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

Phase 2

Completed

• Conditions: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
• Interventions: Drug: Placebo (Dose B); Drug: Botulinum Toxin Type A

• Registration Number: NCT01064518
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.

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 RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Disposition First Submitted: 2011-06-13
• Disposition First Submitted QC: 2011-06-13
• Disposition First Posted: 2011-06-27
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control
• Previous participation in a RT001 clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose B	Placebo (Dose B)	Placebo Comparator
Dose A	Botulinum Toxin Type A	RT001 Topical Gel

Primary Outcome Measures

Name	Time	Method
The number of subjects who show improvement based on the investigator global and patient assessments.	Week 4

Secondary Outcome Measures

Name	Time	Method
The number of subjects who show improvement based on the investigator global and patient assessments.	Week 8

Trial Locations

Locations (1)

Dermatology Research Institute, LLC; 🇺🇸 Coral Gables, Florida, United States