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

Allergan

Status and phase: Completed; Phase 4

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176356

GMA-CMB-14-001

Details and patient eligibility

About

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).

Enrollment: 116 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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116 participants in 1 patient group

All Participants

Other group

Description:

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.

Treatment:

Device: JUVÉDERM® VOLUMA® XC

Drug: bimatoprost ophthalmic solution 0.03%

Device: JUVÉDERM® ULTRA XC

Biological: onabotulinumtoxinA

Device: JUVÉDERM® ULTRA PLUS XC