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NOT YET RECRUITING
NCT07912814

Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique

Sponsor: PharmaResearch Co.,Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to learn whether DOT PN (Rejuran S), a polynucleotide injectable gel, improves periorbital hollowing (a sunken look around the eyes) in adults aged 25 to 65 years when injected into the deep layer around the eyes with a blunt cannula. Safety will also be assessed. The main question it aims to answer is: \- How much do tear trough depth and brow height change from baseline to Week 16, as measured by 3D imaging? There is no comparison group. All participants receive the study treatment. Participants will: * Receive injections around both eyes (4.0 mL in total per visit) at Weeks 0, 4, 8, and 12 * Have 3D facial photographs taken and report side effects at each visit * Return for follow-up visits at Weeks 16, 20, and 24.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-12-07

Completion Date

2027-10-30

Last Updated

2026-11-03

Healthy Volunteers

Yes

Interventions

DEVICE

DOT PN (Rejuran S)

Sterile injectable gel containing 20 mg/mL sodium polynucleotide (1 mL pre-filled syringe). Injected into the periorbital deep (sub-SMAS) plane using a 25G blunt cannula (study-specific technique; the supplied 30G needle is not used), with entry points created by a 23G needle at three sites (ROOF, SOOF, and tear trough), using a linear retrograde and fanning technique. Dose: 2.0 mL per side (4.0 mL per session) at Weeks 0, 4, 8, and 12.

Locations (3)

MX Clinic Bangsar

Kuala Lumpur, Malaysia

J Laser and Aesthetic Clinic

Singapore, Singapore

Dr. Atchima

Bangkok, Thailand