Gene Expression and Biomarker Profiling of Keloid Skin | NCT03228693 | Trialant

Gene Expression and Biomarker Profiling of Keloid Skin | NCT03228693 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biopsy and/or triamcinolone injection	Procedure	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.

Outcomes Module

Primary Outcomes

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

Contacts/Locations Module

Condition Browse Module