Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Phase 2CompletedNCT01940991

Revance Therapeutics, Inc.82 enrolled

Overview

This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Skin Aging

Interventions

PlaceboDRUG

Placebo, Dose B; dose applied to the lateral canthal lines

Botulinum Toxin Type ADRUG

Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe crow's feet lines * Female or male, 18 to 65 years of age and in good general health * Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study Exclusion Criteria: * Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A * Muscle weakness or paralysis, particularly in the area receiving study treatment * Active skin disease or irritation at the treatment area * Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart * Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body

Locations (1)

Dermatology Research Institute

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Composite endpoint

Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines

Time frame: Week 4

Secondary Outcomes

Investigator Global Assessment with 2 points or greater improvement from baseline

Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment

Time frame: Week 4

Investigator Global Assessment with 1 point or greater improvement from baseline

Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment

Time frame: Week 4

Patient Severity Assessment with 2 points or greater improvement from baseline

Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment

Time frame: Week 4

Data from ClinicalTrials.gov

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