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A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

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ClinicalTrials.gov Identifier: NCT01124552
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Crow's Feet Facial Wrinkles Drug: RT001 Botulinum toxin type A (Dose A) Drug: RT001 Botulinum Toxin Type A (Dose B) Other: Vehicle Drug: Placebo Phase 2

Detailed Description:
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Study Start Date : April 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: RT001 Botulinum toxin Type A (Dose A)
RT001 (Botulinum toxin Type A)
Drug: RT001 Botulinum toxin type A (Dose A)
RT001 Botulinum Toxin Type A (Dose A)
Experimental: RT001 Botulinum toxin type A (Dose B)
RT001 (Botulinum Toxin Type A)
Drug: RT001 Botulinum Toxin Type A (Dose B)
RT001 Botulinum Toxin Type A (Dose B)
Dose C
Vehicle Control
Other: Vehicle
Vehicle Control
Placebo Comparator: Dose D
Placebo
Drug: Placebo
Placebo Comparator


Outcome Measures

Primary Outcome Measures :
  1. Subject improvement based in investigator assessment [ Time Frame: Week 4 ]
    The number of subjects who show improvement based on the investigator global assessment


Secondary Outcome Measures :
  1. Subject Improvement Based on investigator and patient assessments [ Time Frame: Week 4 ]
    The number of subjects who show improvement based on the investigator global and patient assessments


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent including authorization to release health information
  • Female or male, 18 to 65 years of age and in good general health
  • Willing and able to follow study instructions and likely to complete all study requirements
  • Moderate to severe lateral canthal lines (crow's feet wrinkles)

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 such as Lambert-Eaton syndrome and myasthenia gravis
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active disease or irritation at the treatment areas including the eye and the skin
  • Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
  • Previous participation in a RT001 clinical study
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01124552


Locations
United States, Florida
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
Revance Therapeutics, Inc.
More Information

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01124552     History of Changes
Other Study ID Numbers: RT001-CL017LCL
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: December 2013

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

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
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