Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: AbobotulinumtoxinA dose 4; Other: placebo; Biological: AbobotulinumtoxinA dose level 1 or 2; Biological: AbobotulinumtoxinA dose 3

• Registration Number: NCT03736928
• Lead Sponsor: Galderma R&D

Brief Summary

An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2018-11-26
• Primary Completion: 2019-12-09
• Study Completion: 2020-08-20
• Results First Submitted: 2020-12-21
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-20
• Results First Posted: 2021-02-11
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
• Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale

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Exclusion Criteria

• Botulinum toxin treatment in the face within 9 months prior to study treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AbobotulinumtoxinA dose level 4	AbobotulinumtoxinA dose 4	Intramuscular single treatment
Placebo	placebo	Intramuscular single treatment
AbobotulinumtoxinA dose level 1 or 2	AbobotulinumtoxinA dose level 1 or 2	Intramuscular single treatment
AbobotulinumtoxinA dose level 3	AbobotulinumtoxinA dose 3	Intramuscular single treatment

Primary Outcome Measures

Name	Time	Method
Number of Composite Responders at Month 1	Month 1 after treatment	composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)

Trial Locations

Locations (1)

Galderma Research Site; 🇺🇸 Mequon, Wisconsin, United States