folds;
- Those who agree with the suspension of all the dermatological treatment including the improvement of wrinkle on the face during the clinical study;
- Those who are able to read and follow instructions and participate during the entire period of clinical study;
- Those who decide to participate in the clinical study on their wills and agree with the subject-agreement written form.
Who cannot join
- Those with skin sensitiveness on the clinical medical devices according to the result of intradermal test in the screening period;
- Those who were administered with the antithrombotic (I00mg, up to 300mg/day) or anti-steroid anti-inflammatory within 2 days from the screening;
- Those taking the antithrombotic (low-capacity aspirin (100mg, up to 300mg/day) excluded) during the clinical study or abnormal blood coagulation or liver function;
- Those who have used or are scheduled to use the part ointment on the facial surface within 4 weeks from the screening date (steroid, retinoid: only for the medicines and not the cosmetics);
- Those treated for the improvement of wrinkle or pimp within 6 months from the screening date;
- Those treated for improvement of wrinkle by using collagen or hyaluronic acid filler within 6 months from the screening date or decortication, skin regeneration treatment, or plastic surgery on the facial surface (including botox wrinkle treatment);
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- Those treated with application of clinical medical devices for CaHA (Calcium Hydroxy Apatite) within a year from the screening date;
- Those inserted with permanent skin extending implant such as soft form or silicon on the facial surface
- Those in need of treatment on facial surface but with scar not treated for more than a year or with scar on the areas applied with clinical medical devices;
- Those with the history of anaphylaxis or sever complex allergy symptoms;
- Those with history of hypertropic scar or keloid medical history;
- Those with side effect on the EMLA cream in the past (NIA for the criteria of exclusion for subjects who are not to use the EMLA cream);
- Those with skin problem or infection from cut influencing on this clinical study;
- Those with degraded immune function;
- Those with clinically serious problem on cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system or mental disease that significantly influences on this clinical study;
- Those participating in other clinical studies within 30 days from the screening date;
- Those who did not agree to participate in the contraception in the medically allowed methods among female subjects who are able to be pregnant during the clinical study; * Medically allowed contraception method: Condom, oral contraception for more than 6 months, cases of using shot or inserting anti-conceptive or installing conceptive device in the womb;
- Pregnant women or lactating women;
- Other than aforementioned subjects, those with clinical opinion regarding them as inappropriate subjects in this study from the medical judgment from charging person or manager of this study.
About this study
Official title: Randomized, Double-Blind, Single-Center Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects
Intend to prove the non-inferiority of Rejeunesse against the comparing medical device of Restylane Perlane in terms of improvement, efficacy, and safety of nasolabial fold on the face
- Conditions
- Nasolabial Fold Correction
- Being tested
- Rejeunesse, Restylane Perlane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RejeunesseDevice
The clinical medical device, Rejeunesse, is a cross-lined HA hydrogel made by using the cross-linker of 1, 4-butandiol diglycidyl ether (BDDE) with low toxicity from sodium hyaluronate derived from microorganisms. It is a tissue repair biological material in a gel type injected to the skin (thick skin - epidermis and surface of thick skin) near wrinkles on the face for the temporary improvement of wrinkles.
Restylane PerlaneDevice
Restylane Perlane selected as the control group is non-animal stabilized hyaluronic acid (NASHA) originating from bacterial fermentation. It is a tissue repair biomaterial for soft skin [3]. Restylane Perlane is widely used for wrinkle treatment, indented areas and other beauty purposes. Products used in this clinical study can be applied to all types of wrinkles on the face. Stabilized HA constituting the Restylane Perlane is slowly absorbed in the body after combining with water molecules in the skin tissue and is completely absorbed in the skin as a biodegradable substance. Therefore, no residue is left in the body.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Perlane Control Group | Placebo comparator | Not described Receives: Device: Rejeunesse |
| Rejeunesse | Experimental | Not described Receives: Device: Restylane Perlane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Variables
Verify the average value of the difference between Wrinkle Severity Rating Scale (WSRS) between control group and experiment group assessed by the independent evaluator on the 24th week after the final application of medical devices for clinical study Compare the average value of WSRS between control group and experiment group assessed by the independent evaluator on the 24th week after the final application of clinical medical devices. The WSRS is a 5 point scale with 1 being no wrinkles and 5 being extreme wrinkles.
