NCT03425721

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

3.4 years

First QC Date

January 19, 2018

Last Update Submit

July 30, 2021

Conditions

Dermal Nodule

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 Weeks

  • Microbiological Sampling

    Microbiology lab assessment of biopsy sample for analysis of the presence and species of bacteria/mycobacteria within the biopsy.

    12 Weeks

Study Arms (1)

All Participants

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention is administered in this study.

All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skin Care and Laser Physicians (SCLP) of Beverly Hills

West Hollywood, California, 92269, United States

Location

Assure Surgical, P.C.

New York, New York, 11598, United States

Location

Related Links

Study Officials

  • ALLERGAN INC.

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 8, 2018

Study Start

November 21, 2017

Primary Completion

April 13, 2021

Study Completion

April 13, 2021

Last Updated

August 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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.
More information

Locations

US(2)