Phase 4 N=120 Other

Subject Satisfaction With AbobutulinumtoxinA Treatment

Glabellar Frown Lines

Bottom Line

View on ClinicalTrials.gov: NCT03687736 ↗

Enrolled (actual)

120

Serious AEs

1.7%

Results posted

Mar 2020

Primary outcome: Primary: Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines — 66; 38; 4; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: AbobotulinumtoxinA (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines	66; 38; 4; 2	—
SECONDARY Subject Satisfaction With Aesthetic Outcome in Treated Area	83; 32; 2; 0; 44; 55	—
SECONDARY Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows	31.6; 83.3; 64.2; 44.7; 85.5; 70.7	—
SECONDARY Evaluate the Impact of Treatment; Psychological Function	72.2; 84.0; 81.6; 78.0; 85.1; 82.7	—
SECONDARY Subject Self-Assessment Using a 4-point Categorical Scale	78; 42; 0; 0; 0; 10	—
SECONDARY Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity	82; 38; 0; 0; 0; 2	—
SECONDARY Onset of Treatment Response	2.5; 2.4	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03687736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.