- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01797094
BOTOX® in the Treatment of Upper Facial Lines in Japan
January 27, 2015 updated by: Allergan
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-Moderate to severe Crow's Feet Lines and Frown Lines
Exclusion Criteria:
- Current or previous botulinum toxin treatment of any serotype
- Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
- Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
- Medium-depth or deep facial peels within 5 years
- Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Botulinum toxin Type A (44U)
44 units (U) botulinum toxin Type A (total dose) per treatment.
24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1.
Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
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44 units botulinum toxin Type A (total dose) per treatment.
24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
Other Names:
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EXPERIMENTAL: Botulinum toxin Type A (32U)
32 units (U) botulinum toxin Type A (total dose) per treatment.
12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1.
Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
|
32 units botulinum toxin Type A (total dose) per treatment.
12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
Time Frame: Day 30
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The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe.
The percentage of participants with a score of none or mild at Day 30 is reported.
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Day 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL)
Time Frame: Day 30
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Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30.
The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.
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Day 30
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Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
Time Frame: Baseline, Day 30
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The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days.
Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : "When I look in the mirror, my facial lines make me look older than I want to look" score.
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Baseline, Day 30
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Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
Time Frame: Baseline, Day 30
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The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days.
Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much).
FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: "My facial lines make me look less attractive than I want to look" score.
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Baseline, Day 30
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Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
Time Frame: Baseline, Day 30
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The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days.
Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: "My facial lines make me look tired" score.
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Baseline, Day 30
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Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
Time Frame: Baseline, Day 30
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Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30.
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Baseline, Day 30
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Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire
Time Frame: Day 30
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Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied.
The percentage of participants mostly or very satisfied is reported.
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Day 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
February 20, 2013
First Submitted That Met QC Criteria
February 20, 2013
First Posted (ESTIMATE)
February 22, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
February 10, 2015
Last Update Submitted That Met QC Criteria
January 27, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Facies
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 191622-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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