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

Phase 3

Recruiting

• Conditions: Crow's Feet
• Interventions: Device: HMM1-022

• Registration Number: NCT06428253
• Lead Sponsor: Humedix Co., Ltd.

Brief Summary

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

Detailed Description

A single center, subject \& evaluator-blind, randomized, matched pairs, active-controlled, confirmatory study to evaluate the efficacy and safety of HMM1-022 in temporary correction of Crow's feet

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-14
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMM1-022	HMM1-022	Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.
REJURAN®	HMM1-022	Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.

Primary Outcome Measures

Name	Time	Method
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators	18 weeks	Improvement rate of 1 point or more on the crow's feet at rest IGA-LCL severity scale by external independent evaluators at 18 weeks after initial injection

Secondary Outcome Measures

Name	Time	Method
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators	8, 10 weeks	Improvement rate of 1 point or more on the crow's feet at rest IGA-LCL severity scale by external independent evaluators at 8, 10 weeks after initial injection
Change in GAIS scores assessed by an independent evaluator	8, 10, 18 weeks	Change in GAIS scores assessed by an independent evaluator at 8, 10, 18 weeks after initial injection
Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator	8, 10, 18 weeks	Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator at 8, 10, 18 weeks after initial injection
Change in GAIS scores assessed by the subject	8, 10, 18 weeks	Change in GAIS scores assessed by the subject at 8, 10, 18 weeks after initial injection
Improvement rate of GAIS for both crow's feet as assessed by the subject	8, 10, 18 weeks	Improvement rate of GAIS for both crow's feet as assessed by the subject at 8, 10, 18 weeks after initial injection

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Heukseok-ro, Dongjak-gu, Korea, Republic of