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Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

NCT ID: NCT01391312

Last Updated: 2012-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

Brief Summary

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This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

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Detailed Description

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Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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botulinum toxin Type A

Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Group Type ACTIVE_COMPARATOR

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

placebo (Normal Saline)

Normal Saline (placebo) injected into the glabellar region on Day 0.

Group Type PLACEBO_COMPARATOR

normal saline (placebo)

Intervention Type DRUG

Normal saline (placebo) injected into the glabellar region on Day 0.

Interventions

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botulinum toxin Type A

botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Intervention Type BIOLOGICAL

normal saline (placebo)

Normal saline (placebo) injected into the glabellar region on Day 0.

Intervention Type DRUG

Other Intervention Names

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BOTOX® Cosmetic, Vistabel®, Vistabax®

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe glabellar wrinkles (frown lines)

Exclusion Criteria

* Previous treatment with botulinum toxin therapy of any serotype
* Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
* Mid-facial or periorbital treatment with non-permanent soft tissue fillers
* Subjects planning a facial cosmetic procedure or visible scars
* Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* History of facial nerve palsy
* A planned extended absence during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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East Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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GMA-BTXC-11-001

Identifier Type: -

Identifier Source: org_study_id

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