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NCT01998581 · ClinicalTrials.gov registry record · NA

A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement

A NA study, sponsored by Allergan.

Completed
Registry status
NA
Development phase
225
Enrollment target

NCT01998581: Completed NA study, sponsored by Allergan.

NCT01998581 is a NA study that has completed, run by Allergan. The registered enrollment target is 225 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01998581, a NA study, has completed, sponsored by Allergan.

COMPLETED
Registry status
NA
Development phase
225 participants
Enrollment target

Study Summary

This is a multicenter, double-blind, randomized, controlled study of the safety and effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and perioral enhancement.

Primary Outcome

Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.

Interventions

  • DEVICE Restylane-L®
  • DEVICE JUVEDERM VOLBELLA® XC

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2013-11-01
Est. Completion 2015-05-29
Phase NA
Allergan

314 total trials

What the finished NCT01998581 record still lists

NCT01998581 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Restylane-L® is the first listed.

NCT01998581 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01998581 about?

NCT01998581 is a clinical study titled "A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement". This is a multicenter, double-blind, randomized, controlled study of the safety and effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and perioral enhancement.

What is the current status of trial NCT01998581?

This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2013-11-01. Estimated completion is 2015-05-29.

What interventions are being tested in trial NCT01998581?

The interventions under investigation include: Restylane-L® (DEVICE), JUVEDERM VOLBELLA® XC (DEVICE).

Who is sponsoring clinical trial NCT01998581?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01998581's enrollment target sits among peer trials

225 472nd of 2000 higher than 1,523 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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Source: ClinicalTrials.gov NCT01998581, the US trial registry maintained by the National Library of Medicine. NCT01998581 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.