Overview

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

Status:
Completed
Trial end date:
2015-05-03
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
abobotulinumtoxinA
Bimatoprost
Botulinum Toxins
Botulinum Toxins, Type A
Hyaluronic Acid
incobotulinumtoxinA
onabotulinumtoxinA
Ophthalmic Solutions
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.