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

Allergan

Status: Completed

Conditions: Dermal Nodule

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03425721

CMO-US-FAS-0486

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 1 patient group

All Participants

Treatment:

Other: No Intervention