RecruitingPhase 1Phase 2NCT04818203

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

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


Sponsor

S.Biomedics Co., Ltd.

Enrollment

80 participants

Start Date

Jul 20, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This South Korean study tests whether an injection of a cluster of the patient's own skin cells (autologous dermal fibroblasts) into the skin around the eyes can reduce crow's feet wrinkles. Fibroblasts are skin cells that produce collagen, and researchers believe that injecting them where collagen has diminished over time may restore a more youthful appearance. Participants will have a small skin sample taken from an inconspicuous area of the body, and their fibroblasts will be grown in a laboratory before being injected. The study compares this treatment to a placebo injection to see whether the results are genuinely due to the cells. You may be eligible if: - You are 19 years of age or older - You have moderate to severe crow's feet wrinkles on both sides of your face - You have healthy skin at the tissue harvest site - Your blood counts and overall health meet the study requirements You may NOT be eligible if: - You are pregnant, breastfeeding, or planning to conceive within 6 months - You have an autoimmune disease (e.g., lupus, rheumatoid arthritis) - You have a history of severe cardiac, liver, or kidney disease - You have had a tumor or cancer within the past 5 years - You have received systemic corticosteroids in the past 12 weeks - You have had prior autologous fibroblast therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALClusters of Autologous Dermal Fibroblasts

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

OTHERPlacebo

The injection solution without clusters of autologous dermal fibroblasts


Locations(1)

Chung-Ang University Hospital

Seoul, South Korea

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NCT04818203


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