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

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ClinicalTrials.gov Identifier: NCT03425721
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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

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Study Type : Observational
Estimated Enrollment : 10 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
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All Participants
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. This population will only include subjects who, before receiving the HA soft tissue filer were naïve to soft tissue fillers or had previously received only HA-based soft tissue fillers.
Other: No Intervention
No Intervention is administered in this study.




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.



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

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


Contacts
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Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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United States, California
Skin Care and Laser Physicians (SCLP) of Beverly Hills Recruiting
West Hollywood, California, United States, 92269
Contact: Study Coordinator    310-246-0495      
United States, New York
Assure Surgical, P.C. Recruiting
New York, New York, United States, 11598
Contact: Study Coordinator    516-295-0404      
Australia, New South Wales
Integrated Specialist Healthcare Active, not recruiting
Miranda, New South Wales, Australia, 2228
Australia, Victoria
Dermatology Insitute of Victoria Recruiting
South Yarra, Victoria, Australia, 3141
Contact: Study Coordinator    61 398264966      
Belgium
Aalst Dermatology Clinic Recruiting
Aalst, Belgium, 43-9300
Contact: Study Coordinator    325-378-1899      
Canada, British Columbia
Carruthers and Humphrey Cosmetic Medicine Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Ontario
Nowell Solish Withdrawn
Toronto, Ontario, Canada, M5R3N8
Germany
Klinik Für Dermatologie Und Allergologie Der Ruhr-Universität Bochum St. Josef Hospital Withdrawn
Bochum, Germany, D-44791
Hautzentrum Koeln Active, not recruiting
Cologne, Germany, 50996
Skin Concept Withdrawn
Muenchen, Germany, 80333
Italy
Servizio Ambulatoriale di Medicina Active, not recruiting
Rome, Italy, 00186
Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CA
Contact: Study Coordinator    3 11 070 40110      
South Africa
Knysna Advanced Medical Centre Recruiting
Knysna, South Africa, 6571
Contact: Study Coordinator    27 11 356 6206      
Sponsors and Collaborators
Allergan
Investigators
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Study Director: John Maltman Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03425721     History of Changes
Other Study ID Numbers: CMO-US-FAS-0486
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents