Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

NCT ID: NCT01940991

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines

Detailed Description

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Conditions

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Skin Aging

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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Dose B

Dose B: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, Dose B; dose applied to the lateral canthal lines

Dose A

Dose A: Botulinum Toxin Type A

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines

Interventions

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Placebo

Placebo, Dose B; dose applied to the lateral canthal lines

Intervention Type DRUG

Botulinum Toxin Type A

Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe crow's feet lines
* Female or male, 18 to 65 years of age and in good general health
* Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation at the treatment area
* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
* Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revance Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermatology Research Institute

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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RT001-CL035

Identifier Type: -

Identifier Source: org_study_id