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

This study has been completed.
Sponsor:
Information provided by:
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00884234
First received: April 17, 2009
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Lateral Canthal Lines
 Other: Vehicle Control
Drug: RT001 (Botulinum Toxin Type A Topical Gel)
 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, 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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment emergent AEs. [ Time Frame: Baseline (Day 0) and Week 6 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884234

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

No publications provided

Responsible Party: Deborah Tranowski, Vice President, Clinical Operations, Revance Therapeutics
ClinicalTrials.gov Identifier: NCT00884234     History of Changes
Other Study ID Numbers: RT001-CL011LCL
Study First Received: April 17, 2009
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration

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

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 22, 2013