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

NCT02176356 | Completed Phase 4 Results

• 1 other identifier: GMA-CMB-14-001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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 Social Confidence Using an 8-item Questionnaire

  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

Study Arms (1)

All Participants

OTHER

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; Drug: bimatoprost ophthalmic solution 0.03%; Device: JUVÉDERM® ULTRA XC; Device: JUVÉDERM® ULTRA PLUS XC; Device: JUVÉDERM® VOLUMA® XC

Interventions

onabotulinumtoxinA BIOLOGICAL

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

Also known as: botulinum toxin Type A

All Participants

bimatoprost ophthalmic solution 0.03% DRUG

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.

Also known as: LATISSE®

All Participants

JUVÉDERM® ULTRA XC DEVICE

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

All Participants

JUVÉDERM® ULTRA PLUS XC DEVICE

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

All Participants

JUVÉDERM® VOLUMA® XC DEVICE

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

All Participants

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Los Angeles, California, United States

Location

Related 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.

  PMID: 29244069 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A; Bimatoprost

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: June 30, 2014
• Primary Completion: May 3, 2015
• Study Completion: May 3, 2015
• Last Updated: January 9, 2019
• Results First Posted: June 16, 2016

Record last verified: 2018-12

Locations

US (1)