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

Phase 4

Completed

Conditions: Glabellar Lines
Facial Rhytides
Crow's Feet Lines
Nasolabial Fold

Interventions: Biological: onabotulinumtoxinA
Drug: bimatoprost ophthalmic solution 0.03%
Device: JUVÉDERM® ULTRA XC
Device: JUVÉDERM® ULTRA PLUS XC
Device: JUVÉDERM® VOLUMA® XC

Registration Number: NCT02176356

Lead Sponsor: Allergan

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	onabotulinumtoxinA	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.
All Participants	JUVÉDERM® ULTRA XC	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.
All Participants	JUVÉDERM® ULTRA PLUS XC	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.
All Participants	bimatoprost ophthalmic solution 0.03%	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.
All Participants	JUVÉDERM® VOLUMA® XC	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity	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.
Change From Baseline in Aging Appearance Using a 7-item Questionnaire	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.
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)	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.
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire	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.
Participant's Self- Perception of Age (SPA)	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).
Change From Baseline in Social Confidence Using an 8-item Questionnaire	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.
Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)	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.
Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS	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.
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)	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.
Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS	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.
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity	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.
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity	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.
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area	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.