Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04619589 |
| Other study ID # |
Study430 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2019 |
| Est. completion date |
June 28, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Medstar Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
