Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Completed
Conditions studied: Dermal Nodule
In brief
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.
Key facts
- Study ID
- NCT03425721
- Run by
- Allergan
- People needed
- 17
- Starts
- 2017-11-21
- Expected to finish
- 2021-04-13
- Last updated by the study team
- 2021-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Skin Care and Laser Physicians (SCLP) of Beverly Hills — West Hollywood, California, United States
- Assure Surgical, P.C. — New York, New York, United States
Full record on ClinicalTrials.gov
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