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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01818076
Other study ID # RT001-CL023
Secondary ID
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


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
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