Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 719 for:    Botulinum Toxins, Type A

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01814670
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : September 1, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glabellar Rhytides
Intervention Biological: botulinum toxin Type A
Enrollment 185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Period Title: Overall Study
Started 185
Completed 173
Not Completed 12
Reason Not Completed
Protocol Violation             12
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Number of Baseline Participants 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants
44.8  (8.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants
Female
180
  97.3%
Male
5
   2.7%
1.Primary Outcome
Title Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
Hide Description 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.
Time Frame Day 1, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Percentage of Subjects
97.1
2.Secondary Outcome
Title Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
Hide Description 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.
Time Frame Day 1, Day 14, Day 90, Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Percentage of Subjects
Day 14 97.1
Day 90 90.2
Day 120 81.5
3.Secondary Outcome
Title Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
Hide Description 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.
Time Frame Day 1, Day 14, Day 30, Day 90, Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Percentage of Subjects
Day 14 90.1
Day 30 93.1
Day 90 81.5
Day 120 72.3
4.Secondary Outcome
Title Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
Hide Description 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.
Time Frame Day 1, Day 14, Day 30, Day 90, Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Percentage of Subjects
Day 14 62.7
Day 30 65.7
Day 90 65.7
Day 120 62.7
5.Secondary Outcome
Title Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
Hide Description 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.
Time Frame Day 1, Day 14, Day 30, Day 90, Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Percentage of Subjects
Day 14 59.9
Day 30 58.4
Day 90 50.9
Day 120 49.1
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
 
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
All-Cause Mortality
Botulinum Toxin Type A
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin Type A
Affected / at Risk (%)
Total   0/185 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botulinum Toxin Type A
Affected / at Risk (%)
Total   0/185 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814670     History of Changes
Other Study ID Numbers: AP-BTXC-12-001
First Submitted: March 18, 2013
First Posted: March 20, 2013
Results First Submitted: August 5, 2015
Results First Posted: September 1, 2015
Last Update Posted: April 17, 2019