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NCT03728309 · ClinicalTrials.gov registry record · NA
JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness
A NA study of Skin Smoothness of the Cheeks, sponsored by Allergan.
- Completed
- Registry status
- NA
- Development phase
- 209
- Enrollment target
- 14
- Study locations
NCT03728309: Completed NA study of Skin Smoothness of the Cheeks, sponsored by Allergan.
NCT03728309 is a NA study of Skin Smoothness of the Cheeks that has completed, run by Allergan. The registered enrollment target is 209 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03728309, a NA study of Skin Smoothness of the Cheeks, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- NA
- Development phase
- 209 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.
Primary Outcome
The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latte
Conditions Studied
Interventions
- DEVICE JUVÉDERM VOLITE™ XC
Study Locations (14)
California
- Kathleen L. Behr M.D. Inc /ID# 236170 - Fresno
- Dermatology Research Associates /ID# 237649 - Los Angeles
- Ava MD - Santa Monica
- Art of Skin MD - Solana Beach
Massachusetts
- Skincare Physicians /ID# 235383 - Chestnut Hill
- Dermatology PartnersInc. /ID# 234946 - Wellesley
Florida
- Skin Research Institute LLC - Coral Gables
Illinois
- Advanced Dermatology /ID# 234879 - Lincolnshire
Maryland
- Facial Plastic Surgery Center /ID# 234876 - Baltimore
New York
- Dermatology and Laser Surgery Center of New York /ID# 234571 - New York
North Carolina
- Dermatology Laser and Vein Specialists of Carolinas /ID# 236169 - Charlotte
South Carolina
- Clinical Research Center of the Carolinas /ID# 236488 - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2020-07-17 |
| Phase | NA |
What the finished NCT03728309 record still lists
NCT03728309 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Skin Smoothness of the Cheeks appearing as the primary indexed condition, and to 1 intervention - of which JUVÉDERM VOLITE™ XC is the first listed.
NCT03728309 lists 14 locations in 10 states (California, Massachusetts, Florida).
Frequently Asked Questions
What is clinical trial NCT03728309 about?
NCT03728309 is a clinical study titled "JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness". This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.
What is the current status of trial NCT03728309?
This trial is currently completed. It is a NA study. The enrollment target is 209 participants. The study started on 2018-11-09. Estimated completion is 2020-07-17.
What conditions does trial NCT03728309 study?
This clinical trial studies the following conditions: Skin Smoothness of the Cheeks.
What interventions are being tested in trial NCT03728309?
The interventions under investigation include: JUVÉDERM VOLITE™ XC (DEVICE).
Who is sponsoring clinical trial NCT03728309?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03728309 being conducted?
This trial has 14 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03728309's enrollment target sits among peer trials
209 496th of 2000 higher than 1,505 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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