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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01940991
Other study ID # RT001-CL035
Secondary ID
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


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
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