## Protocol Section
### Identification Module
**NCT ID:** NCT06428253

**Brief Title:** Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet

**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

#### Organization Study ID Info
**ID:** HMM1-022
#### Organization
**Class:** INDUSTRY
**Full Name:** Humedix Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Humedix Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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 Module

**Conditions:**

- Crows Feet

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** subject/evaluator blinding

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 171

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: HMM1-022

**Label:** HMM1-022

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Device: HMM1-022

**Label:** REJURAN®

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HMM1-022

- REJURAN®

**Description:** intradermal injection

**Name:** HMM1-022

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** IGA-LCL severity scale

**Time Frame:** 18 weeks after initial inejction

### Eligibility Module

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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dhs@humedix.com

**Name:** development Humedix

**Phone:** 82-70-7492-5647

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** beomjoon74@gmail.com

- **Name:** Beom Joon Kim, M.D

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Chung-Ang University Hospital

**State:** Heukseok-ro, Dongjak-gu

**Status:** RECRUITING

**Zip:** 06973

#### Overall Officials

**Official 1:**

**Affiliation:** Dermatology

**Name:** Beom-joon Kim, M.D.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
