NCT03228693

Brief Summary

This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation. Hypothesis:

  1. 1.Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids
  2. 2.Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity
  3. 3.Biomarker analysis will provide useful insights for future targeted therapies for keloid scars

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

July 20, 2017

Last Update Submit

March 28, 2023

Conditions

KeloidKeloid of Ear LobeHealthy Adults

Keywords

Keloid

Outcome Measures

Primary Outcomes (3)

  • Keloid progression

    Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)

    One year

  • Gene Expression

    Blood will be drawn during first study visit for analysis

    One year

  • Keloid recurrence

    Assess keloid recurrence at biopsy site (measured by number of keloids)

    One year

Study Arms (6)

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.

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

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.

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.

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.

Procedure: Biopsy and/or triamcinolone injection

Earlobe Keloid

OTHER

Complete excision of an earlobe keloid measuring \> 10mm will be taken.

Procedure: Excisional Biopsy

Interventions

Biopsy and/or triamcinolone injectionPROCEDURE

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.

Group 1Group 2Group 3Group 4Group 5
Excisional BiopsyPROCEDURE

Complete excision of an earlobe keloid will be taken.

Earlobe Keloid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roopal Kundu, M.D.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Dermatology and Medical Education

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 25, 2017

Study Start

September 11, 2017

Primary Completion

September 2, 2021

Study Completion

January 31, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

US(1)