Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Phase 3

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Other: Placebo; Biological: AbobotulinumtoxinA

• Registration Number: NCT03960957
• Lead Sponsor: Galderma R&D

Brief Summary

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Study Start: 2019-06-17
• Primary Completion: 2019-09-27
• Study Completion: 2020-04-16
• Disposition First Submitted: 2020-07-24
• Results First Submitted: 2021-04-13
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-10
• Disposition First Submitted QC: 2021-05-10
• Results First Posted: 2021-05-11
• Disposition First Posted: 2021-05-11
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Moderate to severe glabellar lines at maximum frown
• Understands the study requirements and signs an informed consent form

Exclusion Criteria

• Botulinum toxin treatment in the face within 6 months prior to study treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Experimental	AbobotulinumtoxinA	AbobotulinumtoxinA

Primary Outcome Measures

Name	Time	Method
Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo	Month 1 after treatment	Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)

Trial Locations

Locations (1)

Galderma Study Site; 🇺🇸 Spring, Texas, United States