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

Revance Therapeutics, Inc.27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glabellar Frown Lines

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be outpatient, male or female subjects, in good general health, 18 years of age or older 2. Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS 3. Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS Exclusion Criteria: 1. 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 2. Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception 3. Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product

Outcomes

Primary Outcomes

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

Time frame: 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