BOTOX® in the Treatment of Upper Facial Lines in Japan

NCT ID: NCT01797094

Last Updated: 2015-02-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).

Detailed Description

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Conditions

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Upper Facial Rhytides Crow's Feet Lines Glabellar Lines Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botulinum toxin Type A (44U)

44 units (U) botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.

Group Type EXPERIMENTAL

botulinum toxin Type A (44U)

Intervention Type BIOLOGICAL

44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.

Botulinum toxin Type A (32U)

32 units (U) botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.

Group Type EXPERIMENTAL

botulinum toxin Type A (32U)

Intervention Type BIOLOGICAL

32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.

Interventions

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botulinum toxin Type A (44U)

44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.

Intervention Type BIOLOGICAL

botulinum toxin Type A (32U)

32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® BOTOX®

Eligibility Criteria

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Inclusion Criteria

-Moderate to severe Crow's Feet Lines and Frown Lines

Exclusion Criteria

* Current or previous botulinum toxin treatment of any serotype
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
* Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
* Medium-depth or deep facial peels within 5 years
* Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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191622-122

Identifier Type: -

Identifier Source: org_study_id

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