Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines - Full Text View

Purpose

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.

Condition	Intervention	Phase
Lateral Canthal Lines	Drug: RT001 Other: Placebo	Phase 2 Phase 3

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, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment Lateral Canthal Lines in Adults

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 at Rest from Baseline (Day 0) to Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of treatment-emergent adverse events [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Enrollment:	72
Study Start Date:	April 2009
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Dose A Dose A RT001	Drug: RT001 Dose A RT001
Active Comparator: Dose B Dose B RT001	Drug: RT001 Dose B RT001
Placebo Comparator: Dose C Dose C Placebo	Other: Placebo Dose C Placebo

Detailed Description:

This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.

At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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:

Muscle weakness or paralysis in the area receiving study treatment -Active skin disease or irritation at the treatment areas
Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to 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 (Day 28)
Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure.
Previous treatment with Botulinum Toxin Type A in the face area

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907387

Locations

United States, Alabama
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
United States, California
Richard G. Glogau, Inc.
San Francisco, California, United States, 94117
United States, Florida
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
United States, Massachusetts
SkinCare Physicians, Inc.
Chestnut Hill, Massachusetts, United States, 02467
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New York
Aesthetic Plastic Surgery
New York City, New York, United States, 10065
Head and Neck Surgical Group
New York City, New York, United States, 10019
Dermatology Surgery and Laser Center
White Plains, New York, United States, 10604
United States, Texas
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, United States, 77056

Sponsors and Collaborators

Revance Therapeutics, Inc.

Investigators

Study Director:

Debbie Tranowski

Revance Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Deborah Tranowski, VP Clinical Operations, Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00907387 History of Changes
Other Study ID Numbers:	RT001-CL010LCL
Study First Received:	May 20, 2009
Last Updated:	September 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Revance Therapeutics, Inc.:

Lateral Canthal Lines
Crow's Feet
Facial Wrinkles

Additional relevant MeSH terms:

Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013