19 and older, any sex, with Facial Rhytides or 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.
Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow ElevationPrimary· Day 30
The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.
Group
Value
95% CI
Botulinum Toxin Type A (40 Units)
89.5
Botulinum Toxin Type A (30 Units)
85.0
Placebo (Normal Saline)
3.4
Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow ElevationPrimary· Day 30
The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.
Group
Value
95% CI
Botulinum Toxin Type A (40 Units)
87.7
Botulinum Toxin Type A (30 Units)
80.0
Placebo (Normal Saline)
6.9
Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead LinesSecondary· Day 30
Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.
Group
Value
95% CI
Botulinum Toxin Type A (40 Units)
94.4
Botulinum Toxin Type A (30 Units)
81.0
Placebo (Normal Saline)
1.8
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at RestSecondary· Baseline, Day 30
The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.
Group
Value
95% CI
Botulinum Toxin Type A (40 Units)
91.1
Botulinum Toxin Type A (30 Units)
83.3
Placebo (Normal Saline)
15.5
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at RestSecondary· Baseline, Day 30
Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.
Group
Value
95% CI
Botulinum Toxin Type A (40 Units)
89.5
Botulinum Toxin Type A (30 Units)
88.3
Placebo (Normal Saline)
17.2
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 17 April 2019
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/NCT01391299.