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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02580370
Other study ID # RT001-CL038
Secondary ID
Status Completed
Phase Phase 3
First received October 15, 2015
Last updated September 7, 2016
Start date September 2015
Est. completion date August 2016

Study information

Verified date September 2016
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 is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- In good general health

- Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment

- Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

Exclusion Criteria:

- Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis

- Muscle weakness or paralysis, particularly in the area receiving study treatment

- Active skin disease or irritation or disrupted barrier at the treatment area

- Active eye disease or irritation

- Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart

- Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening

- Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening

- Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else 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

Biological:
Botulinum toxin type A
Topical botulinum toxin type A
Placebo comparator
Topical placebo comparator

Locations

Country Name City State
n/a

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 based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines Week 4 No
Secondary Investigator Global Assessment with 2 points or greater improvement from baseline Proportion of subjects with 2 points 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
Secondary Patient Severity Assessment with 1 points or greater improvement from baseline Proportion of subjects with a 1 point or greater improvement from baseline using the Patient Severity Assessment Week 4 No
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