Status:
COMPLETED
Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Lead Sponsor:
Allergan
Conditions:
Dermal Nodule
Eligibility:
All Genders
18+ years
Brief 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 histolo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03425721
Start Date
November 21 2017
End Date
April 13 2021
Last Update
August 6 2021
Active Locations (2)
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1
Skin Care and Laser Physicians (SCLP) of Beverly Hills
West Hollywood, California, United States, 92269
2
Assure Surgical, P.C.
New York, New York, United States, 11598