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

Glabellar Lines Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176356
• Other study ID #: GMA-CMB-14-001
• Status: Completed
• Phase: Phase 4
• Start date: June 30, 2014
• Est. completion date: May 3, 2015

Study information

• Verified date: December 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 3, 2015
• Est. primary completion date: May 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• onabotulinumtoxinA
onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.

Drug:
• bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% (LATISSE®) 1 drop applied to the upper eyelid at the base of eyelashes once daily in the evening for 17 weeks.

Device:
• JUVÉDERM® ULTRA XC
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
• JUVÉDERM® ULTRA PLUS XC
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
• JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire	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.	Baseline, Month 4
Secondary	Change From Baseline in Aging Appearance Using a 7-item Questionnaire	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.	Baseline, Month 4
Secondary	Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)	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.	Baseline, Month 4
Secondary	Change From Baseline in Social Confidence Using an 8-item Questionnaire	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.	Baseline, Month 4
Secondary	Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire	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.	Baseline, Month 4
Secondary	Participant's Self- Perception of Age (SPA)	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).	Baseline, Month 4
Secondary	Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)	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.	Baseline, Month 4
Secondary	Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS	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.	Baseline, Month 4
Secondary	Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)	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.	Baseline, Month 4
Secondary	Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS	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.	Baseline, Month 4
Secondary	Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity	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.	Baseline, Month 4
Secondary	Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity	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.	Baseline, Month 4
Secondary	Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity	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.	Baseline, Month 4
Secondary	Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area	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.	Baseline, Month 4