Characterization of Dyschromic Hypertrophic Scar

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burn Scar Burns Cicatrix Cicatrix, Hypertrophic Fibrosis Hyperpigmentation Hypertrophic Scar Hypopigmented Scar Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MedStar Washington Hospital Center

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

About this study

Subjects with burn scars that are lighter and/or darker than their normal skin will be asked to participate in this study. It is being done to obtain more information about why some people develop scars that are different in color to their normal skin after trauma to the skin such as a burn.

Participants who wish to participate will have scar measured with a ruler, and study sites identified and photographed.

Additionally the following procedures will be done:

Non-invasive measurements: Each area of scar will have multiple non-invasive measurements done. These include:

scar scales - subjective measures of color, itching, pain, height, etc.
elasticity - a probe is briefly placed on top of the skin to measure its ability to stretch
induration - a probe is briefly placed on top of the skin to measure how firm it is
color - a skin probe in briefly placed on top of the skin to measure its color

Biopsies: Based on the measurement of the scars, several small 3mm punch biopsies will be done. Subjects with light colored scars and total scar greater than 500cm2 are eligible to participate in an optional sub-study. For this sub-study, an additional excisional biopsy 1 cm by 2 cm in the shape of an oval will be obtained from the lighter colored scar.

Blood collection: Blood will be collected for correlating blood characteristics to scar outcome. Approximately 20 mL of blood will be collected, which is less than 2 tablespoons. A portion of this blood might be used in the future for genome sequencing of pigmentation or hypertrophic scar-related gene sequences. Whole genome sequencing will not be performed.

Interview: Personal information, medical history, health behaviors, and scar history will be reviewed.

Data collection: Information about initial burn injury, hospitalization, and outpatient visits will be requested from the medical record.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Identify Melanocyte Presence

Time frame: 1 year

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.

Secondary outcomes

Characterize Pigmentation Signaling

Time frame: 1 year

Compare pigmentation signaling molecules between hyper-, hypo-, and normally pigmented scar and skin using immunofluorescent staining and gene expression analysis.
Characterize melanin levels using non-invasive skin probes

Time frame: 1 year

Obtain average melanin index, fibrosis, and elastimeter values for subjects with dyschromic hypertrophic scar.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Characterization of Dyschromic Hypertrophic Scar: An Observational Clinical Trial

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Nov 6, 2020
Registry last updated: Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed