NCT03911102

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 27, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

March 27, 2019

Results QC Date

June 2, 2023

Last Update Submit

June 2, 2023

Conditions

Lateral Canthal Lines

Keywords

Lateral canthal wrinkleCrow's feet linesLCL

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Cohort 1: DAXI 12 U

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Cohort 2: DAXI 24 U

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Cohort 3: DAXI 36 U

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Cohort 4: DAXI 48 U

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Interventions

DaxibotulinumtoxinA for injectionBIOLOGICAL

Intramuscular injection

Cohort 1: DAXI 12 UCohort 2: DAXI 24 UCohort 3: DAXI 36 UCohort 4: DAXI 48 U

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sacramento, CA Site

Sacramento, California, 95816, United States

Location

Sarasota, FL Site

Sarasota, Florida, 34239, United States

Location

Itasca, IL Site

Itasca, Illinois, 60143, United States

Location

Arlington, VA Site

Arlington, Virginia, 22209, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type AInjections

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Todd Gross, PhD, VP, Clinical Development & Data Science
Organization
Revance Therapeutics, Inc.
tgross@revance.com
510-742-3400

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 10, 2019

Study Start

March 11, 2019

Primary Completion

April 23, 2020

Study Completion

April 23, 2020

Last Updated

June 27, 2023

Results First Posted

June 27, 2023

Record last verified: 2023-06

Locations

US(4)