Subject Satisfaction With AbobutulinumtoxinA Treatment

Glabellar Frown Lines Clinical Trial

— DREAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687736
• Other study ID #: 43USD1802
• Status: Completed
• Phase: Phase 4
• Start date: October 2, 2018
• Est. completion date: December 4, 2019

Study information

• Verified date: March 2020
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 4, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• AbobotulinumtoxinA
AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6

Locations

Country	Name	City	State
United States	Galderma Study Site	Chicago	Illinois
United States	Galderma Study Site	Greenwood Village	Colorado
United States	Galderma Study Site	Los Angeles	California
United States	Galderma Study Site	Omaha	Nebraska
United States	Galderma Study Site	San Francisco	California
United States	Galderma Study Site	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subject Satisfaction With Aesthetic Outcome in Treated Area	based on Subject Satisfaction questionnaire data	Months 1,3,6,7,9 and 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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