Measured: 24th week after the final application of medical devices for clinical study and assess WSRS.
Secondary outcomes (6)
Average value of Visual Analogue Scale (VAS) between the experiment group and control group within 60 minutes after the final application of clinical medical devices.
Make sure to evaluate the degree of pain on a scale from 0 to 10 that subjects feel in the operation when applying or immediately after applying the clinical medical devices. The Visual Analogue Scale (VAS) is the record of the severest pain on the one side while recording that there is no pain on the other side in the 10cm length of line. 0 is "no pain" and 10 is worst pain possible.
Measured: 60 minutes after the final application of clinical medical devices
Average value of Wrinkle Severity Rating Scale (WSRS) between the experiment group and control group on the 8th week after the final application of clinical medical devices.
Compare the Wrinkle Severity Rating Scale (WSRS) average value between experiment group and control group assessed by the independent evaluator on the 8th week after the final application of clinical medical devices. The WSRS is a 5 point scale with 1 being no wrinkles and 5 being extreme wrinkles.
Measured: 8th week after the final application of clinical medical devices
Average value of global aesthetic improvement scale (GAIS) between control and experiment group assessed by the investigators on the 8th and 24th week after the final application of medical devices before the initial application of medical devices
Compare the average value of GAIS assessed by each investigator on the 8th and 24th week after the final application compared to before the initial application of clinical medical devices
Measured: 8th and 24th week after the final application of medical devices before the initial application of medical devices.
Average value of Global Aesthetic Improvement Scale (GAIS) between control group and experiment group assessed by the investigators on the 8th and 24th week after the final application of medical devices before the initial application of medical devices
Compare the average value of Global Aesthetic Improvement Scale (GAIS) assessed by each investigator on the 8th and 24th week after the final application compared to before the initial application of clinical medical devices. The Global Aesthetic Improvement Scale is a 5 point scale that goes from -1: worse, 0: no change, 1: improved, 2: much improved and 3: very much improved.
Measured: 8th and 24th week after the final application compared to before the initial application of clinical medical devices
Proportion of changes in wrinkle severity rating scale (WSRS) between control group and experiment group on the 24th week after the final application of medical devices compared to before the initial application of medical devices
Compare the control group and experiment group in terms of proportion of WSRS changes assessed by the independent evaluator on the 24th week after the final application compared to before the initial application of clinical medical devices.
Measured: 24th week after the final application compared to before the initial application of clinical medical devices.
Proportion of changes in wrinkle severity rating scale (WSRS) in the experiment group and control group on the 24'h week after the final application of medical devices prior to the initial application of medical devices assessed by the investigator.
Compare the control group and experiment group on the changes in WSRS value assessed by the investigator on the 24th week after the application in comparison to before the initial application of clinical medical devices
Measured: 24th week after the application in comparison to before the initial application of clinical medical devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Feb 2016
- Primary completion12 Sep 2016
- Study completion29 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold CorrectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Hills Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Medic Corporation, Sumin D&C
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770789
- Sponsor's protocol ID
- Rejeunesse-001
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Single-Center Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects
- ClinicalTrials.gov ID
- NCT07770789
- Acronym / sponsor ID
- Rejeunesse-001
- Conditions
- Nasolabial Fold Correction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Forest Hills LabIndustry (pharma, biotech, devices)
- Collaborators
- New Medic Corporation, Sumin D&C
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 29 Nov 2016 (actual)
- First posted
- 18 Aug 2026 (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.
