Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Revance Therapeutics

Status and phase

Completed

Phase 2

Conditions

Lateral Canthal Lines

Facial Wrinkles

Crow's Feet

Treatments

Drug: RT001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01124565

RT001-CL025LCL

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)