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Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects
Sponsor: Forest Hills Lab
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
Conditions
Interventions
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.
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.