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 |
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.
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
West Hollywood, California 92269
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