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NCT03425721 · ClinicalTrials.gov registry record

Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers

A clinical trial, sponsored by Allergan.

Completed
Registry status
17
Enrollment target

NCT03425721: Completed study, sponsored by Allergan.

NCT03425721 is a clinical trial that has completed, run by Allergan. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03425721 has completed, sponsored by Allergan.

COMPLETED
Registry status
17 participants
Enrollment target

Study Summary

This study will determine if HA dermal filler late occurring (\> 4 weeks and \<2 years) nodules are associated with bacterial contamination (independent of filler type) and to characterize the histological response.

Primary Outcome

Histological lab assessment of biopsy sample for analysis of Hematoxylin and eosin (H\&E), orcein, periodic acid-Schiff, gram stain and immunohistochemistry (IHC), with a histopathology assessment to identify possible presence and location of bacteria, mycobacteria, fungus, mold, and/or yeast and the immune/inflammation response within the biopsy.

Interventions

  • OTHER No Intervention

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2017-11-21
Est. Completion 2021-04-13
Allergan

314 total trials

What the finished NCT03425721 record still lists

NCT03425721 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which No Intervention is the first listed.

NCT03425721 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03425721 about?

NCT03425721 is a clinical study titled "Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers". This study will determine if HA dermal filler late occurring (\> 4 weeks and \<2 years) nodules are associated with bacterial contamination (independent of filler type) and to characterize the histological response.

What is the current status of trial NCT03425721?

This trial is currently completed. The enrollment target is 17 participants. The study started on 2017-11-21. Estimated completion is 2021-04-13.

What interventions are being tested in trial NCT03425721?

The interventions under investigation include: No Intervention (OTHER).

Who is sponsoring clinical trial NCT03425721?

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

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Source: ClinicalTrials.gov NCT03425721, the US trial registry maintained by the National Library of Medicine. NCT03425721 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.