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CompletedNCT00968942Updated Nov 19, 2013

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

A Phase 2 interventional study of Botulinum Toxin Type A and Placebo in Lateral Canthal Lines, Crow's Feet and Facial Wrinkles, sponsored by Revance Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-19.

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

Phase
Phase 2
Study type
Interventional
Enrollment
36
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 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

Read the detailed description

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

02

Conditions studied

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

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:

  • 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
  • Muscle weakness or paralysis in the area receiving study treatment
  • Active skin disease or irritation at the treatment areas
  • Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
  • Use of prescription retinoid products during the past 3 months prior to Screening
  • Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
  • Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow lift or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
  • Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
  • Previous treatment with Botulinum Toxin Type A in the face area
  • Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
  • Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at 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
  • Clinically significant laboratory values at Screening
05

Study design

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

Study arms

  • Active comparator
    Dose A

    RT001

    Drug: Botulinum Toxin Type A

  • Placebo comparator
    Dose B

    Placebo

    Drug: Placebo

Interventions

  • DrugBotulinum Toxin Type A

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

  • DrugPlacebo

    Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

06

What researchers measure

Primary outcomes

  1. The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs

    Time frame: Week 8

Secondary outcomes

  1. The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Smile and at Rest from Baseline to Weeks 2, 4, 6, 8; incidence of treatment emergent AEs

    Time frame: Weeks 2, 4, 6, 8

07

Study locations

1 site
  • Dermatology Research Institute, LLC.
    Coral Gables, Florida 33146, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00968942
Lead sponsor
Revance Therapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 31, 2009
Start date
Aug 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Nov 19, 2013

Study contacts

Frederic S Brandt, M.D.
principal investigator · Dermatology Research Institute, LLC.

Oversight

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

Not currently enrolling

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

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