Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

NCT ID: NCT00856414

Last Updated: 2019-01-29

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)

Detailed Description

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Conditions

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Skin Aging

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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1

botulinum toxin Type A 20U

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)

Interventions

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botulinum toxin Type A

20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Female subjects of any race, 35-55 years of age
* Moderate to severe glabellar wrinkles (lines between the eyebrows)

Exclusion Criteria

* Previous botulinum toxin therapy
* Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
* Subjects planning a facial cosmetic procedure or visible scars
* Previous cosmetic surgery to the upper face
* Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
* History of facial nerve palsy
* Allergy or sensitivity to any component of the study medication
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

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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West Palm Beach, Florida, United States

Site Status

Livonia, Michigan, United States

Site Status

Countries

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United States

References

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Beer KR, Boyd C, Patel RK, Bowen B, James SP, Brin MF. Rapid onset of response and patient-reported outcomes after onabotulinumtoxinA treatment of moderate-to-severe glabellar lines. J Drugs Dermatol. 2011 Jan;10(1):39-44.

Reference Type BACKGROUND
PMID: 21197522 (View on PubMed)

Other Identifiers

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MA-BTX-0806

Identifier Type: -

Identifier Source: org_study_id

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