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

COMPLETEDPHASE2

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

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

NCT03911102•Revance Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Sacramento, CA Site

Sacramento, California, United States

Sarasota, FL Site

Sarasota, Florida, United States

Itasca, IL Site

Itasca, Illinois, United States

Arlington, VA Site

Arlington, Virginia, United States

Key Dates

Start Date

March 11, 2019

Primary Completion Date

April 23, 2020

Completion Date

April 23, 2020

Last Updated

June 27, 2023

Enrollment

ACTUAL participants

Conditions

Lateral Canthal Lines

Interventions

DaxibotulinumtoxinA for injection

BIOLOGICAL

ET-01 in Subjects With Lateral Canthal Lines, LCL-210

NCT04985916

Lateral Canthal Lines, LCLCrow's Feet

View study

COMPLETEDPHASE3

Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

NCT04225260

Glabellar LinesLateral Canthal Lines

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ET-01 in Subjects With Lateral Canthal Lines, LCL-210

Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults