Evaluating the effectiveness and safety of autologous dermal fibroblasts for treating 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

This study is testing if a new treatment using your own skin cells can safely reduce crow's feet for people who want to improve their appearance.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: S.Biomedics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT04818203 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of clusters of autologous dermal fibroblasts in patients with bilateral crow's feet. Participants will undergo a screening process to determine eligibility and will receive a single dose of the treatment, followed by evaluations at multiple time points over 24 weeks. The study is designed in two phases: Phase 1 focuses on safety, while Phase 2 evaluates efficacy, using a randomized, placebo-controlled approach. Participants will visit the study site six times throughout the trial for assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with moderate crow's feet and symmetrical periorbital wrinkles.

Not a fit: Patients with severe skin conditions or those currently undergoing dermatological treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for reducing crow's feet and improving skin appearance.

How similar studies have performed: While similar approaches have been explored, this specific application of autologous dermal fibroblasts for crow's feet is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Those who participated in another study and received an investigational drug or used an investigational medical device within 6 months prior to participation in this study, or those who are scheduled to participate in another study during this study period
* Those with a medical history of autologous dermal fibroblast treatment
* Those with a medical history of anaphylaxis or severe complex allergies
* Those with a medical history of keloid formation, hyperpigmentation, or hypertrophic scars on the face
* Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, or central nervous system, or have had or currently have a mental disorder that significantly affects this study
* Those who received systemic corticosteroid within 12 weeks prior to participation in this study
* Those who refuse to take pictures of the site where the study drug is administered
* Those who are judged to be ineligible by the investigator to participate in this study for other reasons

Where this trial is running

Seoul

• Chung-Ang University Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Sarang Kim, Master's

Conditions Crow's Feet; Fibroblast; Anti-Wrinkle; Cell therapy; Cell spheroid; S.Biomedics