Characterization of Dyschromic Hypertrophic Scar

NCT04619589 | Completed

• 1 other identifier: Study430
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there are limited prevention or treatments available for dyschromia in burn hypertrophic scars (HTSs). The limited available techniques involve transferring melanocytes from unaffected areas to the scar to adjust pigment. These techniques involve the creation of a donor site and do not utilize the cells that may already be present in scars. This study aims to confirm melanocyte presence in regions of hypo- and hyper- pigmented HTS. If melanocytes can be found in regions of hypopigmentation, these scars may be able to be treated in the future by pigmentation stimulators without the need for surgery. Additionally, if pigmentation specific molecules of interest can be found to be up-regulated in hyperpigmented scar, these may be able to be altered by a pharmacotherapy.

Conditions

Burn Scar; Hypertrophic Scar; Hyperpigmentation; Hypopigmented Scar

Keywords

burn; scar; hypertrophic scar; dyspigmentation; dyschromic scar

Outcome Measures

Primary Outcomes (1)

• Identify Melanocyte Presence

  Confirm melanocyte presence in regions of hyper- and hypo-pigmented HTS, as well as normal skin by multiple assays including en face staining and immunofluorescent staining with melanocytes markers.

  1 year

Secondary Outcomes (2)

• Characterize Pigmentation Signaling

  1 year

• Characterize melanin levels using non-invasive skin probes

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects eligible for this study will have a dyschromic scar following thermal, chemical, or electrical trauma.

You may qualify if:

• years of age or older
• Skin trauma resulting in a dyschromic scar

You may not qualify if:

• Dyschromic scar dole to face, genitals, fingers, or toes
• Known Lidocaine allergy
• Pregnancy
• Prisoner Status

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin tissue and blood samples will be obtained. Blood and skin tissue will be coded with unique identifying numbers and maintained in our lab. Samples that are not completely used in this study may (with the permission of the subject via Informed Consent and HIPAA Authorization) be transferred to an existing Biospecimen Repository (MedStar IRB #2012- 233) and stored indefinitely. All biologic samples, as well as genomic data, are subject to withdrawal from their respective repositories at any time upon request of the research participant.

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Hyperpigmentation; Burns; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Jeffrey Shupp, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: May 21, 2019
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)