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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03425721




Registration number
NCT03425721
Ethics application status
Date submitted
19/01/2018
Date registered
8/02/2018
Date last updated
5/06/2019

Titles & IDs
Public title
Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Scientific title
Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Secondary ID [1] 0 0
CMO-US-FAS-0486
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermal Nodule 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No Intervention

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 interventions: No Intervention
No Intervention is administered in this study.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Histological Sampling - 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.
Timepoint [1] 0 0
12 Weeks
Primary outcome [2] 0 0
Microbiological Sampling - Microbiology lab assessment of biopsy sample for analysis of the presence and species of bacteria/mycobacteria within the biopsy.
Timepoint [2] 0 0
12 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Integrated Specialist Healthcare - Miranda
Recruitment hospital [2] 0 0
Dermatology Insitute of Victoria - South Yarra
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Germany
State/province [6] 0 0
Bochum
Country [7] 0 0
Germany
State/province [7] 0 0
Cologne
Country [8] 0 0
Germany
State/province [8] 0 0
Muenchen
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Netherlands
State/province [10] 0 0
Rotterdam
Country [11] 0 0
South Africa
State/province [11] 0 0
Knysna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03425721
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Maltman
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Registry Team
Address 0 0
Country 0 0
Phone 0 0
877-277-8566
Fax 0 0
Email 0 0
IR-CTRegistration@Allergan.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03425721