Facial RhytidesPhase 4NCT02176356
Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
A Phase 4 study testing onabotulinumtoxinA, bimatoprost ophthalmic solution 0.03% and JUVÉDERM® ULTRA XC in people with Facial Rhytides and Crow's Feet Lines, run by Allergan at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Facial Rhytides, Crow's Feet Lines, Glabellar Lines
- What is being tested?
- onabotulinumtoxinA, bimatoprost ophthalmic solution 0.03% and JUVÉDERM® ULTRA XC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2014to 3 May 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Facial Rhytides, Crow's Feet Lines, Glabellar Lines, Nasolabial Fold
- Being tested
- onabotulinumtoxinA, bimatoprost ophthalmic solution 0.03%, JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS XC, JUVÉDERM® VOLUMA® XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinABiological
Also called botulinum toxin Type A
onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.
bimatoprost ophthalmic solution 0.03%Drug
Also called LATISSE®
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.
JUVÉDERM® ULTRA XCDevice
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® ULTRA PLUS XCDevice
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® VOLUMA® XCDevice
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | 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. Receives: Biological: onabotulinumtoxinA; Drug: bimatoprost ophthalmic solution 0.03%; Device: JUVÉDERM® ULTRA XC; Device: JUVÉDERM® ULTRA PLUS XC; Device: JUVÉDERM® VOLUMA® XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
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.
Measured: Baseline, Month 4
Secondary outcomes (13)
Change From Baseline in Aging Appearance Using a 7-item Questionnaire
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.
Measured: Baseline, Month 4
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
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.
Measured: Baseline, Month 4
Change From Baseline in Social Confidence Using an 8-item Questionnaire
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.
Measured: Baseline, Month 4
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
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.
Measured: Baseline, Month 4
Participant's Self- Perception of Age (SPA)
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).
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline, Month 4
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
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.
Measured: 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
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.
Measured: Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
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.
Measured: Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
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.
Measured: Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
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.
Measured: Baseline, Month 4
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
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.
Measured: Baseline, Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start30 Jun 2014
- Primary completion3 May 2015
- Study completion3 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial RhytidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176356
- Sponsor's protocol ID
- GMA-CMB-14-001
- Status last verified
- Dec 2018
- First submitted
- 25 Jun 2014
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weinkle SH, Werschler WP, Teller CF, Sykes JM, Shamban A, Rivkin A, Narurkar VA, Kaminer MS, Dayan S, Cohen JL, Gallagher CJ. Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study. Aesthet Surg J. 2018 Apr 6;38(5):540-556. doi: 10.1093/asj/sjx179.
PubMed 29244069
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
- ClinicalTrials.gov ID
- NCT02176356
- Acronym / sponsor ID
- GMA-CMB-14-001
- Conditions
- Facial Rhytides, Crow's Feet Lines, Glabellar Lines, Nasolabial Fold
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 3 May 2015 (actual)
- Study completion
- 3 May 2015 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 16 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Biological: onabotulinumtoxinA, Drug: bimatoprost ophthalmic solution 0.03%, Device: JUVÉDERM® ULTRA XC, Device: JUVÉDERM® ULTRA PLUS XC, Device: JUVÉDERM® VOLUMA® XCJUVÉDERM® 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| onabotulinumtoxinAAlso: botulinum toxin Type AonabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas. | Biological | All Participants |
| bimatoprost ophthalmic solution 0.03%Also: LATISSE®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. | Drug | All Participants |
| JUVÉDERM® ULTRA XCJUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator. | Device | All Participants |
| JUVÉDERM® ULTRA PLUS XCJUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator. | Device | All Participants |
| JUVÉDERM® VOLUMA® XCJUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator. | Device | All Participants |
Primary outcome
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.
13 secondary outcomes
Change From Baseline in Aging Appearance Using a 7-item Questionnaire
Time frame: Baseline, Month 4
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
Time frame: Baseline, Month 4
Change From Baseline in Social Confidence Using an 8-item Questionnaire
Time frame: Baseline, Month 4
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
Time frame: Baseline, Month 4
Participant's Self- Perception of Age (SPA)
Time frame: 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
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
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
Time frame: 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
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
Time frame: Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
Time frame: Baseline, Month 4
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
Time frame: Baseline, Month 4
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
Time frame: Baseline, Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29244069Weinkle SH, Werschler WP, Teller CF, Sykes JM, Shamban A, Rivkin A, Narurkar VA, Kaminer MS, Dayan S, Cohen JL, Gallagher CJ. Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study. Aesthet Surg J. 2018 Apr 6;38(5):540-556. doi: 10.1093/asj/sjx179.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing onabotulinumtoxinA, bimatoprost ophthalmic solution 0.03% and JUVÉDERM® ULTRA XC in people with Facial Rhytides and Crow's Feet Lines, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire (time frame: Baseline, Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02176356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.