Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines

NCT06411002 | Completed Phase 2 FDA Drug

• 1 other identifier: 2320201
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL). Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent. The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (2)

• IGA-FWS

  • The proportion 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

• IGA-FHWS

  • The proportion 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

Study Arms (1)

Active Treatment (DAXXIFY)

EXPERIMENTAL

All subjects will receive DAXXIFY for injection as IM injections.

Drug: DAXXIFY

Interventions

DAXXIFY DRUG

Intramuscular injection of daxibotulintoxinA-lanm

Also known as: DAXI

Active Treatment (DAXXIFY)

Eligibility Criteria

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

You may qualify if:

• 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) GL during maximum contraction as assessed by the IGA-FWS
• Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS

You may not qualify if:

• Previous treatment with botulinum toxin type A in the face, or treatment with \>200 U of any botulinum toxin anywhere else in the body, in the past 6 months prior to screening
• Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception
• Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Revance

Nashville, Tennessee, 37203, United States

Location

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: May 8, 2024
• First Posted: May 13, 2024
• Study Start: April 8, 2024
• Primary Completion: December 12, 2024
• Study Completion: February 12, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-02

Locations

US (1)