Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

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Detailed Description

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Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Conditions

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Lateral Canthal Lines Crow's Feet Facial Wrinkles

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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RT001

RT001 (Botulinum Toxin Type A) Topical Gel

Group Type EXPERIMENTAL

RT001

Intervention Type DRUG

RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas

Interventions

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RT001

RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study
* Previous treatment with botulinum toxin (any serotype)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes