Clinical trial NCT04619589: Characterization of Dyschromic Hypertrophic Scar
Official title: Characterization of Dyschromic Hypertrophic Scar: An Observational Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Scar
Hypertrophic Scar
Hyperpigmentation
Hypopigmented Scar
Keywords: burn
scar
hypertrophic scar
dyspigmentation
dyschromic scar
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects eligible for this study will have a dyschromic scar following thermal, chemical, or electrical trauma.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify Melanocyte Presence
timeFrame: 1 year
Secondary outcomes:
measure: Characterize Pigmentation Signaling
timeFrame: 1 year
measure: Characterize melanin levels using non-invasive skin probes
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Jeffrey Shupp, MD
role: PRINCIPAL_INVESTIGATOR
References: