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

Phase 4

Completed

• Conditions: Glabellar Rhytides
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT01814670
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-06
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Primary Completion: 2014-07-31
• Study Completion: 2014-10-29
• Results First Submitted: 2015-08-05
• Results First Submitted QC: 2015-08-05
• Results First Posted: 2015-09-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• moderate or severe frown lines
• facial laser treatment between 4 to 8 weeks prior to Day 1

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A	botulinum toxin Type A	20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	Day 1, Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	Day 1, Day 14, Day 90, Day 120	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.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction	Day 1, Day 14, Day 30, Day 90, Day 120	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.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest	Day 1, Day 14, Day 30, Day 90, Day 120	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.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest	Day 1, Day 14, Day 30, Day 90, Day 120	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.