drugset / Trial / NCT04818203

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

NCT04818203 ↗

Phase 1/2 Recruiting 80 enrolled S.Biomedics Co., Ltd. Dt&Sanomedics · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-07-20
Primary completion
2025-07-05
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Clusters of Autologous Dermal Fibroblasts Unknown 1e+07 cells —

Indications

No indication recorded.