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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

This study has been completed.
Sponsor:
Information provided by:
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01124552
First received: May 6, 2010
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
 Drug: RT001
Drug: Botulinum Toxin Type A
Drug: Inactive Ingredients
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Botox Foot Health
U.S. FDA Resources

Further study details as provided by Revance Therapeutics, Inc.:

Primary Outcome Measures:
  • Subject improvement based in investigator assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The number of subjects who show improvement based on the investigator global assessment


Secondary Outcome Measures:
  • Subject Improvement Based on investigator and patient assessments [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The number of subjects who show improvement based on the investigator global and patient assessments


Enrollment: 180
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose A
Active Treatment
 Drug: RT001
Botulinum Toxin Type A Topical Gel (drug product with inactive ingredients)
Other Name: Botulinum Toxin Type A (drug product with inactive ingredients)
Dose B
Comparator
 Drug: Botulinum Toxin Type A
Botulinum Toxin Type A (toxin only no inactive ingredients)
Other Name: Botulinum Toxin Type A (toxin only with no inactive ingredients)
Dose C
Comparator
 Drug: Inactive Ingredients
inactive ingredients; no Botulinum Toxin Type A
Other Name: inactive ingredients
Placebo Comparator: Dose D
Comparator
 Drug: Placebo
Placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 WOCBP but is not willing to use an effective method of birth control
  • Previous participation in a RT001 clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124552

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

No publications provided

Responsible Party: Deborah Tranowski, Vice President, Clinical Operations, Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01124552     History of Changes
Other Study ID Numbers: RT001-CL017LCL
Study First Received: May 6, 2010
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013