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

NCT01776606 | Completed Phase 3

• 1 other identifier: RT001-CL019
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

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

  Week 4

Secondary Outcomes (3)

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

  Week 4

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

  Week 4

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

  Week 4

Study Arms (2)

Dose A

ACTIVE COMPARATOR

Dose A: Botulinum toxin type A

Drug: Botulinum Toxin Type A

Dose B

PLACEBO COMPARATOR

Dose B: Placebo

Drug: Placebo

Interventions

Botulinum Toxin Type A DRUG

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

Dose A

Placebo DRUG

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

Dose B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 28, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 7, 2014

Record last verified: 2014-04

Locations

US (1)