Intend to prove the non-inferiority of Rejeunesse against the comparing medical device of Restylane Perlane in terms of improvement, efficacy, and safety of nasolabial fold on the face
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Perlane Control Group | Placebo comparator | Device: Rejeunesse |
| Rejeunesse | Experimental | Device: Restylane Perlane |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women aged more than 30 but less than 60;
- Those with score 3 or 4 in the wrinkle severity rating scale (WSRS) among those who want the improvement of nasolabial folds;
- Those with visually symmetrical with nasolabial folds;
- Those who agree with the suspension of all the dermatological treatment including the improvement of wrinkle on the face during the clinical study;
- Those who are able to read and follow instructions and participate during the entire period of clinical study;
Key exclusion criteria (19 listed)
- Those with skin sensitiveness on the clinical medical devices according to the result of intradermal test in the screening period;
- Those who were administered with the antithrombotic (I00mg, up to 300mg/day) or anti-steroid anti-inflammatory within 2 days from the screening;
- Those taking the antithrombotic (low-capacity aspirin (100mg, up to 300mg/day) excluded) during the clinical study or abnormal blood coagulation or liver function;
- Those who have used or are scheduled to use the part ointment on the facial surface within 4 weeks from the screening date (steroid, retinoid: only for the medicines and not the cosmetics);
- Those treated for the improvement of wrinkle or pimp within 6 months from the screening date;
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 |
|---|---|---|
| RejeunesseThe clinical medical device, Rejeunesse, is a cross-lined HA hydrogel made by using the cross-linker of 1, 4-butandiol diglycidyl ether (BDDE) with low toxicity from sodium hyaluronate derived from microorganisms. It is a tissue repair biological material in a gel type injected to the skin (thick skin - epidermis and surface of thick skin) near wrinkles on the face for the temporary improvement of wrinkles. | Device | Restylane Perlane Control Group |
| Restylane PerlaneRestylane Perlane selected as the control group is non-animal stabilized hyaluronic acid (NASHA) originating from bacterial fermentation. It is a tissue repair biomaterial for soft skin [3]. Restylane Perlane is widely used for wrinkle treatment, indented areas and other beauty purposes. Products used in this clinical study can be applied to all types of wrinkles on the face. Stabilized HA constituting the Restylane Perlane is slowly absorbed in the body after combining with water molecules in the skin tissue and is completely absorbed in the skin as a biodegradable substance. Therefore, no residue is left in the body. | Device | Rejeunesse |
Primary outcome
Primary Endpoint Variables
Time frame: 24th week after the final application of medical devices for clinical study and assess WSRS.
Verify the average value of the difference between Wrinkle Severity Rating Scale (WSRS) between control group and experiment group assessed by the independent evaluator on the 24th week after the final application of medical devices for clinical study Compare the average value of WSRS between control group and experiment group assessed by the independent evaluator on the 24th week after the final application of clinical medical devices. The WSRS is a 5 point scale with 1 being no wrinkles and 5 being extreme wrinkles.
6 secondary outcomes
Average value of Visual Analogue Scale (VAS) between the experiment group and control group within 60 minutes after the final application of clinical medical devices.
Time frame: 60 minutes after the final application of clinical medical devices
Average value of Wrinkle Severity Rating Scale (WSRS) between the experiment group and control group on the 8th week after the final application of clinical medical devices.
Time frame: 8th week after the final application of clinical medical devices
Average value of global aesthetic improvement scale (GAIS) between control and experiment group assessed by the investigators on the 8th and 24th week after the final application of medical devices before the initial application of medical devices
Time frame: 8th and 24th week after the final application of medical devices before the initial application of medical devices.
Average value of Global Aesthetic Improvement Scale (GAIS) between control group and experiment group assessed by the investigators on the 8th and 24th week after the final application of medical devices before the initial application of medical devices
Time frame: 8th and 24th week after the final application compared to before the initial application of clinical medical devices
Proportion of changes in wrinkle severity rating scale (WSRS) between control group and experiment group on the 24th week after the final application of medical devices compared to before the initial application of medical devices
Time frame: 24th week after the final application compared to before the initial application of clinical medical devices.
Proportion of changes in wrinkle severity rating scale (WSRS) in the experiment group and control group on the 24'h week after the final application of medical devices prior to the initial application of medical devices assessed by the investigator.
Time frame: 24th week after the application in comparison to before the initial application of clinical medical devices
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 18 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rejeunesse and Restylane Perlane in people with Nasolabial Fold Correction, run by Forest Hills Lab.
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 6 inclusion and 19 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary Endpoint Variables (time frame: 24th week after the final application of medical devices for clinical study and assess WSRS.). 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 18 Aug 2026.