Safety Study of Two Repeat Doses 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: RT001

• Registration Number: NCT01124565
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Detailed Description

Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-17
• 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: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 child bearing potential (WOCBP) but is not willing to use an effective method of birth control
• Previous participation in a RT001 clinical study
• Previous treatment with botulinum toxin (any serotype)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RT001	RT001	RT001 (Botulinum Toxin Type A) Topical Gel

Primary Outcome Measures

Name	Time	Method
Assessment of treatment-emergent adverse events based on safety assessments.	4 weeks and 8 weeks

Trial Locations

Locations (3)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Total Skin & Beauty Dermatology Center, PC; 🇺🇸 Birmingham, Alabama, United States

Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States