NCT04619589|Completed
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Sponsor study identifier
observational
50
1 country
1
Study Start
May 21, 2019
Actual (reported)Primary Completion
June 28, 2023
Actual (reported)Study Completion
June 28, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 28, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2019
Actual (reported)November 2, 2020
Actual (reported)November 6, 2020
Actual (reported)June 28, 2023
Actual (reported)June 28, 2023
Actual (reported)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
Characterize Pigmentation Signaling
1 year
Characterize melanin levels using non-invasive skin probes
1 year
Subjects eligible for this study will have a dyschromic scar following thermal, chemical, or electrical trauma.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Skin tissue and blood samples will be obtained. Blood and skin tissue will be coded with unique identifying numbers and maintained in our lab. Samples that are not completely used in this study may (with the permission of the subject via Informed Consent and HIPAA Authorization) be transferred to an existing Biospecimen Repository (MedStar IRB #2012- 233) and stored indefinitely. All biologic samples, as well as genomic data, are subject to withdrawal from their respective repositories at any time upon request of the research participant.
Jeffrey Shupp, MD
Medstar Health Research Institute
50 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2020
First Posted
November 6, 2020
Study Start
May 21, 2019
Actual (reported)Treatment of Hypertrophic Scars With Intradermal Botox
Contact the study team to confirm eligibility.
Primary Completion
June 28, 2023
Actual (reported)Study Completion
June 28, 2023
Actual (reported)Last Updated
November 3, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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