CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
BOTOX Cosmetic® +3 moredrug
Likely dose
BELKYRA® 100 mgfrom 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/NCT03712449
NCT03712449Phase 4Completed
CompareCT.gov

Canada Global HARMONY: Prospective, Multi-site, Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment

Allergan·interventional·Posted Oct 19, 2018·Updated Oct 31, 2023

In Brief

A Phase 4 clinical trial evaluating JUVÉDERM®, BOTOX Cosmetic®, and 2 other interventions for Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality. Completed, enrolled 59 participants across 7 sites.

Detailed Summary

The objective of this study is to quantify the psychological and emotional impact of comprehensive aesthetic treatment with a portfolio of Allergan products by measuring the change in participant's satisfaction with facial appearance from baseline to the final study visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytides, Skin Folds, Loss of Volume and Skin Quality
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 19, 2018
Enrollment StartJan 22, 2019
Primary CompletionJul 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.7 years ago

Interventions

JUVÉDERM®device

Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).

BOTOX Cosmetic®drug

BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).

BELKYRA®drug

BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).

SkinMedicaother

SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).