Phase 4 N=116 Single-blind Treatment

Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)

Facial Rhytides · Crow's Feet Lines · Glabellar Lines · Nasolabial Fold

Bottom Line

View on ClinicalTrials.gov: NCT02176356 ↗

Enrolled (actual)

116

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire — 41.22; 31.70 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: onabotulinumtoxinA (Biological); bimatoprost ophthalmic solution 0.03% (Drug); JUVÉDERM® ULTRA XC (Device); JUVÉDERM® ULTRA PLUS XC (Device); JUVÉDERM® VOLUMA® XC (Device)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Allergan
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire	41.22; 31.70	—
SECONDARY Change From Baseline in Aging Appearance Using a 7-item Questionnaire	45.07; 28.47	—
SECONDARY Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)	0.1; -4.6	—
SECONDARY Change From Baseline in Social Confidence Using an 8-item Questionnaire	62.70; 18.24	—
SECONDARY Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire	62.78; 19.89	—
SECONDARY Participant's Self- Perception of Age (SPA)	0.2; -4.6	—
SECONDARY Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)	2.6; -1.6	—
SECONDARY Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS	2.5; -1.0; 2.5; -1.0	—
SECONDARY Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)	1.8; 1.5	—
SECONDARY Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS	3.1; -1.7	—
SECONDARY Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity	2.6; -1.0	—
SECONDARY Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity	2.1; -0.9	—
SECONDARY Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity	2.0; -1.1	—
SECONDARY Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area	21.1; -12.6	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02176356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.