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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental | 142 | |
| Placebo | 0 |
Last reviewed · How we verify
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Phase 3 trial testing AbobotulinumtoxinA in Glabellar Frown Lines in 301 participants. Completed in 16 April 2020.
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 301 |
| Start date | 17 June 2019 |
| Primary completion | 27 September 2019 |
| Estimated completion | 16 April 2020 |
| Sites | 11 locations across United States |
Galderma R&D — full company profile →
Adults 18 to 65, any sex, with Glabellar Frown Lines. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental | 142 | |
| Placebo | 0 |
Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Experimental | Placebo |
|---|---|---|---|
| Worsening knee pain | Musculoskeletal and connective tissue disorders | — | — |
| Acute diverticulitis | Infections and infestations | — | — |
| Long QT syndrome | Cardiac disorders | — | — |
| Worsening of hemorrhoids | Gastrointestinal disorders | — | — |
| Reaction | System | Experimental | Placebo |
|---|---|---|---|
| Headache | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Eyelid ptosis | Eye disorders | — | — |
| injection site pain | General disorders | — | — |
| Migraine | Nervous system disorders | — | — |
| Injection site reaction | General disorders | — | — |
| Injection site discomfort | General disorders | — | — |
| sinus pain | Respiratory, 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.
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines
1 peer-reviewed publication reference this trial (live from Europe PMC):
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