Characterization of Dyschromic Hypertrophic Scar

Characterization of Dyschromic Hypertrophic Scar: An Observational Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Burn Scar; Hyperpigmentation; Hypertrophic Scar; Hypopigmented Scar

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

• Study Contact: Name: Bonnie C. Carney, PhD; Phone Number: (202) 877-2962; Email: bonnie.c.carney@medstar.net
• Study Contact Backup: Name: Research Program Manager; Phone Number: (301) 997-5242

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize Pigmentation Signaling	Compare pigmentation signaling molecules between hyper-, hypo-, and normally pigmented scar and skin using immunofluorescent staining and gene expression analysis.	1 year
Characterize melanin levels using non-invasive skin probes	Obtain average melanin index, fibrosis, and elastimeter values for subjects with dyschromic hypertrophic scar.	1 year

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Jeffrey Shupp, MD, MedStar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: scar; hypertrophic scar; burn; dyspigmentation; dyschromic scar
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pathological Conditions, Anatomical; Fibrosis; Pigmentation Disorders; Hypertrophy; Cicatrix; Hyperpigmentation; Cicatrix, Hypertrophic
• Other Study ID Numbers: Study430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No