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

Completed

Conditions: Nodule
bump
10004018
10014982

Registration Number: NL-OMON50302

Lead Sponsor: Allergan (North America)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

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 < 2 years after the most recent HA filler
treatment and is determined to be greater than 3 mm in diameter by palpation;
• Agree to complete all study required procedures and follow-up; and
• Provide written informed consent to participate.
OR
• Have received HA fillers more than once, with the first filler procedure at
least two years prior to enrollment;
• Never developed a nodule;
• Agree to complete all study required procedures; and
• Provide written informed consent to participate.

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);

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures