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

Crow's Feet Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Crow's Feet

Clinical Trial Details

NCT number	NCT04818203
Study type	Interventional
Source	S.Biomedics Co., Ltd.
Contact	Sarang Kim, Master's
Phone	8207022050023
Email	info@sbiomedics.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 20, 2020
Completion date	June 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01951742` - Dose Finding Study In Subjects With Crow's Feet	Phase 2
Completed	`NCT03326856` - ET-01 in Subjects With Lateral Canthal Lines	Phase 2
Completed	`NCT03839693` - ET-01 in Subjects With Lateral Canthal Lines, LCL-208	Phase 2
Completed	`NCT00888914` - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines	Phase 2
Active, not recruiting	`NCT06021418` - Efficacy and Safety of DKB-119 in Patients in Crow's Feet	N/A
Completed	`NCT01358695` - Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet	Phase 2
Completed	`NCT01124565` - Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults	Phase 2
Completed	`NCT00968825` - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines	Phase 2
Active, not recruiting	`NCT04985916` - ET-01 in Subjects With Lateral Canthal Lines, LCL-210	Phase 2
Completed	`NCT01064518` - Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults	Phase 2
Completed	`NCT03912805` - ET-01 in Subjects With Lateral Canthal Lines, LCL-209	Phase 2
Completed	`NCT00968942` - Efficacy and Safety Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines	Phase 2
Completed	`NCT03655691` - ET-01 in Subjects With Lateral Canthal Lines, LCL-207	Phase 2
Completed	`NCT01124552` - A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.