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

Glabellar Frown Lines Clinical Trial

Official title:

A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391299
• Other study ID #: GMA-BTXC-10-002
• Status: Completed
• Phase: N/A
• Start date: June 1, 2011
• Est. completion date: February 28, 2012

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 28, 2012
• Est. primary completion date: October 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Facial Rhytides
• Glabellar Frown Lines

Intervention

Biological:
• botulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.

Drug:
• Normal Saline
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Solish N, Rivers JK, Humphrey S, Muhn C, Somogyi C, Lei X, Bhogal M, Caulkins C. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial. Dermatol Surg. 2016 Mar;42(3):410-9. doi: 10.1097/DSS.0000000000000626. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Day 30
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	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.	Day 30
Secondary	Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines	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.	Day 30
Secondary	Percentage of Participants With a =1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest	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.	Baseline, Day 30
Secondary	Percentage of Participants With a =1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest	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.	Baseline, Day 30