Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT04818203
Brief 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.
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:
NCT04818203
Study Brief:
Protocol Section:
NCT04818203