Trial Outcomes & Findings for Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study) (NCT NCT02176356)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

116 participants

Primary outcome timeframe

Baseline, Month 4

Results posted on

2019-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	116
Overall Study Eligible and Received Treatment	100
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Screen Failure	14
Overall Study Lost to Follow-up	4
Overall Study Personal Reasons	3
Overall Study Other Miscellaneous Reasons	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=100 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.
Age, Continuous	52.5 years STANDARD_DEVIATION 7.40 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 4

Population: Modified Intent-to-Treat (mITT) population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire Baseline	41.22 score on a scale Standard Deviation 11.97
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire Change from Baseline at Month 4	31.70 score on a scale Standard Deviation 20.00

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in Aging Appearance Using a 7-item Questionnaire Baseline	45.07 score on a scale Standard Deviation 18.85
Change From Baseline in Aging Appearance Using a 7-item Questionnaire Change from Baseline at Month 4	28.47 score on a scale Standard Deviation 21.47

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS) Baseline	0.1 years Standard Deviation 4.28
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS) Change from Baseline at Month 4 (n=92)	-4.6 years Standard Deviation 4.36

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in Social Confidence Using an 8-item Questionnaire Baseline	62.70 score on a scale Standard Deviation 21.74
Change From Baseline in Social Confidence Using an 8-item Questionnaire Change from Baseline at Month 4	18.24 score on a scale Standard Deviation 23.04

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire Baseline	62.78 score on a scale Standard Deviation 22.45
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire Change from Baseline at Month 4	19.89 score on a scale Standard Deviation 20.63

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.

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).

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Participant's Self- Perception of Age (SPA) Baseline	0.2 years Standard Deviation 4.08
Participant's Self- Perception of Age (SPA) Month 4	-4.6 years Standard Deviation 4.19

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=89 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.
Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS) Baseline	2.6 score on a scale Standard Deviation 0.50
Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS) Change from Baseline at Month 4	-1.6 score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=90 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.
Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS Left_Baseline	2.5 score on a scale Standard Deviation 0.50
Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS Left_Change from Baseline at Month 4	-1.0 score on a scale Standard Deviation 0.85
Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS Right_Baseline	2.5 score on a scale Standard Deviation 0.50
Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS Right_Change from Baseline at Month 4	-1.0 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS) Baseline	1.8 score on a scale Standard Deviation 0.42
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS) Change from Baseline at Month 4	1.5 score on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=89 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.
Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS Baseline	3.1 score on a scale Standard Deviation 0.36
Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS Change from Baseline at Month 4	-1.7 score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=90 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.
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity Baseline	2.6 score on a scale Standard Deviation 0.51
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity Change from Baseline at Month 4	-1.0 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=86 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.
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity Baseline	2.1 score on a scale Standard Deviation 0.49
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity Change from Baseline at Month 4	-0.9 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=59 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.
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity Baseline	2.0 score on a scale Standard Deviation 0.57
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity Change from Baseline at Month 4	-1.1 score on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	All Participants n=93 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.
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area Baseline	21.1 score on a scale Standard Deviation 6.71
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area Change from Baseline at Month 4	-12.6 score on a scale Standard Deviation 7.61

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=100 participants at risk 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.
Injury, poisoning and procedural complications Contusion	18.0% 18/100 The Safety population, all enrolled participants who received treatment with any study drug, was used to determine the number of participants at risk for Serious Adverse Events and Non-Serious Adverse Events.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER