N/A
Completed N=175
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines
Facial Rhytides · Glabellar Frown Lines
Source: ClinicalTrials.gov NCT01391299 ↗
Enrolled (actual)
175
Serious AEs
0.6%
Results posted
Nov 2012
Primary outcomePrimary: 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 Elevation — 89.5; 85.0; 3.4 Percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 Elevation |
89.5; 85.0; 3.4 | — |
| PRIMARY 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 Elevation |
87.7; 80.0; 6.9 | — |
| SECONDARY Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines |
94.4; 81.0; 1.8 | — |
| SECONDARY Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest |
91.1; 83.3; 15.5 | — |
| SECONDARY Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest |
89.5; 88.3; 17.2 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe forehead lines
Exclusion Criteria
- Current or previous botulinum toxin treatment of any serotype within one year
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Oral retinoid therapy within one year
Data sourced from ClinicalTrials.gov (NCT01391299). 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. Informational only — not medical advice.