Subject Satisfaction With AbobutulinumtoxinA Treatment (DREAM)

A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines

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

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: AbobotulinumtoxinA

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Galderma Study Site
    • San Francisco, California, United States, 94115
      • Galderma Study Site
    • Santa Monica, California, United States, 90404
      • Galderma Study Site
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Galderma Study Site
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Galderma Study Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Galderma Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: AbobotulinumtoxinA; Open-label	Biological: AbobotulinumtoxinA; AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction With Aesthetic Outcome in Treated Area	based on Subject Satisfaction questionnaire data	Months 1,3,6,7,9 and 12
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows	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.	Months 1,3,6,7,9 and 12
Evaluate the Impact of Treatment; Psychological Function	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.	Months 1,3,6,7,9 and 12
Subject Self-Assessment Using a 4-point Categorical Scale	Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown	Months 1,3,6,7,9 and 12
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity	Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.	Months 1,3,6,7,9 and 12
Onset of Treatment Response	Subject perception of treatment response	After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2018
• Primary Completion (ACTUAL): November 7, 2019
• Study Completion (ACTUAL): December 4, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (ACTUAL): September 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 43USD1802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No