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Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects

NCT07770789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-08-18

No results posted yet for this study

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

Conditions

  • Nasolabial Fold Correction

Interventions

DEVICE

Rejeunesse

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.

DEVICE

Restylane Perlane

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.

Sponsors & Collaborators

  • New Medic Corporation

    collaborator UNKNOWN

  • Sumin D&C

    collaborator UNKNOWN

  • Forest Hills Lab

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-15
Primary Completion
2016-09-12
Completion
2016-11-29

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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 NCT07770789 on ClinicalTrials.gov