Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines

Glabellar Rhytides Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814670
• Other study ID #: AP-BTXC-12-001
• Status: Completed
• Phase: Phase 4
• Start date: March 6, 2013
• Est. completion date: October 29, 2014

Study information

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

Clinical Trial Summary

A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 29, 2014
• Est. primary completion date: July 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• moderate or severe frown lines

• facial laser treatment between 4 to 8 weeks prior to Day 1

Exclusion Criteria:

• previous use of botulinum toxin for any indication

• diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

• microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months

• facial cosmetic procedures within the last 6 Months

• treatment to forehead, brow, nose or midface areas with any filler within the last 12 months

• use of a new topical skin care product within 1 month of the screening

• any prior forehead or periorbital surgery or brow lift

• deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity

• any facial skin infection or unhealed skin lesion

• pregnant or breast-feeding

Related Conditions & MeSH terms

• Glabellar Rhytides

Intervention

Biological:
• botulinum toxin Type A
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

China, 

References & Publications (1)

Wu Y, Lu Z, Xie Y, Zhang W, Chen X, Shi Y, Li Q, Halstead M, Rogers JD, Silberberg M. OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study. J Cosmet Laser Ther. 2018 Oct;20(5):278-286. doi: 10.1080/14764172.2017.1406604. Epub 2018 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With a = 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a = 1-grade improvement from Day 1 is reported.	Day 1, Day 30
Secondary	Percentage of Subjects With a = 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a = 1-grade improvement from Day 1 is reported.	Day 1, Day 14, Day 90, Day 120
Secondary	Percentage of Subjects With a = 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a = 1-grade improvement from Day 1 is reported.	Day 1, Day 14, Day 30, Day 90, Day 120
Secondary	Percentage of Subjects With a = 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest	The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a = 1-grade improvement from Day 1 is reported.	Day 1, Day 14, Day 30, Day 90, Day 120
Secondary	Percentage of Subjects With a = 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest	The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a = 1-grade improvement from Day 1 is reported.	Day 1, Day 14, Day 30, Day 90, Day 120