Glabellar Frown Lines Clinical Trial
Official title:
A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2025 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Revance | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Revance Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
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