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

August 20, 2020 updated by: Revance Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77056
        • Suzanne Bruce & Associates / The Center for Skin Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
RT001 (Botulinum Toxin Type A Topical Gel)
Drug: RT001 (Botulinum Toxin Type A Topical Gel)
Two sequential doses of RT001 at Baseline (Day 0) and Week 2
Placebo Comparator: 2
Vehicle Control
Other: Vehicle Control
Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
Time Frame: Baseline (Day 0) and Week 6
Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Time Frame: Baseline (Day 0) and Week 6
Baseline (Day 0) and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revance Therapeutics, Inc.

Investigators

  • Principal Investigator: Suzanne Bruce, MD, The Center for Skin Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 17, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (Estimate)

April 20, 2009

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT001-CL011LCL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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