Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines

NCT ID: NCT01814670

Last Updated: 2019-04-17

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

PHASE4

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-06

Study Completion Date

2014-10-29

Brief Summary

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A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.

Detailed Description

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Conditions

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Glabellar Rhytides

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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botulinum toxin Type A

20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Interventions

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botulinum toxin Type A

20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® onabotulinumtoxinA

Eligibility Criteria

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Inclusion Criteria

* moderate or severe frown lines
* facial laser treatment between 4 to 8 weeks prior to Day 1

Exclusion Criteria

* previous use of botulinum toxin for any indication
* diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
* facial cosmetic procedures within the last 6 Months
* treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
* use of a new topical skin care product within 1 month of the screening
* any prior forehead or periorbital surgery or brow lift
* deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
* any facial skin infection or unhealed skin lesion
* pregnant or breast-feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Beijing, , China

Site Status

Countries

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China

References

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Wu Y, Lu Z, Xie Y, Zhang W, Chen X, Shi Y, Li Q, Halstead M, Rogers JD, Silberberg M. OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study. J Cosmet Laser Ther. 2018 Oct;20(5):278-286. doi: 10.1080/14764172.2017.1406604. Epub 2018 Mar 2.

Reference Type BACKGROUND
PMID: 29498553 (View on PubMed)

Other Identifiers

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AP-BTXC-12-001

Identifier Type: -

Identifier Source: org_study_id

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