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
Brief Summary
This study is a phase 1/2 clinical trial to evaluate the safety and efficacy of administering
<br /> clusters of autologous dermal fibroblasts to subjects with periorbital wrinkles on both
<br /> sides.
<br />
<br /> If subjects who have signed the Informed consent form voluntarily are enrolled in this study,
<br /> they will be tested for eligibility during the screening period. Subjects will visit the
<br /> study site a total of 6 times while participating in this study. The subjects who meet the
<br /> inclusion/exclusion criteria will receive a total of one dose of the IP (Visit 3). Then, the
<br /> efficacy evaluation will be conducted at Visit 4 (Week 2), Visit 5 (Week 12), and Visit 6
<br /> (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 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
