Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
Overview
- Phase
- Phase 4
- Intervention
- onabotulinumtoxinA
- Conditions
- Facial Rhytides
- Sponsor
- Allergan
- Enrollment
- 116
- Primary Endpoint
- Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
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
Arms & Interventions
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.
Intervention: onabotulinumtoxinA
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.
Intervention: bimatoprost ophthalmic solution 0.03%
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.
Intervention: JUVÉDERM® ULTRA XC
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.
Intervention: JUVÉDERM® ULTRA PLUS XC
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.
Intervention: JUVÉDERM® VOLUMA® XC
Outcomes
Primary Outcomes
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
Time Frame: 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 Outcomes
- Change From Baseline in Aging Appearance Using a 7-item Questionnaire(Baseline, Month 4)
- Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)(Baseline, Month 4)
- Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire(Baseline, Month 4)
- Participant's Self- Perception of Age (SPA)(Baseline, Month 4)
- Change From Baseline in Social Confidence Using an 8-item Questionnaire(Baseline, Month 4)
- Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity(Baseline, Month 4)
- 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)
- 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)
- Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)(Baseline, Month 4)
- 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)
- Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity(Baseline, Month 4)
- Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity(Baseline, Month 4)
- Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area(Baseline, Month 4)