Evaluating HG102 for treating moderate to severe glabellar lines compared to Botox
A Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Compare the Efficacy and Safety of HG102 Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
This study is testing a new injection called HG102 to see if it works as well as Botox for treating deep frown lines between the eyebrows in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 272 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Hugel Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05801146 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of HG102, a botulinum toxin type A injection, in treating moderate to severe glabellar lines. The study will compare HG102 to Botox® to determine if it is non-inferior in effectiveness while also evaluating its safety profile. Participants will be adults aged 19 to 65 who exhibit significant glabellar lines and meet specific inclusion criteria. The trial will involve regular visits to monitor outcomes and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 with moderate to severe glabellar lines.
Not a fit: Patients with facial infections, skin diseases, or those who have had similar treatments within the last 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective alternative to Botox® for patients seeking to reduce glabellar lines.
How similar studies have performed: Previous studies have shown positive outcomes with botulinum toxin treatments, suggesting that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects that fit all of the criteria below were selected for this clinical trial. 1. Male and female adults from 19 to 65 years old at the time of screening 2. Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown 3. Person who understands and can comply to the process and visiting schedule of this clinical study 4. Person who gave spontaneous written consent to participate in this clinical study Exclusion Criteria: * Subjects that fit any of the criteria below were excluded from this clinical trial. 1. Person with infection, skin disease, or scar on forehead 2. Person with symptoms of facial palsy or blepharoptosis 3. Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.) 4. Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication) 5. Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods 6. Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer 7. Other person who the investigator judges as inappropriate for the clinical trial
Where this trial is running
Seoul
- Hugel — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Cho Long Park
- Email: clpark@hugel.co.kr
- Phone: +82-2-6966-1654
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.