Treatment for Crow's Feet with HMM1-022
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
This study is testing a new treatment called HMM1-022 to see if it works better than Rejuran for reducing crow's feet around the eyes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 171 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Humedix Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Heukseok-ro, Dongjak-gu) |
| Trial ID | NCT06428253 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of HMM1-022 compared to Rejuran for the temporary correction of crow's feet. It is a single center, subject and evaluator-blind, randomized, matched pairs, active-controlled, confirmatory study. Participants will receive either HMM1-022 or Rejuran, and their outcomes will be assessed to determine the effectiveness of the treatment. The study aims to provide insights into the safety profile and potential benefits of HMM1-022 for cosmetic improvement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 years or older who are seeking treatment for crow's feet and can comply with the study requirements.
Not a fit: Patients with a history of severe allergic reactions, autoimmune diseases, or facial nerve issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for individuals seeking to reduce the appearance of crow's feet.
How similar studies have performed: Other studies have shown success with similar cosmetic treatments, indicating a potential for positive outcomes with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria
* 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
Exclusion criteria
1. Individuals with a history of anaphylaxis or severe allergic diseases that may affect the clinical trial
2. Individuals diagnosed with autoimmune diseases, sarcoid granulomatous pathology, or Osler\'s endocarditis
3. Individuals with hypersensitivity to the investigational medical device, its components (polynucleotide sodium, hyaluronic acid sodium, lidocaine), or other amide-type local anesthetics
4. Individuals with a history of bleeding disorders
5. Individuals with a history of facial nerve paralysis or ptosis
6. Individuals with significant facial asymmetry that may affect the clinical trial
7. Individuals with skin diseases, infections, or abnormalities such as scars in the eye area that could affect the clinical trial
8. Individuals with a history of keloid formation, hyperpigmentation, or hypertrophic scar in the evaluation area
9. 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
10. 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
11. 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)
12. 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
13. 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
14. Individuals with ongoing infectious diseases, including COVID-19, or suspected COVID-19 infection within 2 weeks before screening
15. 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
16. Individuals with positive results for viral tests (HBs Ag, HCV Ab, HIV Ab) performed at Visit 1 (screening) or within 1 month before screening
17. Individuals with a history of alcohol or drug addiction
18. Pregnant or breastfeeding women
19. 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)
20. Individuals deemed unsuitable for participation in the clinical trial based on the investigator\'s judgment
Where this trial is running
Seoul, Heukseok-ro, Dongjak-gu
- Chung-Ang University Hospital — Seoul, Heukseok-ro, Dongjak-gu, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Da Hye Jung
- Email: dhjung@huons.com
- Phone: +82 070-7492-5768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.