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

Subjects who present with late occurring nodules, occurring more than 4 weeks but less than 2 years after the latest injection of any HA soft tissue filler.

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

For details on when studies are available for sharing, please refer to the link below

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.