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New Botox-Like injection aims to smooth frown lines safely

NCT ID NCT06583486

Symptom relief Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests a new form of botulinum toxin (YY001) for treating moderate to severe frown lines between the eyebrows. About 488 adults aged 18 to 65 will receive repeated injections over time. Researchers will monitor safety, side effects, and how well the treatment works to reduce wrinkle severity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
recombinant botulinum toxin type A (YY001)
What this could lead to
If successful, this could provide a safe and effective option for reducing frown lines with repeated treatments.
What could go wrong
This is a cosmetic treatment, not a cure for any disease. Side effects may include injection site reactions or temporary muscle weakness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

488 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe glabellar lines

Contacts and locations

Locations

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

    Hangzhou, Zhejiang, China

  • Beijing Tsinghua Changgung Hospital

    Beijing, China

  • Guangdong Second People's Hospital

    Guangzhou, Guangdong, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • Peking Union Medical College Hospital , Chinese Academy of Medical Sciences

    Beijing, China

  • Peking University First Hospital

    Beijing, China

  • Peking University Third Hospital

    Beijing, China

  • Plastic Surgery Hospital, Chinese Academy of Medical Science

    Beijing, China

  • The First Affiliated Hospital of Chongqing Medical University

    Hongqing, China

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xian, Shanxi, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Medical University General Hospital

    Tianjin, China

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

    Wuhan, Hubei, China

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

    Chengdu, Sichuan, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

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