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

NCT06428253 | Completed

• 1 other identifier: HMM1-022
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crow's Feet

Outcome Measures

Primary Outcomes (1)

• Improvement rate of IGA-LCL wrinkle severity by external independent evaluators

  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

  18 weeks

Secondary Outcomes (5)

• Improvement rate of IGA-LCL wrinkle severity by external independent evaluators

  8, 10 weeks

• Change in GAIS scores assessed by an independent evaluator

  8, 10, 18 weeks

• Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator

  8, 10, 18 weeks

• Change in GAIS scores assessed by the subject

  8, 10, 18 weeks

• Improvement rate of GAIS for both crow's feet as assessed by the subject

  8, 10, 18 weeks

Study Arms (2)

HMM1-022

EXPERIMENTAL

Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.

Device: HMM1-022

REJURAN®

ACTIVE COMPARATOR

Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.

Device: HMM1-022

Interventions

HMM1-022 DEVICE

intradermal injection

HMM1-022; REJURAN®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 19 years or older
• Individuals who have voluntarily decided to participate in the clinical trial after receiving and understanding a detailed explanation, and who have provided written consent
• Individuals who have agreed to discontinue all dermatological treatments, including wrinkle treatments around the eyes, during the clinical trial period

You may not qualify if:

• Individuals with a history of anaphylaxis or severe allergic diseases that may affect the clinical trial
• Individuals diagnosed with autoimmune diseases, sarcoid granulomatous pathology, or Osler\'s endocarditis
• Individuals with hypersensitivity to the investigational medical device, its components (polynucleotide sodium, hyaluronic acid sodium, lidocaine), or other amide-type local anesthetics
• Individuals with a history of bleeding disorders
• Individuals with a history of facial nerve paralysis or ptosis
• Individuals with significant facial asymmetry that may affect the clinical trial
• Individuals with skin diseases, infections, or abnormalities such as scars in the eye area that could affect the clinical trial
• Individuals with a history of keloid formation, hyperpigmentation, or hypertrophic scar in the evaluation area
• Individuals with a history of malignant tumors within 5 years prior to Visit 1 (screening), except those with treated basal cell or squamous cell skin cancer not in the eye area, or treated cervical cancer
• Individuals with clinically significant disorders or psychiatric conditions affecting the cardiovascular, gastrointestinal, respiratory, endocrine, immune, or central nervous systems, or those with conditions that may significantly impact the clinical trial
• Individuals who have undergone or are scheduled to undergo treatments affecting the efficacy assessment of crow's feet wrinkles during the following periods:
• Within 24 months before Visit 1 (screening) using Poly(L-Lactide) or Poly(ε-Caprolactone) for wrinkle treatment
• Within 18 months before Visit 1 (screening) using Calcium hydroxylapatite (CaHA) for wrinkle treatment
• Within 12 months before Visit 1 (screening) using hyaluronic acid for wrinkle treatment
• Within 6 months before Visit 1 (screening) using collagen, botulinum toxin, or other wrinkle treatments

Sponsors & Collaborators

• Humedix Co., Ltd.: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, Heukseok-ro, Dongjak-gu, 06973, South Korea

Location

Study Officials

• Beom Joon Kim, M.D.

  Dermatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: subject/evaluator blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: May 14, 2024
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)