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

• ClinicalTrials.gov Identifier: NCT02176356
• Recruitment Status: Completed
• First Posted: June 27, 2014
• Results First Posted: June 16, 2016
• Last Update Posted: January 9, 2019
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Facial Rhytides; Crow's Feet Lines; Glabellar Lines; Nasolabial Fold	Biological: onabotulinumtoxinA; Drug: bimatoprost ophthalmic solution 0.03%; Device: JUVÉDERM® ULTRA XC; Device: JUVÉDERM® ULTRA PLUS XC; Device: JUVÉDERM® VOLUMA® XC	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: June 30, 2014
• Actual Primary Completion Date: May 3, 2015
• Actual Study Completion Date: May 3, 2015

Arms and Interventions

Arm

Intervention/treatment

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.

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.; Other Name: botulinum toxin Type A; 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.; Other Name: LATISSE®; Device: JUVÉDERM® ULTRA XC; JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.; Device: JUVÉDERM® ULTRA PLUS XC; JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.; Device: JUVÉDERM® VOLUMA® XC; JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Los Angeles, California, United States

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

Publications:

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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02176356
• Other Study ID Numbers: GMA-CMB-14-001
• First Posted: June 27, 2014
• Results First Posted: June 16, 2016
• Last Update Posted: January 9, 2019
• Last Verified: December 2018

Additional relevant MeSH terms:

Facies; Disease Attributes; Pathologic Processes; Bimatoprost; Ophthalmic Solutions; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Hyaluronic Acid; Pharmaceutical Solutions; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents; Antihypertensive Agents; Adjuvants, Immunologic; Immunologic Factors; Viscosupplements; Protective Agents