Dermal NoduleNCT03425721
Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
An observational study of Dermal Nodule, run by Allergan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermal Nodule
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2017to 13 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Assure Surgical, P.C.
New York, New York, 11598
Skin Care and Laser Physicians (SCLP) of Beverly Hills
West Hollywood, California, 92269
About this study
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.
- Conditions
- Dermal Nodule
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention is administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Microbiological Sampling
Microbiology lab assessment of biopsy sample for analysis of the presence and species of bacteria/mycobacteria within the biopsy.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start21 Nov 2017
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425721
- Sponsor's protocol ID
- CMO-US-FAS-0486
- Status last verified
- Jul 2021
- First submitted
- 19 Jan 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
- ClinicalTrials.gov ID
- NCT03425721
- Acronym / sponsor ID
- CMO-US-FAS-0486
- Conditions
- Dermal Nodule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention is administered in this study. | Other | All Participants |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Dermal Nodule
RecruitingObservational study
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermal Nodule, run by Allergan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological Sampling (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.