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

Histological and Microbiological Evaluation of Late Occurring Nodules with Hyaluronic Acid Dermal Fillers - Allergan; 0260/0144; CMO-US-FAS-0486

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50302

Enrollment

Registered

2018-02-01

Start date

2019-07-04

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bump Nodule

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 but

Exclusion criteria

Exclusion criteria: • Have ever 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 a history of keloid or hypertrophic scarring; • Are pregnant; and • For subjects with a nodule: Have received intralesional intervention for the nodule (e.g. hyaluronidase, corticosteroids, antibiotics, 5-fluorouracil);

Design outcomes

Primary

Measure	Time frame
Study Variables Data collection: For all subjects: • Questionnaire: Subject medical history and potential predisposing conditions; • Hematology: Blood analysis and serum storage; Additionally for subjects with a nodule: • Picture(s) of the nodule If the subject agrees to the biopsy: • Histology: Hematoxylin and eosin (H&E), orcein, periodic acid-Schiff, gram stain and immunohistochemistry (IHC), with a histopathology assessment to identify presence and location of bacteria, mycobacteria, fungus, mold, and/or yeast and the immune/inflammation response within the biopsy; • Microbiology: Analysis of the presence and species of bacteria/mycobacteria within the biopsy; and • Questionnaire and medical record review (at approximately 12 weeks follow-up): Treatment and outcome of treatment for late occurring nodule.	—

Measure

Time frame

Study Variables Data collection: For all subjects: • Questionnaire: Subject medical history and potential predisposing conditions; • Hematology: Blood analysis and serum storage; Additionally for subjects with a nodule: • Picture(s) of the nodule If the subject agrees to the biopsy: • Histology: Hematoxylin and eosin (H&E), orcein, periodic acid-Schiff, gram stain and immunohistochemistry (IHC), with a histopathology assessment to identify presence and location of bacteria, mycobacteria, fungus, mold, and/or yeast and the immune/inflammation response within the biopsy; • Microbiology: Analysis of the presence and species of bacteria/mycobacteria within the biopsy; and • Questionnaire and medical record review (at approximately 12 weeks follow-up): Treatment and outcome of treatment for late occurring nodule.

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Countries

Netherlands

Outcome results