Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines

Skin Aging Clinical Trial

— REALISE 1  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580370
• Other study ID #: RT001-CL038
• 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

• Skin Aging

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