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

Lateral Canthal Lines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907387
• Other study ID #: RT001-CL010LCL
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2009
• Last updated: December 16, 2013
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2013
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Canthal Lines

Intervention

Drug:
• RT001
Dose A RT001
• RT001
Dose B RT001

Other:
• Placebo
Dose C Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28		Day 28	No
Secondary	Incidence of treatment-emergent adverse events		Day 28	Yes