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

NCT04818203 | Recruiting Phase 1

• 1 other identifier: SB-FC-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crow's Feet

Keywords

Fibroblast; Anti-Wrinkle; Cell therapy; Cell spheroid; S.Biomedics

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Week 24

Study Arms (2)

Test Group

EXPERIMENTAL

Participants receive 1 mL of clusters of autologous dermal fibroblast to three spots around the left eye and three spots around the right eye along the periorbital wrinkles on both sides, perpendicularly to the wrinkles.

Biological: Clusters of Autologous Dermal Fibroblasts

Placebo

PLACEBO COMPARATOR

Participants receive 1 mL of placebo solution to three spots around the left eye and three spots around the right eye along the periorbital wrinkles on both sides, perpendicularly to the wrinkles.

Other: Placebo

Interventions

Clusters of Autologous Dermal Fibroblasts BIOLOGICAL

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

Also known as: 3D-F, FECS-DF

Test Group

Placebo OTHER

The injection solution without clusters of autologous dermal fibroblasts

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects with healthy and undamaged skin at the sampling area (e.g., behind the ears, inside of the arms, armpits, groin, etc.)
• Those who meet the following criteria based on the blood test at screening or baseline visits
• White Blood Cell : ≥4.5x10\^3/μl and ≤11.0x10\^3/μl
• Platelet count : ≥100x10\^3/μl
• Hemoglobin : ≥9 g/dL
• Those who sign the written consent form after hearing the explanation of the purpose, method, and efficacy of this study
• Those who can be followed up during the study period

You may not qualify if:

• 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
• Those with or suspected of having autoimmune diseases (e.g., myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, etc.)
• At the screening visit, patients with chronic skin disease or such a medical history
• Those with a medical history or a positive test result for any of the following: hepatitis C virus antibody (HCV Ab), hepatitis B surface antigen (HBsAg), human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody (However, if HCV is proven to be completely cured based on the HCV RNA test, he/she can be enrolled as a subject.)
• Those with severe heart diseases (e.g., myocardial infarction, heart failure, etc.) or severe liver diseases (e.g., hepatocirrhosis, liver failure, etc.) or severe kidney diseases (e.g., renal failure, etc.)
• Those who have tumors or have such medical history within 5 years of screening (However, if the malignant tumor does not relapse for more than 5 years, the candidate may be enrolled as a subject, and in the case of basal cell carcinoma or intradermal squamous cell carcinoma that does not relapse after resection, he/she can be enrolled as a subject.)
• Those with genetic diseases affecting fibroblast or collagen
• Those who have undergone anticoagulant therapy or antiplatelet therapy within 10 days prior to administration of the study drug, or those who are expected to need to receive them within 3 days after administration of the study drug (However, if the drug is being administered at the time of screening, it is possible to participate in the clinical trial after a seven-day not administering medication period only if the temporary suspension does not pose a medical risk under the tester's judgment, tried tissue biopsy Schedule.)
• Those who have active or infectious skin diseases (skin infection, inflammation, herpes, etc.), keloids, unhealed wounds or scars, tumors, etc. at the site where the study drug will be administered, or those who have previously received radiation treatment
• Those with hypersensitivity to local anesthetics (however, those who agree to receive the procedure without applying an anesthetic agent due to hypersensitivity to local anesthetics, do not fall under this criteria.)
• A person who has a history of significant adverse or hypersensitive reactions to the composition of medications for clinical trials
• Those who have undergone procedures that can affect periorbital wrinkles, such as dermabrasion, skin regeneration, and plastic surgery, etc, among facial procedures including the eye area\* or those who are expected to have such procedures during the study period

Sponsors & Collaborators

• S.Biomedics Co., Ltd.: lead
• Dt&Sanomedics: collaborator

Study Sites (1)

Chung-Ang University Hospital

Seoul, 156-755, South Korea

RECRUITING

Central Study Contacts

Sarang Kim, Master's

CONTACT

8207022050023; info@sbiomedics.com

Jong-Wan Kim, Master's

CONTACT

8207022050023; jwkim@sbiomedics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: July 20, 2020
• Primary Completion: July 5, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

KR (1)