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NCT03960957

Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Completed Phase 3 Results posted Last updated 26 August 2022
What this trial tests

Phase 3 trial testing AbobotulinumtoxinA in Glabellar Frown Lines in 301 participants. Completed in 16 April 2020.

Timeline
17 June 2019
Primary endpoint
27 September 2019
16 April 2020

Quick facts

Lead sponsorGalderma R&D
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment301
Start date17 June 2019
Primary completion27 September 2019
Estimated completion16 April 2020
Sites11 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 18 to 65, any sex, with Glabellar Frown Lines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo Primary · Month 1 after treatment

Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)

GroupValue95% CI
Experimental142
Placebo0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental
Serious: 4/223 (2%)
Deaths: 0/223
Placebo
Serious: 0/77 (0%)
Deaths: 0/77

Serious adverse events (4 terms)

ReactionSystemExperimentalPlacebo
Worsening knee painMusculoskeletal and connective tissue disorders
Acute diverticulitisInfections and infestations
Long QT syndromeCardiac disorders
Worsening of hemorrhoidsGastrointestinal disorders
Other adverse events (7 terms — click to expand)

ReactionSystemExperimentalPlacebo
HeadacheNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid ptosisEye disorders
injection site painGeneral disorders
MigraineNervous system disorders
Injection site reactionGeneral disorders
Injection site discomfortGeneral disorders
sinus painRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Worsening knee pain, Acute diverticulitis, Long QT syndrome, Worsening of hemorrhoids.

Data from ClinicalTrials.gov NCT03960957 adverse events section.

Sponsor's own description

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Selected Poster Abstracts from MauiDerm 2022 for Dermatologists.
    · 2022 · PMID 38406582

Verify or expand the search:

Other trials of AbobotulinumtoxinA

Trials testing the same drug.

Other Galderma R&D trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03960957.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing