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

Completed

• Conditions: Dermal Nodule

• Registration Number: NCT03425721
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-21
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Have only received HA fillers (no limitation on the brand(s)/product(s) of HA filler used; multiple product use is allowed).
• Present with an unresolved nodule (inflammatory or non-inflammatory) which was first observed > 4 weeks and > 2 years after most recent HA filler treatment and is determined to be greater than 3 millimeters (mm) in diameter by palpation

Exclusion Criteria

• Have received non-HA fillers (e.g. polyacrylamide, calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene, collagen) including mixes with HA fillers anywhere in the face.
• Are currently enrolled in a dermal filler clinical trial or previously enrolled in a dermal filler clinical trial with randomized treatment in which the type of dermal filler is unknown (i.e. non-HA filler arm of study).
• Have history of keloid or hypertrophic scarring
• Have received intralesional intervention for the nodule (e.g. hyaluronidase, corticosteroids, antibiotics, 5-fluorouracil).
• Are pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological Sampling	12 Weeks	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.
Microbiological Sampling	12 Weeks	Microbiology lab assessment of biopsy sample for analysis of the presence and species of bacteria/mycobacteria within the biopsy.

Trial Locations

Locations (2)

Skin Care and Laser Physicians (SCLP) of Beverly Hills; 🇺🇸 West Hollywood, California, United States

Assure Surgical, P.C.; 🇺🇸 New York, New York, United States