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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Los Angeles, California, United States

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: onabotulinumtoxinA
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:
  • botulinum toxin Type A
Drug: bimatoprost ophthalmic solution 0.03%
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:
  • LATISSE®
Device: JUVÉDERM® ULTRA XC
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Device: JUVÉDERM® ULTRA PLUS XC
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Device: JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
Baseline, Month 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Aging Appearance Using a 7-item Questionnaire
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Change From Baseline in Social Confidence Using an 8-item Questionnaire
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Participant's Self- Perception of Age (SPA)
Time Frame: Baseline, Month 4
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).
Baseline, Month 4
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
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.
Baseline, Month 4
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
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.
Baseline, Month 4
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
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
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.
Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
Time Frame: Baseline, Month 4
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.
Baseline, Month 4
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
Time Frame: Baseline, Month 4
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.
Baseline, Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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