Crow's FeetNCT06428253
Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet
A study testing HMM1-022 in people with Crow's Feet, run by Humedix Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Crow's Feet
- What is being tested?
- HMM1-022
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2024to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
- Within 6 months before Visit 1 (screening) undergoing invasive laser, deep dermabrasion, or other procedures or surgeries related to wrinkle treatment in the eye area
- Insertion of permanent skin expansion implants like Softform or silicone in the eye area before screening
- Starting or receiving a new oral or topical anti-wrinkle medication with wrinkle prevention effects within 3 months before Visit 1 (screening)
- Individuals who have undergone the following drug therapies that could affect the evaluation of the investigational medical device:
- Use of NSAIDs, antiplatelet agents, anticoagulants, immunosuppressants within 2 weeks before Visit 1 (screening), or required during the clinical trial period (excluding low-dose aspirin (100 mg, up to 300 mg/day))
- Use of topical agents (steroids, retinoids: only medications, not cosmetics) in the eye area within 1 month before Visit 1 (screening) or planned use during the clinical trial
- Individuals who have received a COVID-19 vaccine within 3 weeks before the application of the investigational medical device or are planned to receive it within 4 weeks after application
- Individuals with ongoing infectious diseases, including COVID-19, or suspected COVID-19 infection within 2 weeks before screening
- Individuals who have been administered or undergone other investigational drugs or devices within 1 month before Visit 1 (screening), or within 6 months for studies related to crow's feet wrinkles
- Individuals with positive results for viral tests (HBs Ag, HCV Ab, HIV Ab) performed at Visit 1 (screening) or within 1 month before screening
- Individuals with a history of alcohol or drug addiction
- Pregnant or breastfeeding women
- Individuals planning to become pregnant during the clinical trial or those who, along with their partners (or spouses), do not agree to use medically acceptable contraception methods (examples include: hormonal contraceptives, proven failure rates intrauterine devices (IUDs), double barrier methods, sterilization)
- Individuals deemed unsuitable for participation in the clinical trial based on the investigator\'s judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chung-Ang University Hospital
Seoul, Heukseok-ro, Dongjak-gu, 06973
About this study
Official title: 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
The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet
Read the 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
- Conditions
- Crow's Feet
- Being tested
- HMM1-022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMM1-022Device
intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HMM1-022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (5)
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 8, 10 weeks after initial injection
Measured: 8, 10 weeks
Change in GAIS scores assessed by an independent evaluator
Change in GAIS scores assessed by an independent evaluator at 8, 10, 18 weeks after initial injection
Measured: 8, 10, 18 weeks
Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator
Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator at 8, 10, 18 weeks after initial injection
Measured: 8, 10, 18 weeks
Change in GAIS scores assessed by the subject
Change in GAIS scores assessed by the subject at 8, 10, 18 weeks after initial injection
Measured: 8, 10, 18 weeks
Improvement rate of GAIS for both crow's feet as assessed by the subject
Improvement rate of GAIS for both crow's feet as assessed by the subject at 8, 10, 18 weeks after initial injection
Measured: 8, 10, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start14 May 2024
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's FeetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humedix Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon Kim, M.D., Study director, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428253
- Sponsor's protocol ID
- HMM1-022
- Status last verified
- Dec 2025
- First submitted
- 20 May 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06428253
- Acronym / sponsor ID
- HMM1-022
- Conditions
- Crow's Feet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Humedix Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMM1-022 | Experimental | Device: HMM1-022Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals. |
| REJURAN® | Active comparator | Device: HMM1-022Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMM1-022intradermal injection | Device | HMM1-022, REJURAN® |
Primary outcome
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators
Time frame: 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
5 secondary outcomes
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators
Time frame: 8, 10 weeks
Change in GAIS scores assessed by an independent evaluator
Time frame: 8, 10, 18 weeks
Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator
Time frame: 8, 10, 18 weeks
Change in GAIS scores assessed by the subject
Time frame: 8, 10, 18 weeks
Improvement rate of GAIS for both crow's feet as assessed by the subject
Time frame: 8, 10, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Crow's Feet
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Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
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A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines
RecruitingPhase 1/2
A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet
Crow's Feet
Not yet recruitingPhase 3
A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)
Intentional Correction of Forehead Wrinkles (crow's Feet)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beom Joon Kim, M.D. study director
Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMM1-022 in people with Crow's Feet, run by Humedix Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.