Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines

NCT04259086 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1920201
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)

Conditions

Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)

Keywords

Lateral Canthal Wrinkle; crow's feet lines; LCL; Forehead Lines; Glabellar Lines; Frown Lines; Upper facial lines

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With None or Mild in GL Severity at Maximum Frown

  The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS

  Week 4

• Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation

  The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS

  Week 4

• Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort

  The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS

  Week 4

Study Arms (1)

DAXI 40 U GL / 32 U FHL / 48 U LCL

EXPERIMENTAL

DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL)

Drug: DaxibotulinumtoxinA for injection

Interventions

DaxibotulinumtoxinA for injection DRUG

Intramuscular injection

DAXI 40 U GL / 32 U FHL / 48 U LCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-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 years of age or older
• Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS)
• Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS)
• Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately)
• Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study

You may not qualify if:

• Active skin disease, infections, or inflammation at the injection sites
• 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 a 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (8)

Site 1

Manhattan Beach, California, 90266, United States

Location

Site 3

San Diego, California, 92121, United States

Location

Site 7

Santa Monica, California, 90404, United States

Location

Site 5

Coral Gables, Florida, 33146, United States

Location

Site 2

Chestnut Hill, Massachusetts, 02467, United States

Location

Site 6

New York, New York, 10028, United States

Location

Site 4

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Site 8

Toronto, Ontario, M5R3N8, Canada

Location

Related Publications (1)

• Dover JS, Humphrey SD, Lorenc ZP, Shamban A, Gross TM, Rubio RG, Vitarella D. Treatment of Upper Facial Lines With DaxibotulinumtoxinA for Injection: Results From an Open-Label Phase 2 Study. Dermatol Surg. 2023 Jan 1;49(1):60-65. doi: 10.1097/DSS.0000000000003637. Epub 2022 Nov 28.

  PMID: 36533798 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A; Injections

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: February 6, 2020
• Study Start: December 6, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Locations

US (6); CA (2)