CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 116 enrolled
Drug / intervention
onabotulinumtoxinA +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02176356
NCT02176356Phase 4Completed
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Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)

Allergan·interventional·Posted Jun 27, 2014·Updated Jan 9, 2019

In Brief

A Phase 4 clinical trial evaluating onabotulinumtoxinA, bimatoprost ophthalmic solution 0.03%, and 3 other interventions for Facial Rhytides and 3 related conditions. Completed, enrolled 116 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytides, Crow's Feet Lines, Glabellar Lines, Nasolabial Fold
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 27, 2014
Enrollment StartJun 30, 2014
Primary CompletionMay 3, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.0 years ago

Interventions

onabotulinumtoxinAbiological

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%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.

JUVÉDERM® ULTRA XCdevice

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

JUVÉDERM® ULTRA PLUS XCdevice

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

JUVÉDERM® VOLUMA® XCdevice

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