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Botox study targets wrinkles in japan – phase 3 complete

NCT ID NCT06794866

Symptom relief Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested Botox (onabotulinumtoxinA) in 150 Japanese adults with moderate to severe forehead lines. Participants received injections of either Botox or a placebo and were followed for up to 12 months. The goal was to see if Botox safely reduces 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
OnabotulinumtoxinA (Botox)
What this could lead to
If it works, this could provide a safe and effective option for reducing forehead wrinkles in Japanese adults.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Placebo group means some may not benefit, and side effects like bruising or temporary muscle weakness are possible.

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

150 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

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: * Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment. * Glabellar lines (GL) of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment. * Good health as per the investigator's judgment based on medical history, abbreviated physical examination and vital sign measurements, including no known active pandemic infection (e.g., severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\]). Exclusion Criteria: * FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1 prior to study treatment. * History of known immunization or hypersensitivity to any botulinum neurotoxin serotype. * History of treatments to the mid or upper face.

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As listed by the trial registrant

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

Forehead lines

Contacts and locations

Locations

  • Akihabara Skin Clinic /ID# 268441

    Tokyo, 101-0021, Japan

  • Chiharu Dermatology Clinic Urawa /ID# 268497

    Saitama, 333-0055, Japan

  • Forest Palace Dermatology Clinic /ID# 268599

    Nerima-ku, Tokyo, 177-0041, Japan

  • Ginza Skin Clinic /ID# 268532

    Chuo-ku, Tokyo, 104-0061, Japan

  • Greenwood Skin Clinic Tachikawa /ID# 268528

    Tachikawa-shi, Tokyo, 190-0023, Japan

  • Hiroshima Station Clinic /ID# 268467

    Hiroshima, Hiroshima, 732-0053, Japan

  • Jun Clinic /ID# 268531

    Nagano, Nagano, 380-0826, Japan

  • Kitasato University Kitasato Institute Hospital /ID# 268499

    Minato-ku, Tokyo, 108-8642, Japan

  • Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460

    Sapporo, Hokkaido, 063-0812, Japan

  • Queens Square Medical Center, Dermatology and Allergology /ID# 268454

    Yokohama, Kanagawa, 220-6208, Japan

  • Tokai University Hospital /ID# 268496

    Isehara, Kanagawa, 259-1193, Japan

  • Tokyo Asbo Clinic /ID# 268529

    Chuo-ku, Tokyo, 104-0031, Japan

  • Tokyo Center Clinic /ID# 268477

    Chuo-ku, Tokyo, 103-0027, Japan

  • Touyama Plastic Surgery Clinic /ID# 268456

    Naha, Okinawa, 900-0015, Japan

  • Yoshikawa Skin Clinic /ID# 268494

    Takatsuki, Osaka, 569-0824, Japan

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