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

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines

Treatments: Biological: DaxibotulinumtoxinA for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03911102

1820205

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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63 participants in 4 patient groups

Cohort 1: DAXI 12 U

Experimental group

Description:

DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)

Treatment:

Biological: DaxibotulinumtoxinA for injection

Cohort 2: DAXI 24 U

Experimental group

Description:

DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)

Treatment:

Biological: DaxibotulinumtoxinA for injection

Cohort 3: DAXI 36 U

Experimental group

Description:

DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)

Treatment:

Biological: DaxibotulinumtoxinA for injection

Cohort 4: DAXI 48 U

Experimental group

Description:

DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)

Treatment:

Biological: DaxibotulinumtoxinA for injection