Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Skin Aging Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01818076
• Other study ID #: RT001-CL023
• Status: Terminated
• Phase: Phase 3
• First received: March 20, 2013
• Last updated: April 14, 2014
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• 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 evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 311
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe crow's feet lines

• Female or male, 18 years of age and above and in good general health

• Women of childbearing potential 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 3 months

• Chemical peel during the 9 months prior to treatment

• Use of prescription retinoid products during the 3 months prior to treatment

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Aging

Intervention

Drug:
• Botulinum Toxin Type A
Botulinum toxin type A, Dose A applied to the lateral canthal area

Locations

Country	Name	City	State
United States	Nashville Centre for Laser and Facial Surgery	Nashville	Tennessee

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	Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments		Up to 24 months	Yes
Primary	Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments		Up to 24 months	Yes