Subject Satisfaction With AbobutulinumtoxinA Treatment

Phase 4

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: AbobotulinumtoxinA

• Registration Number: NCT03687736
• Lead Sponsor: Galderma R&D

Brief Summary

An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.

Detailed Description

Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.

Study Timeline

• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Study Start: 2018-10-02
• Primary Completion: 2019-11-07
• Study Completion: 2019-12-04
• Results First Submitted: 2020-02-18
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-03
• Results First Posted: 2020-03-18
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Moderate to Severe Glabellar Lines at Maximum Frown
• Understands study requirements and signs an informed consent

Exclusion Criteria

• Known allergy to any component of study product
• Pregnant or breast feeding or intending to get pregnant during the study
• Botulinum toxin treatment in the face within 9 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AbobotulinumtoxinA	AbobotulinumtoxinA	Open-label

Primary Outcome Measures

Name	Time	Method
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines	12 months	Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.

Secondary Outcome Measures

Name	Time	Method
Evaluate the Impact of Treatment; Psychological Function	Months 1,3,6,7,9 and 12	FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Subject Self-Assessment Using a 4-point Categorical Scale	Months 1,3,6,7,9 and 12	Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity	Months 1,3,6,7,9 and 12	Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.
Subject Satisfaction With Aesthetic Outcome in Treated Area	Months 1,3,6,7,9 and 12	based on Subject Satisfaction questionnaire data
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows	Months 1,3,6,7,9 and 12	FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Onset of Treatment Response	After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit	Subject perception of treatment response

Trial Locations

Locations (1)

Galderma Study Site; 🇺🇸 Omaha, Nebraska, United States