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
1 other identifier
interventional
120
1 country
6
Brief Summary
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 27, 2018
CompletedStudy Start
First participant enrolled
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2019
CompletedResults Posted
Study results publicly available
March 18, 2020
CompletedAugust 26, 2022
March 1, 2020
1.1 years
September 19, 2018
February 18, 2020
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Subject Satisfaction With Aesthetic Outcome in Treated Area
Months 1,3,6,7,9 and 12
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
Months 1,3,6,7,9 and 12
Evaluate the Impact of Treatment; Psychological Function
Months 1,3,6,7,9 and 12
Subject Self-Assessment Using a 4-point Categorical Scale
Months 1,3,6,7,9 and 12
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity
Months 1,3,6,7,9 and 12
- +1 more secondary outcomes
Study Arms (1)
AbobotulinumtoxinA
OTHEROpen-label
Interventions
AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Eligibility Criteria
You may qualify if:
- Moderate to Severe Glabellar Lines at Maximum Frown
- Understands study requirements and signs an informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (6)
Galderma Study Site
Los Angeles, California, 90025, United States
Galderma Study Site
San Francisco, California, 94115, United States
Galderma Study Site
Santa Monica, California, 90404, United States
Galderma Study Site
Greenwood Village, Colorado, 80111, United States
Galderma Study Site
Chicago, Illinois, 60654, United States
Galderma Study Site
Omaha, Nebraska, 68144, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Q-Med AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 27, 2018
Study Start
October 2, 2018
Primary Completion
November 7, 2019
Study Completion
December 4, 2019
Last Updated
August 26, 2022
Results First Posted
March 18, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share