VOLITE XC for Neck Lines

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Neck LinesVOLITE XC - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is being conducted to assess the safety and effectiveness of VOLITE XC, an injectable gel, for the improvement of horizontal neck lines.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 10 Months

Baseline to Month 1
Change from baseline to Month 1 on FACE-Q Appraisal of Neck Lines questionnaire
Month 1
Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS
Percentage of Participants Achieving "Responder" status based on Evaluating Investigator's (EI) live assessment of transverse neck lines using the Allergan Transverse Neck Lines Scale (ATNLS)
Up to 10 Months
Number of Participants with Adverse Events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Treatment
8%knee pain
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT01895959) in the Treatment ARM group. Side effects include: knee pain with 8%.

Trial Design

1 Treatment Group

VOLITE XC
1 of 1

Experimental Treatment

212 Total Participants · 1 Treatment Group

Primary Treatment: VOLITE XC · No Placebo Group · Phase 3

VOLITE XC
Device
Experimental Group · 1 Intervention: VOLITE XC · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 months

Who is running the clinical trial?

AbbVieLead Sponsor
833 Previous Clinical Trials
470,897 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
303 Previous Clinical Trials
118,184 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection.
You have moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.

Who else is applying?

What state do they live in?
New York57.1%
Louisiana14.3%
California14.3%
Other14.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Cosmetic Laser Dermatology /ID# 23912116.7%
Delricht Research /ID# 24200116.7%
Skin And Aesthetics Surgery Of Manhattan /ID# 24360750.0%
Other16.7%
What portion of applicants met pre-screening criteria?
Met criteria85.7%
Did not meet criteria14.3%