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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03425721
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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 histological response.

Condition or disease Intervention/treatment
Dermal Nodule Other: No Intervention

Study Design
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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : April 13, 2021
Actual Study Completion Date : April 13, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
All Participants Other: No Intervention
No Intervention is administered in this study.


Outcome Measures
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Primary Outcome Measures :
  1. Histological Sampling [ Time Frame: 12 Weeks ]
    Histological lab assessment of biopsy sample for analysis of Hematoxylin and eosin (H&E), orcein, periodic acid-Schiff, gram stain and immunohistochemistry (IHC), with a histopathology assessment to identify possible presence and location of bacteria, mycobacteria, fungus, mold, and/or yeast and the immune/inflammation response within the biopsy.

  2. Microbiological Sampling [ Time Frame: 12 Weeks ]
    Microbiology lab assessment of biopsy sample for analysis of the presence and species of bacteria/mycobacteria within the biopsy.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425721


Locations
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United States, California
Skin Care and Laser Physicians (SCLP) of Beverly Hills
West Hollywood, California, United States, 92269
United States, New York
Assure Surgical, P.C.
New York, New York, United States, 11598
Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
More Information
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Additional Information:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03425721    
Other Study ID Numbers: CMO-US-FAS-0486
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: For details on when studies are available for sharing, please refer to the link below
Access Criteria: 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.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No