- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176356
Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
December 19, 2018 updated by: Allergan
A study to evaluate patient satisfaction, aesthetic and psychological impact of combined treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Phase 4
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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California
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Los Angeles, California, United States
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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
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Qualified to receive treatment with BOTOX® Cosmetic, a facial filler (JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA Plus XC and/or JUVÉDERM® VOLUMA® XC) and LATISSE® treatment
- Naïve to botulinum toxin therapy of any serotype for any indication
- Naïve to prescription eyelash growth products of any type
- Naïve to dermal filler treatment in the face and neck
Exclusion Criteria:
- Undergone facial plastic surgery, tissue grafting, tissue augmentation or facial dermal filler injections
- Had laser, photomodulation, intense pulsed light, radio frequency, dermabrasion or chemical peel in the face or neck
- Have received skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 3 months
- Systemic retinoid therapy within 1 year prior to study enrollment
- Presence of inflammation at the proposed injection site(s)
- Profound atrophy/excessive weakness of muscles in target areas of injection
- Known immunization or hypersensitivity to any botulinum toxin serotype
- Undergone oral surgery or dental procedures within 30 days
- No visible eyelashes
- Use of permanent eyeliner, eyelash implants, semi-permanent eyelash tint, dye or extension
- Use of prescription eyelash growth products
- Unwilling or unable to remove contact lenses prior to study medication application in the evening and keep lenses out for 30 minutes
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: All Participants
JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable.
LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
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onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.
Other Names:
bimatoprost ophthalmic solution 0.03% (LATISSE®) 1 drop applied to the upper eyelid at the base of eyelashes once daily in the evening for 17 weeks.
Other Names:
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
Time Frame: Baseline, Month 4
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Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire.
Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied.
The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best).
A positive change from Baseline indicates improvement.
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Baseline, Month 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Aging Appearance Using a 7-item Questionnaire
Time Frame: Baseline, Month 4
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Participants rated how they look now using a 7-item questionnaire.
Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree.
The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best).
A positive change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
Time Frame: Baseline, Month 4
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Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older).
A positive change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in Social Confidence Using an 8-item Questionnaire
Time Frame: Baseline, Month 4
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Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire.
Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree.
The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best).
A positive change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
Time Frame: Baseline, Month 4
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Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire.
Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree.
The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best).
A positive change from Baseline indicates improvement.
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Baseline, Month 4
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Participant's Self- Perception of Age (SPA)
Time Frame: Baseline, Month 4
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Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today?
Participants recorded how many years younger or older they thought their facial appearance made them look.
A negative result indicates improvement (a younger appearance).
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Baseline, Month 4
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Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)
Time Frame: Baseline, Month 4
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The investigator assessed the severity of the participant's GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe.
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS
Time Frame: Baseline, Month 4
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The investigator assessed the severity of the participant's CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe.
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
Time Frame: Baseline, Month 4
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The investigator assessed the participant's eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best).
A positive change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS
Time Frame: Baseline, Month 4
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The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) [best], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) [worst].
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
Time Frame: Baseline, Month 4
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The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) [best], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle).
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
Time Frame: Baseline, Month 4
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The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe.
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
Time Frame: Baseline, Month 4
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The investigator assessed the participant's perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) [best], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)[worst].
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
Time Frame: Baseline, Month 4
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Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ).
Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36.
A negative change from Baseline indicates improvement.
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Baseline, Month 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
June 30, 2014
Primary Completion (Actual)
May 3, 2015
Study Completion (Actual)
May 3, 2015
Study Registration Dates
First Submitted
June 25, 2014
First Submitted That Met QC Criteria
June 25, 2014
First Posted (Estimate)
June 27, 2014
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
December 19, 2018
Last Verified
December 1, 2018
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
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Immunologic Factors
- Protective Agents
- Membrane Transport Modulators
- Adjuvants, Immunologic
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Pharmaceutical Solutions
- Viscosupplements
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- Ophthalmic Solutions
- Hyaluronic Acid
- Bimatoprost
Other Study ID Numbers
- GMA-CMB-14-001
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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