Gene Expression and Biomarker Profiling of Keloid Skin

Study Overview
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Brief Summary
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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
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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

Official Title
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Gene Expression and Biomarker Profiling of Keloid Skin

Conditions
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Keloid, Keloid of Ear Lobe, Healthy Adults

Intervention / Treatment
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* Procedure: Biopsy and/or triamcinolone injection
* Procedure: Excisional Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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<br>* 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.<br>|
| Active Comparator: Group 2<br>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<br>* 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.<br>|
| Active Comparator: Group 3<br>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<br>* 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.<br>|
| Active Comparator: Group 4<br>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<br>* 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.<br>|
| Active Comparator: Group 5<br>Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids. | Procedure: Biopsy and/or triamcinolone injection<br>* 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.<br>|
| Other: Earlobe Keloid<br>Complete excision of an earlobe keloid measuring > 10mm will be taken. | Procedure: Excisional Biopsy<br>* Complete excision of an earlobe keloid will be taken.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keloid