Gene Expression and Biomarker Profiling of Keloid Skin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03228693

Enrollment

Registered

2017-07-25

Start date

2017-09-11

Completion date

2023-01-31

Last updated

2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid, Keloid of Ear Lobe, Healthy Adults

Keywords

Keloid

Brief 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. Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity 3. Biomarker analysis will provide useful insights for future targeted therapies for keloid scars

Detailed description

Objectives: 1. Determine gene expression profiles of keloid scar tissue using samples collected longitudinally 2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects

Interventions

PROCEDUREBiopsy and/or triamcinolone injection

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.

PROCEDUREExcisional Biopsy

Complete excision of an earlobe keloid will be taken.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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)

Exclusion criteria

* Patients who have had treatment of their keloid scar within 6 months of date of enrollment

Design outcomes

Primary

Measure	Time frame	Description
Keloid progression	One year	Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)
Gene Expression	One year	Blood will be drawn during first study visit for analysis
Keloid recurrence	One year	Assess keloid recurrence at biopsy site (measured by number of keloids)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026