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Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

NCT ID: NCT00888914

Last Updated: 2013-11-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

Detailed Description

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This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.

Conditions

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Lateral Canthal Lines Crow's Feet Facial Wrinkles

Keywords

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Lateral Canthal Lines Crow's Feet Facial Wrinkles

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 A

RT001 Dose A; Active Comparator

Group Type ACTIVE_COMPARATOR

RT001

Intervention Type DRUG

RT001

Dose B

RT001 Dose B; Active Comparator

Group Type ACTIVE_COMPARATOR

RT001

Intervention Type DRUG

RT001

Dose C

RT001 Dose C; Active Comparator

Group Type ACTIVE_COMPARATOR

RT001

Intervention Type DRUG

RT001

Dose D

RT001 Dose D; Active Comparator

Group Type ACTIVE_COMPARATOR

RT001

Intervention Type DRUG

RT001

Dose E

RT001 Dose E; Vehicle Comparator

Group Type PLACEBO_COMPARATOR

Vehicle Comparator

Intervention Type OTHER

Vehicle Comparator

Interventions

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RT001

RT001

Intervention Type DRUG

RT001

RT001

Intervention Type DRUG

RT001

RT001

Intervention Type DRUG

RT001

RT001

Intervention Type DRUG

Vehicle Comparator

Vehicle Comparator

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female or male; 30 to 55 years of age
* Bilateral lateral canthal lines rated as moderate or advanced
* Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening through End of Study
* Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion Criteria

* Muscle weakness or paralysis in the area receiving study treatment
* Active skin disease or irritation at the treatment areas
* Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
* Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
* Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
* Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 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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Richard G. Glogau, MD

San Francisco, California, United States

Site Status

Head and Neck Surgical Group

New York, New York, United States

Site Status

Aesthetic Plastic Surgery

New York, New York, United States

Site Status

Dermatology Surgery and Laser Center

White Plains, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RT001-CL006LCL

Identifier Type: -

Identifier Source: org_study_id