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COMPLETED
NCT07770789
PHASE3

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

Sponsor: Forest Hills Lab

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2016-02-15

Completion Date

2016-11-29

Last Updated

2026-08-18

Healthy Volunteers

Yes

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.