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

Skin Aging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940991
• Other study ID #: RT001-CL035
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2013
• Last updated: December 27, 2013
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Aging

Intervention

Drug:
• Placebo
Placebo, Dose B; dose applied to the lateral canthal lines
• Botulinum Toxin Type A
Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines

Locations

Country	Name	City	State
United States	Dermatology Research Institute	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint	Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines	Week 4	No
Secondary	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	Week 4	No
Secondary	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	Week 4	No
Secondary	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	Week 4	No