Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet

Crows Feet Clinical Trial

Official title:

A Single Center, Subject & Evaluator-blind, Randomized, Matched Pairs, Active-controlled, Confirmatory Study to Evlualte the Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428253
• Other study ID #: HMM1-022
• Status: Recruiting
• Phase: Phase 3
• Start date: May 14, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Humedix Co., Ltd.
• Contact: development Humedix
• Phone: 82-70-7492-5647
• Email: dhs[@]humedix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 171
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Crows feet (both eyes) is at least 3 points (Moderate) on the lGA-LCL severity scale, and the wrinkles are symmetrical by the investigator

Related Conditions & MeSH terms

• Crows Feet

Intervention

Device:
• HMM1-022
intradermal injection

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul	Heukseok-ro, Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Humedix Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGA-LCL severity scale	Compared to Rejuran, the improvement rate on the crow's feet at rest evaluation scale (IGA-LCL severity scale) by external independent evaluators to prove that HMM1-022 is non-inferior	18 weeks after initial inejction