New wrinkle treatment takes on botox in major trial

NCT ID NCT06585696

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new injection called CU-20101 for moderate to severe frown lines between the eyebrows. It involved 554 adults and compared CU-20101 to Botox, a standard treatment. The goal was to see if CU-20101 works as well and is safe, including with repeated use.

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

554 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 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: * Subjects must meet all of the following inclusion criteria at the same time to be enrolled in the study: 1. After being fully informed, fully aware of the content, process, benefits and possible adverse reactions of the study, and voluntarily participate in the study, and sign the informed consent form; 2. Men or women aged 18-65 years (including boundary values); 3. At screening, the investigator assessed the severity of glabellar lines when the subject tried to frown based on a 4-point FWS, with a score of ≥ 2 points; 4. Subjects self-assessed the severity of glabellar lines when trying to frown based on a 4-point FWS score ≥ 2 points; 5. Subjects were able to communicate well with the investigator and were willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Subjects who met any of the following exclusion criteria were not eligible for enrollment into the study: 1. Subjects with skin abnormalities, including active infections (e.g., herpes simplex, acne, etc.), skin diseases (e.g., psoriasis, eczema, etc.), scars, etc., which may interfere with the study assessment as judged by the investigator; 2. Subjects with diseases that may affect neuromuscular function (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.); or previous history of epilepsy; 3. Previous history of facial paralysis and ptosis; 4. Significant facial asymmetry; 5. Physical stretching methods (e.g., manual stroking of equality) do not reduce eyebrow lines; 6. Subjects allergic to the investigational product and its excipients (e.g., botulinum toxin, serum albumin, etc.); 7. Subjects with prior surgery on the upper face (e.g. eyebrow lifting surgery), autologous fat implantation, semi-permanent or permanent material injection filling or implantation; 8. Subjects who have received botulinum toxin injection of any serum type within 6 months prior to screening; 9. Subjects who have received degradable fillers such as hyaluronic acid, collagen, etc. in the upper facial region within 12 months prior to screening; 10. Subjects who have received intense pulsed light (photon), chemical denudation, etc., within 3 months prior to screening; for partial radiofrequency or high-energy laser treatment, the investigator should extend the interval to 6 months or more according to the actual situation; 11. Subjects who plan to receive other medical aesthetic treatments (e.g., laser, injection tamponade, chemical peeling, etc.) or any treatment that may result in significant weight change (e.g. liposuction surgery, oral weight loss drugs, etc.) or who are expected to require treatment with botulinum toxin of any serum type (other than study intervention) during the study; 12. Subjects taking oral retinoids within 6 months prior to screening or topical retinoids on the face within 3 months prior to screening; 13. Subjects who have used the following systemic drugs within 1 month prior to screening: drugs with muscle relaxant effects (e.g., tubocurarine chloride, dantrolene sodium, baclofen, etc.), aminoglycoside antibiotics (e.g., gentamicin sulfate, neomycin sulfate, etc.), polypeptide antibiotics (e.g., polymyxin B sulfate), tetracycline antibiotics, lincolamides, anticholinergic drugs (e.g., hyoscine butylbromide hydrochloride, benzhexol hydrochloride, etc.), benzodiazepines (e.g., etizolam, etc.), benzamide drugs (e.g., thiopride hydrochloride, sulpiride, etc.); 14. Subjects who have used anticoagulants or non-steroidal anti-inflammatory drugs within 7 days prior to study drug administration; for menstruating subjects, the study drug injection may be delayed as needed to avoid the menstrual period; 15. Pregnant or lactating women; 16. Male or female subjects unwilling to use reliable contraception throughout the trial (except female subjects of non-childbearing potential); 17. According to vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation) and blood pregnancy test at screening, the investigator judged the abnormalities as clinically significant and assessed as not suitable for participation in the investigator; 18. Positive results of any test result for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody; 19. Participation in any clinical trial as a subject within 30 days prior to screening; 20. Subjects with psychiatric disorders that may affect the conduct of the study as judged by the investigator; 21. Previous history of drug or drug abuse; 22. Subjects who are in the acute phase of disease at screening, or have serious systemic diseases, etc., and are judged by the investigator to be ineligible for participation in the study.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, 200443, China

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