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

Facial Wrinkles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124552
• Other study ID #: RT001-CL017LCL
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2010
• Last updated: December 24, 2013
• Start date: April 2010
• Est. completion date: July 2010

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

• Crow's Feet
• Facial Wrinkles
• Lateral Canthal Lines

Intervention

Drug:
• RT001 Botulinum toxin type A (Dose A)
RT001 Botulinum Toxin Type A (Dose A)
• RT001 Botulinum Toxin Type A (Dose B)
RT001 Botulinum Toxin Type A (Dose B)

Other:
• Vehicle
Vehicle Control

Drug:
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	Dermatology Research Institute, LLC	Coral Gables	Florida

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	Subject improvement based in investigator assessment	The number of subjects who show improvement based on the investigator global assessment	Week 4	No
Secondary	Subject Improvement Based on investigator and patient assessments	The number of subjects who show improvement based on the investigator global and patient assessments	Week 4	No