AbobotulinumtoxinA
BiologicalAbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Completed
NCT Number: NCT03687736
Subject Satisfaction With AbobutulinumtoxinA Treatment
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Galderma Study Site, Los Angeles, California, United States
Loading trial locations.
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
Time frame: 12 months
Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.
Secondary outcomes
-
Subject Satisfaction With Aesthetic Outcome in Treated Area
Time frame: Months 1,3,6,7,9 and 12
based on Subject Satisfaction questionnaire data
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Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
Time frame: 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.
-
Evaluate the Impact of Treatment; Psychological Function
Time frame: 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
Time frame: 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
Time frame: 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.
-
Onset of Treatment Response
Time frame: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit
Subject perception of treatment response
Sponsors and collaborators
Lead sponsor
Galderma R&D
Industry
Registry information
Official study title
A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines
Acronym: DREAM
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Sep 27, 2018
- Registry last updated
- Aug 26, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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