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Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults

NCT00884234•Revance Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.

Detailed Description

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).

Eligibility

Age

30 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Female/male ages 30 to 55
•2. Bilateral lateral canthal lines rated as moderate or advanced.
•3. Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
•4. Women of child baring potential must practice and be willing to continue to use an effective method of birth control.

Exclusion Criteria

•1. Muscle weakness or paralysis in the area receiving treatment.
•2. Active skin disease or irritation at treatment areas.
•3. Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
•4. Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
•5. Use of 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 (Week 6).
•6. Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.

Locations (1)

Suzanne Bruce & Associates / The Center for Skin Research

Houston, Texas, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

April 1, 2009

Completion Date

June 1, 2009

Last Updated

August 28, 2020

Enrollment

ACTUAL participants

Conditions

Lateral Canthal Lines

Interventions

Vehicle Control

OTHER

RT001 (Botulinum Toxin Type A Topical Gel)

DRUG

ET-01 in Subjects With Lateral Canthal Lines, LCL-210

NCT04985916

Lateral Canthal Lines, LCLCrow's Feet

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COMPLETEDPHASE2

Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

NCT03911102

Lateral Canthal Lines

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ET-01 in Subjects With Lateral Canthal Lines, LCL-210

Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

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