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CompletedNCT00907387Updated Jan 17, 2014

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

A Phase 2 interventional study of RT001 and RT001 in Lateral Canthal Lines, sponsored by Revance Therapeutics, Inc.. Completed at 9 sites in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-17.

Sponsored by Revance Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.

At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.

02

Conditions studied

  • Lateral Canthal Lines

Keywords

  • Lateral Canthal Lines
  • Crow's Feet
  • Facial Wrinkles
03

In context

Lead sponsor

Revance Therapeutics, Inc. is the lead sponsor of 29 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female or male, 30 to 60 years of age
  • Bilateral lateral canthal lines rated as moderate or severe
  • Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and 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

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
  • 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.
  • Previous treatment with Botulinum Toxin Type A in the face area
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Dose A

    Dose A RT001

    Drug: RT001

  • Active comparator
    Dose B

    Dose B RT001

    Drug: RT001

  • Placebo comparator
    Dose C

    Dose C Placebo

    Other: Placebo

Interventions

  • DrugRT001

    Dose A RT001

  • DrugRT001

    Dose B RT001

  • OtherPlacebo

    Dose C Placebo

06

What researchers measure

Primary outcomes

  1. The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28

    Time frame: Day 28

Secondary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: Day 28

07

Study locations

9 sites
  • Total Skin & Beauty Dermatology Center
    Birmingham, Alabama 35205, United States
  • Richard G. Glogau, Inc.
    San Francisco, California 94117, United States
  • Dermatology Research Institute, LLC
    Coral Gables, Florida 33146, United States
  • SkinCare Physicians, Inc.
    Chestnut Hill, Massachusetts 02467, United States
  • Skin Specialists, PC
    Omaha, Nebraska 68144, United States
  • Head and Neck Surgical Group
    New York City, New York 10019, United States
  • Aesthetic Plastic Surgery
    New York City, New York 10065, United States
  • Dermatology Surgery and Laser Center
    White Plains, New York 10604, United States
  • Suzanne Bruce & Associates / The Center for Skin Research
    Houston, Texas 77056, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00907387
Lead sponsor
Revance Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 22, 2009
Start date
Apr 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Jan 17, 2014

Study contacts

Debbie Tranowski
study director · Revance Therapeutics, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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