Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

Not Applicable

Completed

• Conditions: Facial Rhytides; Glabellar Frown Lines
• Interventions: Biological: botulinum toxin Type A; Drug: Normal Saline

• Registration Number: NCT01391299
• Lead Sponsor: Allergan

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2011-10-18
• Study Completion: 2012-02-28
• Results First Submitted: 2012-10-26
• Results First Submitted QC: 2012-10-26
• Results First Posted: 2012-11-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A (40 Units)	botulinum toxin Type A	Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
botulinum toxin Type A (30 Units)	botulinum toxin Type A	Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
placebo (Normal saline)	Normal Saline	Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.

Primary Outcome Measures

Name	Time	Method
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	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.
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	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest	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.
Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines	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.
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest	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.