Moderate to Severe Glabellar Lines
Conditions
Keywords
YY001, Recombinant Botulinum Toxin Type A, Botulinum Toxin, Glabellar Lines
Brief summary
This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.
Interventions
Five sites will be injected at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.
Sponsors
Chongqing Claruvis Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Intervention model description
Single-arm and long-term follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form. 2. At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs 3. Agree to participate in the study and sign the informed consent form. 4. At the discretion of the investigator, the participants can comply with the protocol requirements. 5. Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the first administration of study drug or a Urine pregnancy test examination must be negative 3 days prior to the first administration of study drug. Note: 1. Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason). 2. Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones \[oral, patch, ring, injections, implants\], barrier methods \[diaphragm, cervical cap, sponge, condom\].
Exclusion criteria
1. Use of medications or treatments prohibited by the REFINE study protocol. 2. Any condition that required permanent discontinuation of study treatment during the REFINE study. 3. Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline. 4. Abnormal laboratory tests that, in the assessment of the investigator, are not appropriate for participation in this study: including, but not limited to: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (×ULN), creatinine ≥ 2 ×ULN, urea/urea nitrogen ≥ 2 ×ULN. 5. Female who is pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events and drug-related adverse events during the study. | Up to 64 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity. | At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. | Glabellar lines at maximal frown are based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe). |
| The proportion of participants who achieve a score of 0 or 1 on the participant's self-assessment and Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site. | At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. | — |
| The respond rate on the investigator's assessment of GL severity at maximal frown. | At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. | The respond rate: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from the baseline, on the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown. |
| The proportion of participants with a decrease of at least 1 grade from the baseline, on the investigator's assessment and the participant's self-assessment individually of GL severity at rest. | At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment. | The severity of glabellar lines at rest will be assessed according to the 4 grade scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe). |
| Incidence of anti-drug antibodies and neutralizing antibodies during the study. | Up to 64 weeks | — |
| The lasting time from a single injection to the participants' score of GL severity at maximal frown on the investigator's assessment return to the baseline. | Up to 64 weeks | — |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYan Wu
Peking University First Hospital
Outcome results
None listed