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

• Sponsor: Revance Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03911102
• Collaborator: (none)
• Enrollment: 63
• Locations: 4
• Arms: 4
• Actual Duration (Months): 13.4
• Patients Per Site: 15.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lateral Canthal Lines	Biological: DaxibotulinumtoxinA for injection	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 11, 2019
• Actual Primary Completion Date: Apr 23, 2020
• Actual Study Completion Date: Apr 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: DaxibotulinumtoxinA Dose A Subjects will receive Dose A of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 2: DaxibotulinumtoxinA Dose B Subjects will receive Dose B of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 3: DaxibotulinumtoxinA Dose C Subjects will receive Dose C of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 4: DaxibotulinumtoxinA Dose D Subjects will receive Dose D of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection

Outcome Measures

Primary Outcome Measures

1. The incidence, severity, and relationship to study drug of treatment-emergent Adverse Events (AEs) (TEAEs) and serious adverse events (SAEs) [Baseline-Week 36]

   Number of participants with TEAEs and SAEs will be evaluated (safety and tolerability)

2. Proportion of subjects achieving a score of 0 or 1 (none or mild) in Lateral Canthal Lines (LCL) severity on the Investigator Global Assessment Lateral Canthal Wrinkle Severity scale [Baseline-Week 36]

   Evaluate the efficacy of DAXI for injection using the proportion of subjects achieving a score of 0 or 1 (none or mild) in LCL severity on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale

Secondary Outcome Measures

1. The responder rate of DAXI for injection in the treatment of Lateral Canthal Lines (LCL) [Baseline-Week 36]

   The responder rate is determined by the proportion of subjects achieving a score of 0 or 1 (none or mild) in Lateral Canthal Lines (LCL) severity at maximum smile on the Patient Lateral Canthal Wrinkle Severity (PLCWS) scale at 4 weeks after Lateral Canthal Lines (LCL) treatment

2. The responder rate of DAXI for injection in the treatment of Lateral Canthal Lines (LCL) [Baseline-Week 36]

   The responder rate is determined by the proportion of subjects achieving an improvement of at least 1 point from baseline in LCL severity at maximum smile on the IGA-LCWS at Week 4 after LCL treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sacramento, CA Site	Sacramento	California	United States	95816
2	Sarasota, FL Site	Sarasota	Florida	United States	34239
3	Itasca, IL Site	Itasca	Illinois	United States	60143
4	Arlington, VA Site	Arlington	Virginia	United States	22209

Sponsors and Collaborators

• Revance Therapeutics, Inc.

Investigators

• Study Director: Dom Vitarella, Revance Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Revance Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03911102
• Other Study ID Numbers: 1820205
• First Posted: Apr 10, 2019
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Revance Therapeutics, Inc.: Lateral canthal wrinkle; Crow's feet lines; LCL
• Additional relevant MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Feb 18, 2021