Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
Condition: Facial Rhytides; Crow's Feet Lines; Glabellar Lines; Nasolabial Fold
MeSH terms: Facies
Intervention: onabotulinumtoxinA; bimatoprost ophthalmic solution 0.03%; JUVÉDERM® ULTRA XC; JUVÉDERM® ULTRA PLUS XC; JUVÉDERM® VOLUMA® XC
Intervention description: onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.; 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.; JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.; JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.; JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Intervention MeSH terms: Bimatoprost; Ophthalmic Solutions; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: No

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).
    

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

          -  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.