Burn ScarNCT04619589
Characterization of Dyschromic Hypertrophic Scar
An observational study of Burn Scar and Hypertrophic Scar, run by Medstar Health Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Scar, Hypertrophic Scar, Hyperpigmentation
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2019to 28 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects eligible for this study will have a dyschromic scar following thermal, chemical, or electrical trauma.
Who may be able to join
- 18 years of age or older
- Skin trauma resulting in a dyschromic scar
Who cannot join
- Dyschromic scar dole to face, genitals, fingers, or toes
- Known Lidocaine allergy
- Pregnancy
- Prisoner Status
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- Burn Scar, Hypertrophic Scar, Hyperpigmentation, Hypopigmented Scar
- Keywords
- burn, scar, hypertrophic scar, dyspigmentation, dyschromic scar
- Medical subject headings
- Cicatrix, Hypertrophic, Hyperpigmentation, Burns, Cicatrix
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
Characterize Pigmentation Signaling
Compare pigmentation signaling molecules between hyper-, hypo-, and normally pigmented scar and skin using immunofluorescent staining and gene expression analysis.
Measured: 1 year
Characterize melanin levels using non-invasive skin probes
Obtain average melanin index, fibrosis, and elastimeter values for subjects with dyschromic hypertrophic scar.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start21 May 2019
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Shupp, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619589
- Sponsor's protocol ID
- Study430
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2020
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Dyschromic Hypertrophic Scar: An Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT04619589
- Acronym / sponsor ID
- Study430
- Conditions
- Burn Scar, Hypertrophic Scar, Hyperpigmentation, Hypopigmented Scar
- Keywords
- burn, scar, hypertrophic scar, dyspigmentation, dyschromic scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects eligible for this study will have a dyschromic scar following thermal, chemical, or electrical trauma.
Key inclusion criteria (2 listed)
- 18 years of age or older
- Skin trauma resulting in a dyschromic scar
Key exclusion criteria (4 listed)
- Dyschromic scar dole to face, genitals, fingers, or toes
- Known Lidocaine allergy
- Pregnancy
- Prisoner Status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Characterize Pigmentation Signaling
Time frame: 1 year
Characterize melanin levels using non-invasive skin probes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Shupp, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Scar and Hypertrophic Scar, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Melanocyte Presence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.