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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 21, 2017
End Date:January 1, 2020
Contact:Clinical Trial Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:877-277-8566

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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.


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
We found this trial at
3
sites
9201 Sunset Boulevard
West Hollywood, California 92269
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Miranda, New South Wales
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Miranda,
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New York, New York 11598
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New York, NY
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