Actively Recruiting
A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet
Led by S.Biomedics Co., Ltd. · Updated on 2025-05-18
80
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
Sponsors
S
S.Biomedics Co., Ltd.
Lead Sponsor
D
Dt&Sanomedics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 19 years and older
- Moderate periorbital wrinkles (at least 3 points on IGA-LCL scale) on both sides in resting state
- Visually symmetrical wrinkles on both sides with matching severity scores
- Agreement to stop all dermatological treatments for facial wrinkles during the study
- Healthy, undamaged skin at sampling areas (behind ears, inside arms, armpits, groin, etc.)
- Blood test results within specified ranges: White Blood Cell count between 4.5x10^3/µl and 11.0x10^3/µl, Platelet count at least 100x10^3/µl, Hemoglobin at least 9 g/dL
- Signed informed consent and willingness to complete follow-up visits during the study period
You will not qualify if you...
- Presence of arterial bleeding or severe variceal bleeding
- Allergy to bovine protein or gentamicin
- Pregnancy, breastfeeding, or planning pregnancy within 6 months
- Women likely to be pregnant or men unwilling to use approved contraception during the trial
- Autoimmune diseases such as myasthenia gravis, lupus, rheumatoid arthritis
- Chronic or active skin diseases or history thereof
- Positive or history of hepatitis C, hepatitis B, HIV-1, or HIV-2 infections (except fully cured hepatitis C)
- Severe heart, liver, or kidney diseases
- Tumors or cancer history within 5 years (with some exceptions)
- Genetic diseases affecting fibroblast or collagen
- Recent or planned anticoagulant or antiplatelet therapy around the study drug administration
- Active skin infections, keloids, unhealed wounds, scars, tumors, or prior radiation at injection site
- Allergy to local anesthetics unless willing to proceed without anesthetic
- History of severe allergic reactions to trial medications
- Recent or planned facial procedures affecting wrinkles during study
- Participation in other clinical trials involving investigational drugs or devices within 6 months
- Prior autologous dermal fibroblast treatments
- History of anaphylaxis or severe complex allergies
- History of keloid, hyperpigmentation, or hypertrophic scars on the face
- Serious disorders of cardiovascular, digestive, respiratory, endocrine, or central nervous systems or significant mental disorders
- Use of systemic corticosteroids within 12 weeks before participation
- Refusal to have photographs taken of the treatment area
- Any other condition judged by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chung-Ang University Hospital
Seoul, South Korea, 156-755
Actively Recruiting
Research Team
S
Sarang Kim, Master's
CONTACT
J
Jong-Wan Kim, Master's
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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