Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
NCT ID: NCT02176356
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
116 participants
INTERVENTIONAL
2014-06-30
2015-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
JUVÉDERM® ULTRA XC
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® ULTRA PLUS XC
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Interventions
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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.
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.
JUVÉDERM® ULTRA XC
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® ULTRA PLUS XC
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
65 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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GMA-CMB-14-001
Identifier Type: -
Identifier Source: org_study_id
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