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

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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)

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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