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NCT02176356 · ClinicalTrials.gov registry record · Phase 4
Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
A Phase 4 study of Glabellar Lines and Facial Rhytides, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 116
- Enrollment target
- 1
- Study location
NCT02176356: Completed Phase 4 study of Glabellar Lines and Facial Rhytides, sponsored by Allergan.
NCT02176356 is a Phase 4 study of Glabellar Lines and Facial Rhytides that has completed, run by Allergan. The registered enrollment target is 116 participants, below the 385-participant average among 4 other Glabellar Lines trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02176356, a Phase 4 study of Glabellar Lines and Facial Rhytides, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 116 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG bimatoprost ophthalmic solution 0.03%
- BIOLOGICAL onabotulinumtoxinA
- DEVICE JUVÉDERM® ULTRA XC
- DEVICE JUVÉDERM® ULTRA PLUS XC
- DEVICE JUVÉDERM® VOLUMA® XC
Study Locations (1)
California
- - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2014-06-30 |
| Est. Completion | 2015-05-03 |
| Phase | Phase 4 |
What the finished NCT02176356 record still lists
NCT02176356 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 385-participant average among 4 other Glabellar Lines trials with a reported enrollment target (70% lower).
The record links to 4 conditions, with Glabellar Lines appearing as the primary indexed condition, and to 5 interventions - of which bimatoprost ophthalmic solution 0.03% is the first listed.
NCT02176356 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02176356 about?
NCT02176356 is a clinical study titled "Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)". 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).
What is the current status of trial NCT02176356?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2014-06-30. Estimated completion is 2015-05-03.
What conditions does trial NCT02176356 study?
This clinical trial studies the following conditions: Glabellar Lines, Facial Rhytides, Crow's Feet Lines, Nasolabial Fold.
What interventions are being tested in trial NCT02176356?
The interventions under investigation include: bimatoprost ophthalmic solution 0.03% (DRUG), onabotulinumtoxinA (BIOLOGICAL), JUVÉDERM® ULTRA XC (DEVICE), JUVÉDERM® ULTRA PLUS XC (DEVICE), JUVÉDERM® VOLUMA® XC (DEVICE).
Who is sponsoring clinical trial NCT02176356?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02176356 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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