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RECRUITING
NCT04818203
PHASE1/PHASE2

A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet

Sponsor: S.Biomedics Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a phase 1/2 clinical trial to evaluate the safety and efficacy of administering clusters of autologous dermal fibroblasts to subjects with periorbital wrinkles on both sides. If subjects who have signed the Informed consent form voluntarily are enrolled in this study, they will be tested for eligibility during the screening period. Subjects will visit the study site a total of 6 times while participating in this study. The subjects who meet the inclusion/exclusion criteria will receive a total of one dose of the IP (Visit 3). Then, the efficacy evaluation will be conducted at Visit 4 (Week 2), Visit 5 (Week 12), and Visit 6 (Week 24), and safety will also be evaluated at each visit.

Official title: A Single Center, Randomized, Evaluator and Subject Blind, Placebo Controlled, Parallel, Phase 1/2 Study for the Anti-wrinkle Efficacy Assessment and Safety Evaluation by Treating Cluster of Autologous Dermal Fibroblasts, 3D-F in Patients With Bilateral Crow's Feet

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2020-07-20

Completion Date

2026-06-30

Last Updated

2025-05-18

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Clusters of Autologous Dermal Fibroblasts

Dose: 1 x 10\^7 cells/1 mL/vial

OTHER

Placebo

The injection solution without clusters of autologous dermal fibroblasts

Locations (1)

Chung-Ang University Hospital

Seoul, South Korea