Crow's FeetPhase 1/2NCT04818203
A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet
A Phase 1/2 study testing Clusters of Autologous Dermal Fibroblasts in people with Crow's Feet, run by S.Biomedics Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Crow's Feet
- What is being tested?
- Clusters of Autologous Dermal Fibroblasts
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2020to 30 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul, 156-755
About this study
Official title: 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 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.
Read the detailed description
This study is a phase 1/2 clinical trial in patients with periorbital wrinkles on both sides. The study consists of phase 1 to evaluate safety and phase 2 to evaluate efficacy.
- Phase 1: Single center, randomized, placebo-controlled, parallel design. If a subject voluntarily signs the written informed consent form to participate in this study, he/she will be enrolled as a subject after eligibility evaluation. After a single administration of the study drug to a subject, safety and efficacy will be evaluated at Week 2, Week 12, and Week 24 visits after administration.
If an adverse drug reaction of grade 3 or higher occurs in 3 subjects 2 weeks after administration of the study drug in the phase 1 study; if an adverse drug reaction occurs in 0/3 subjects, the phase 2 study will be conducted after completing the phase 1 study; if an adverse drug reaction occurs in 2/3 or more subjects, the study will be terminated; and if an adverse drug reaction occurs in 1/3 subjects, 3 additional subjects will be enrolled to proceed with the study. After the safety of subjects in the phase 1 study is confirmed by Week 12, the phase 2 study will be conducted.
- Phase 2: Single center, randomized, subject- and assessor- blinded, placebo controlled, parallel design.
If safety is secured 12 weeks after administering the study drug in phase 1, phase 2 will be conducted.
Only the subjects that meet the final inclusion criteria will be assigned sequentially and recognized by the same procedure and will receive the study drug once.
Safety and efficacy will be evaluated at Week 2, Week 12, Week 24 after administration. All subjects will be tested on the same schedule.
- Conditions
- Crow's Feet
- Being tested
- Clusters of Autologous Dermal Fibroblasts, Placebo
- Keywords
- Fibroblast, Anti-Wrinkle, Cell therapy, Cell spheroid, S.Biomedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clusters of Autologous Dermal FibroblastsBiological
Also called 3D-F, FECS-DF
Dose: 1 x 10^7 cells/1 mL/vial
PlaceboOther
The injection solution without clusters of autologous dermal fibroblasts
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start20 Jul 2020
- Primary completion5 Jul 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's FeetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.Biomedics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dt&Sanomedics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818203
- Sponsor's protocol ID
- SB-FC-001
- Status last verified
- May 2025
- First submitted
- 23 Mar 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04818203
- Acronym / sponsor ID
- SB-FC-001
- Conditions
- Crow's Feet
- Keywords
- Fibroblast, Anti-Wrinkle, Cell therapy, Cell spheroid, S.Biomedics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- S.Biomedics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Dt&Sanomedics
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a phase 1/2 clinical trial in patients with periorbital wrinkles on both sides. The study consists of phase 1 to evaluate safety and phase 2 to evaluate efficacy.
- Phase 1: Single center, randomized, placebo-controlled, parallel design. If a subject voluntarily signs the written informed consent form to participate in this study, he/she will be enrolled as a subject after eligibility evaluation. After a single administration of the study drug to a subject, safety and efficacy will be evaluated at Week 2, Week 12, and Week 24 visits after administration.
If an adverse drug reaction of grade 3 or higher occurs in 3 subjects 2 weeks after administration of the study drug in the phase 1 study; if an adverse drug reaction occurs in 0/3 subjects, the phase 2 study will be conducted after completing the phase 1 study; if an adverse drug reaction occurs in 2/3 or more subjects, the study will be terminated; and if an adverse drug reaction occurs in 1/3 subjects, 3 additional subjects will be enrolled to proceed with the study. After the safety of subjects in the phase 1 study is confirmed by Week 12, the phase 2 study will be conducted.
- Phase 2: Single center, randomized, subject- and assessor- blinded, placebo controlled, parallel design.
If safety is secured 12 weeks after administering the study drug in phase 1, phase 2 will be conducted.
Only the subjects that meet the final inclusion criteria will be assigned sequentially and recognized by the same procedure and will receive the study drug once.
Safety and efficacy will be evaluated at Week 2, Week 12, Week 24 after administration. All subjects will be tested on the same schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: Clusters of Autologous Dermal FibroblastsParticipants 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.)
Key exclusion criteria (23 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clusters of Autologous Dermal FibroblastsAlso: 3D-F, FECS-DFDose: 1 x 10^7 cells/1 mL/vial | Biological | Test Group |
| PlaceboThe injection solution without clusters of autologous dermal fibroblasts | Other | Placebo |
Primary outcome
Improvement rate of 2 points or more of IGA-LCL Wrinkle Severity
Time frame: Baseline, Week 24
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
Related trials for Crow's Feet
RecruitingObservational study
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Perioral Wrinkles, Crow's Feet
Not yet recruitingPhase 4
A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines
Not yet recruitingPhase 3
A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)
Intentional Correction of Forehead Wrinkles (crow's Feet)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clusters of Autologous Dermal Fibroblasts in people with Crow's Feet, run by S.Biomedics Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarang Kim, Master's (8207022050023, info@sbiomedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of 2 points or more of IGA-LCL Wrinkle Severity (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.