Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03425721
Ethics application status
Date submitted
19/01/2018
Date registered
8/02/2018
Date last updated
6/08/2021

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 -


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
Timepoint [1] 0 0
12 Weeks
Primary outcome [2] 0 0
Microbiological Sampling
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2021
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
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

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ALLERGAN INC.
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03425721