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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884234
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Other: Vehicle Control Drug: RT001 (Botulinum Toxin Type A Topical Gel) Phase 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Primary Completion Date : April 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

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 or Vehicle Control at Baseline (Day 0) and Week 2
Placebo Comparator: 2
Vehicle Control
Other: Vehicle Control
Two sequential doses of RT001 or Vehicle Control at Baseline (Day 0) and Week 2

Primary Outcome Measures :
  1. 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 ]
  2. Incidence of treatment emergent AEs. [ Time Frame: Baseline (Day 0) and Week 6 ]

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884234

United States, Texas
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, United States, 77056
Sponsors and Collaborators
Revance Therapeutics, Inc.
Principal Investigator: Suzanne Bruce, MD The Center for Skin Research

Responsible Party: Revance Therapeutics, Inc. Identifier: NCT00884234     History of Changes
Other Study ID Numbers: RT001-CL011LCL
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: October 2013

Keywords provided by Revance Therapeutics, Inc.:
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Lateral Canthal Area

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents