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.
Participants of ages 19 and older
Those with at least 3 points (Moderate) of the IGA-LCL severity scale on both sides in the rest state during screening
Those who have visually symmetrical periorbital wrinkles on both sides and have the same IGA-LCL severity scale score in the rest state
Those who agreed to discontinue all dermatological treatments including facial wrinkle improvement during this study period
Those with arterial bleeding or severe variceal bleeding in the body
Those with hypersensitivity to bovine protein or gentamicin
Pregnant and breast-feeding or who planning to conceive within six months of clinical trial medication
Out of who are pregnant or breast-feeding and A woman who is likely to be pregnant in a postmenopausal or a state of non-Infertility surgery and men with reproductive abilities not willing or planning to use the appropriate contraception defined in this clinical trial during their participation in clinical trials
Parallel
Clusters of Autologous Dermal Fibroblasts
Biological/VaccineDose: 1 x 10\^7 cells/1 mL/vial
Placebo
Other interventionThe injection solution without clusters of autologous dermal fibroblasts
Improvement rate of 2 points or more of IGA-LCL Wrinkle Severity
After independent assessment of IGA-LCL (Investigator's Global Assessment of Lateral Canthal Lines) Wrinkle Severity of the subject's left/right crow's feet in the rest state assessed through photographs, the percentage of subjects who improved by 2 points or more on both sides compared to the baseline are presented by group
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S.Biomedics Co., Ltd.
Lead sponsor
Dt&Sanomedics
Collaborator
