Last reviewed · How we verify

NCT04971876

Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

Completed NA Last updated 3 November 2022
What this trial tests

NA trial testing HLR-1 in Lips Enhancement in 132 participants. Completed in 6 September 2022.

Timeline
27 October 2020
Primary endpoint
11 August 2022
6 September 2022

Quick facts

Lead sponsorHallura Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment132
Start date27 October 2020
Primary completion11 August 2022
Estimated completion6 September 2022
Sites3 locations across Germany, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Hallura Ltd.

Who can join

21 and older, any sex, with Lips Enhancement or Nasolabial Fold Correction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Twelve-Month Outcome of Nasolabial Fold Correction by a Novel Non-1,4-Butanediol Diglycidyl Ether, Click-Crosslinked, Long-Chain Hyaluronic Acid Product.
    Safir A, Sattler S, Da Mota R, Kowalska-Olędzka E, et al · · 2026 · PMID 42029422 · DOI 10.1111/jocd.70840

Verify or expand the search:

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04971876.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing