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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 | Clinical Trials | Clareo Health

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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

A Multi-center, Open-label 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

NCT06583486•Chongqing Claruvis Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (16)

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xian, Shanxi, China

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, China

Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Beijing Tsinghua Changgung Hospital

Beijing, China

Key Dates

Start Date

March 19, 2024

Primary Completion Date

August 20, 2025

Completion Date

August 20, 2025

Last Updated

September 4, 2024

Enrollment

488

ACTUAL participants

Conditions

Moderate to Severe Glabellar Lines

Interventions

Rcombinant botulinum neurotoxin type A for injection (YY001)

BIOLOGICAL

A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

NCT06481475

Moderate to Severe Glabellar Lines

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COMPLETEDPHASE1

Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines

NCT06151561

Moderate to Severe Glabellar Lines

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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