Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

Lateral Canthal Lines Clinical Trial

Official title:

A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911102
• Other study ID #: 1820205
• Status: Completed
• Phase: Phase 2
• Start date: March 11, 2019
• Est. completion date: April 23, 2020

Study information

• Verified date: June 2023
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed

• Be outpatient, male or female subjects, in good general health, 18-65 years old

• Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS

• Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

• Active skin disease, infections, or inflammation at the injection sites

• History of clinically significant bleeding disorders

• Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator

• Planned or anticipated need for surgery or hospitalization through the end of the study

• Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception

• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study

Related Conditions & MeSH terms

• Lateral Canthal Lines

Intervention

Biological:
• DaxibotulinumtoxinA for injection
Intramuscular injection

Locations

Country	Name	City	State
United States	Arlington, VA Site	Arlington	Virginia
United States	Itasca, IL Site	Itasca	Illinois
United States	Sacramento, CA Site	Sacramento	California
United States	Sarasota, FL Site	Sarasota	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	Percentage of Participants With None or Mild in LCL Severity at Maximum Smile	Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale	Week 4 After LCL Treatment