Status:
ACTIVE_NOT_RECRUITING
A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
Lead Sponsor:
Chongqing Claruvis Pharmaceutical Co., Ltd.
Conditions:
Moderate to Severe Glabellar Lines
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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....
Eligibility Criteria
Inclusion
- Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
- At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
- Agree to participate in the study and sign the informed consent form.
- At the discretion of the investigator, the participants can comply with the protocol requirements.
- 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:
- 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).
- Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones \[oral, patch, ring, injections, implants\], barrier methods \[diaphragm, cervical cap, sponge, condom\].
Exclusion
- Use of medications or treatments prohibited by the REFINE study protocol.
- Any condition that required permanent discontinuation of study treatment during the REFINE study.
- Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
- 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.
- Female who is pregnant or breast feeding.
Key Trial Info
Start Date :
March 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2025
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT06583486
Start Date
March 19 2024
End Date
August 20 2025
Last Update
September 4 2024
Active Locations (16)
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1
Guangdong Second People's Hospital
Guangzhou, Guangdong, China
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
3
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China