Allergan Vollure for Atrophy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrophy+1 More
Allergan Vollure - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing Juvéderm Vollure, a new injectable filler, to see if it is safe and effective. Subjects will get Juvéderm Vollure on one side of their face and Saline on the other side. They will come back 30 days later and possibly get the Juvéderm Vollure again. They will fill out questionnaires and be assessed for short-term and long-term adverse events.

Eligible Conditions
  • Atrophy
  • Atrophic Scar

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline to 90 days after last injection

Month 24
24 Month Global Aesthetic Improvement Scale (GAIS) Results
24 Month Quantitiative Global Scaring Grading System (QGSGS) Results
Day 90
Adverse Events
Global Aesthetic Improvement Scale (GAIS)
Quantitiative Global Scaring Grading System (QGSGS) score
Result of Placebo Group based on the Quantitiative Global Scaring Grading System (QGSGS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment With Juvederm Vollure Right
1 of 2
Treatment Juvederm Vollure Left
1 of 2

Experimental Treatment

15 Total Participants · 2 Treatment Groups

Primary Treatment: Allergan Vollure · No Placebo Group · N/A

Treatment With Juvederm Vollure Right
Device
Experimental Group · 1 Intervention: Allergan Vollure · Intervention Types: Device
Treatment Juvederm Vollure Left
Device
Experimental Group · 1 Intervention: Allergan Vollure · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 90 days after last injection

Who is running the clinical trial?

AllerganIndustry Sponsor
780 Previous Clinical Trials
276,143 Total Patients Enrolled
2 Trials studying Atrophy
429 Patients Enrolled for Atrophy
Siperstein DermatologyLead Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The individual scores a 4-55 on a validated scarring grading system.
The person is generally in good health, as evidenced by their past medical history.
For women of childbearing age, using effective contraception and a negative pregnancy test at every screening and injection visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.