CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 117 enrolled
Drug / intervention
Belotero®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01635855
NCT01635855Phase 4Completed
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Belotero® Post Approval Study for the Treatment of Nasolabial Folds

Merz North America, Inc.·interventional·Posted Jul 10, 2012·Updated Jul 4, 2014

In Brief

A Phase 4 clinical trial evaluating Belotero® for Nasolabial Folds. Completed, enrolled 117 participants across 9 sites.

Detailed Summary

A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Folds
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2012
Enrollment StartJun 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.0 years ago

Interventions

Belotero®device

Hyaluronic acid dermal filler