A study to evaluate the efficacy and safety of RBMD-404-01 for the temporary improvement of lateral canthal lines (crow’s feet)

A single-center, randomized, evaluator-subject blind, active controlled, parallel-design, pilot clinical trial to evaluate the efficacy and safety of RBMD-404-01 for both crow's feet

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010835

Enrollment

Registered

2025-08-01

Start date

2025-07-14

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 1. Test Group • Device Name: RBMD-404-01 (RFBio Co., Ltd.) • Composition: Sodium hyaluronate and Polynucleotide sodium • Application Site: Bilateral crow’s feet • Dosage and Administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects aged between 19 and 75 years Subjects with visually symmetrical crow’s feet on both sides of the face Subjects who desire temporary improvement of crow’s feet and have a Crow’s Feet Wrinkle Scale score of =2 on both sides at rest (neutral expression) during screening and baseline Subjects who agree to use appropriate contraception from the date of informed consent until 4 weeks after the final visit Subjects who are able to understand and comply with study instructions and are available for the entire duration of the study Subjects who voluntarily agree to participate in this clinical trial and have signed the written informed consent form

Exclusion criteria

Exclusion criteria: Subjects with abnormal findings in ophthalmologic examinations Subjects with known hypersensitivity to the active components of the investigational device Subjects with active skin diseases, non-healed wounds, or tumors at the application site of the investigational device Subjects with a history of serious cardiovascular, endocrine, neurological disorders, or psychiatric illness Subjects with systemic immune disorders or those currently taking immunosuppressive medications Subjects who have received aesthetic procedures within 24 weeks prior to screening Subjects who have taken immunosuppressants, systemic corticosteroids, or chemotherapy agents within 12 weeks prior to screening Subjects with a history of receiving semi-permanent fillers or permanent skin implants at the target site Subjects who participated in another clinical trial within 30 days prior to screening Pregnant or breastfeeding subjects, or those deemed inappropriate for study participation by the investigator

Design outcomes

Primary

Measure	Time frame
Lateral Canthal Line (LCL) severity scale assessed at rest (neutral expression)	—

Secondary

Measure	Time frame
Crow’s Feet Grading Scale (CFGS) assessed at rest (neutral expression) and during smiling;Global Aesthetic Improvement Scale (GAIS);Adverse events;Visual Analog Scale	—

Countries

Korea, Republic of

Contacts

Public ContactJong Hun Lee

Inje University Sanggye Paik Hospital

joaljh@naver.com+82-2-950-1048

Outcome results