Clinical trial NCT02176356: Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Rhytides
Crow's Feet Lines
Glabellar Lines
Nasolabial Fold
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 116
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Change From Baseline in Aging Appearance Using a 7-item Questionnaire
timeFrame: Baseline, Month 4
measure: Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Social Confidence Using an 8-item Questionnaire
timeFrame: Baseline, Month 4
measure: Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
timeFrame: Baseline, Month 4
measure: Participant's Self- Perception of Age (SPA)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS
timeFrame: Baseline, Month 4
measure: Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
timeFrame: Baseline, Month 4
measure: Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS
timeFrame: Baseline, Month 4
measure: Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
timeFrame: Baseline, Month 4
measure: Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
timeFrame: Baseline, Month 4
measure: Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
timeFrame: Baseline, Month 4
measure: Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
timeFrame: Baseline, Month 4
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.