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NCT01970397 · ClinicalTrials.gov registry record · NA

JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines

A NA study, sponsored by Allergan.

Completed
Registry status
NA
Development phase
138
Enrollment target

NCT01970397: Completed NA study, sponsored by Allergan.

NCT01970397 is a NA study that has completed, run by Allergan. The registered enrollment target is 138 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01970397, a NA study, has completed, sponsored by Allergan.

COMPLETED
Registry status
NA
Development phase
138 participants
Enrollment target

Study Summary

A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines

Primary Outcome

The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.

Interventions

  • DEVICE Belotero Balance®
  • DEVICE JUVEDERM® Ultra XC

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2013-10-21
Est. Completion 2014-08-04
Phase NA
Allergan

314 total trials

What the finished NCT01970397 record still lists

NCT01970397 is an interventional study that assigns participants to a tested intervention. The registered 138 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 (90% lower).

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

NCT01970397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01970397 about?

NCT01970397 is a clinical study titled "JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines". A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines

What is the current status of trial NCT01970397?

This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2013-10-21. Estimated completion is 2014-08-04.

What interventions are being tested in trial NCT01970397?

The interventions under investigation include: Belotero Balance® (DEVICE), JUVEDERM® Ultra XC (DEVICE).

Who is sponsoring clinical trial NCT01970397?

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

How this trial's enrollment target compares

Where NCT01970397's enrollment target sits among peer trials

138 720th of 2000 higher than 1,279 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 NCT01970397, the US trial registry maintained by the National Library of Medicine. NCT01970397 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.