KeloidNCT03228693
Gene Expression and Biomarker Profiling of Keloid Skin
A study testing Biopsy and/or triamcinolone injection and Excisional Biopsy in people with Keloid and Keloid of Ear Lobe, run by Northwestern University at 1 site in United States.
Trial summary
This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation. Hypothesis: 1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keloid, Keloid of Ear Lobe, Healthy Adults
- What is being tested?
- Biopsy and/or triamcinolone injection and Excisional Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 31 Jan 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment
- Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)
Who cannot join
- Patients who have had treatment of their keloid scar within 6 months of date of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611
About this study
This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation.
Hypothesis:
- Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids
- Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity
- Biomarker analysis will provide useful insights for future targeted therapies for keloid scars
Read the detailed description
Objectives:
- Determine gene expression profiles of keloid scar tissue using samples collected longitudinally
- Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects
- Conditions
- Keloid, Keloid of Ear Lobe, Healthy Adults
- Being tested
- Biopsy and/or triamcinolone injection, Excisional Biopsy
- Keywords
- Keloid
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy and/or triamcinolone injectionProcedure or surgery
Subjects will have their blood drawn during the first study visit. Subsequently, a punch biopsy and/or triamcinolone injection will be given based on group timeline.
Excisional BiopsyProcedure or surgery
Complete excision of an earlobe keloid will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Baseline lesional and non-lesional biopsies and re-biopsy 6-8 weeks later with intralesional triamcinolone injections at 9-10, 12-16, and 24-32 weeks. Receives: Procedure: Biopsy and/or triamcinolone injection |
| Group 2 | Active comparator | Baseline lesional biopsy and re-biopsy at 6-8 weeks with intralesional triamcinolone injections at 3-4, 9-10, 12-16, and 24-32 weeks Receives: Procedure: Biopsy and/or triamcinolone injection |
| Group 3 | Active comparator | Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks. Receives: Procedure: Biopsy and/or triamcinolone injection |
| Group 4 | Active comparator | Baseline lesional biopsy and re-biopsy at 3-4 months with intralesional triamcinolone injections at 3-4, 6-8, 18-20 and 24-32 weeks. Receives: Procedure: Biopsy and/or triamcinolone injection |
| Group 5 | Active comparator | Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids. Receives: Procedure: Biopsy and/or triamcinolone injection |
| Earlobe Keloid | Other | Complete excision of an earlobe keloid measuring > 10mm will be taken. Receives: Procedure: Excisional Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keloid progression
Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)
Measured: One year
Gene Expression
Blood will be drawn during first study visit for analysis
Measured: One year
Keloid recurrence
Assess keloid recurrence at biopsy site (measured by number of keloids)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start11 Sep 2017
- Primary completion2 Sep 2021
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Roopal Kundu, Northwestern University
- Investigators
- Roopal Kundu, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228693
- Sponsor's protocol ID
- RVK 09062016
- Status last verified
- Mar 2023
- First submitted
- 20 Jul 2017
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression and Biomarker Profiling of Keloid Skin
- ClinicalTrials.gov ID
- NCT03228693
- Acronym / sponsor ID
- RVK 09062016
- Conditions
- Keloid, Keloid of Ear Lobe, Healthy Adults
- Keywords
- Keloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 25 Jul 2017 (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 aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation.
Hypothesis:
- Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids
- Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity
- Biomarker analysis will provide useful insights for future targeted therapies for keloid scars
Detailed description
Objectives:
- Determine gene expression profiles of keloid scar tissue using samples collected longitudinally
- Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Biopsy and/or triamcinolone injectionBaseline lesional and non-lesional biopsies and re-biopsy 6-8 weeks later with intralesional triamcinolone injections at 9-10, 12-16, and 24-32 weeks. |
| Group 2 | Active comparator | Procedure: Biopsy and/or triamcinolone injectionBaseline lesional biopsy and re-biopsy at 6-8 weeks with intralesional triamcinolone injections at 3-4, 9-10, 12-16, and 24-32 weeks |
| Group 3 | Active comparator | Procedure: Biopsy and/or triamcinolone injectionBaseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks. |
| Group 4 | Active comparator | Procedure: Biopsy and/or triamcinolone injectionBaseline lesional biopsy and re-biopsy at 3-4 months with intralesional triamcinolone injections at 3-4, 6-8, 18-20 and 24-32 weeks. |
| Group 5 | Active comparator | Procedure: Biopsy and/or triamcinolone injectionNormal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids. |
| Earlobe Keloid | Other | Procedure: Excisional BiopsyComplete excision of an earlobe keloid measuring > 10mm will be taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment
- Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)
Key exclusion criteria (1 listed)
- Patients who have had treatment of their keloid scar within 6 months of date of enrollment
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 |
|---|---|---|
| Biopsy and/or triamcinolone injectionSubjects will have their blood drawn during the first study visit. Subsequently, a punch biopsy and/or triamcinolone injection will be given based on group timeline. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4, Group 5 |
| Excisional BiopsyComplete excision of an earlobe keloid will be taken. | Procedure or surgery | Earlobe Keloid |
Primary outcome
Keloid progression
Time frame: One year
Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)
Gene Expression
Time frame: One year
Blood will be drawn during first study visit for analysis
Keloid recurrence
Time frame: One year
Assess keloid recurrence at biopsy site (measured by number of keloids)
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 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Keloid
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Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
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Radiotherapy for Keloids
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siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
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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.
Roopal Kundu, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and/or triamcinolone injection and Excisional Biopsy in people with Keloid and Keloid of Ear Lobe, run by Northwestern University at 1 site 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 1 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Keloid progression (time frame: One year). The study lists 3 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 29 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.