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

Study Identifier
CMO-US-FAS-0486
CT.gov Identifier
NCT03425721
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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 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

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Skin Care and Laser Physicians (SCLP) of Beverly Hills
    West Hollywood, California, United States, 92269
    Status
    Not applicable
    Location
    Assure Surgical, P.C.
    New York, New York, United States, 11598
    Status
    Not applicable