- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00008502
Genetic Analysis of Familial Keloids
The purpose of this study is to identify the gene or genes responsible for keloid formation. Keloids are raised scars on the skin that form after a minor injury. A tendency to develop keloids often runs in families, suggesting a possible genetic basis.
People who have had a classic (butterfly-shaped or wound-overflowing) keloid for at least one year may be eligible for this study. In addition to these probands (original participants), family members over 12 years of age who have either classic or non-classic keloids and those 18 years of age or older without keloids may participate.
Probands and family members with keloids will have a medical history focusing on skin problems-particularly keloids-and a skin examination. In some cases, with the subject s permission, photos of the keloids will be taken. All participants will have 35 milliliters (about 2 tablespoons) of blood drawn for DNA (genetic) testing and for measurement of blood proteins, including cytokines, which can affect other tissues and cause scarring. Part of the blood sample will be used for additional genetic studies unrelated to keloids. The samples will be coded for confidentiality.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
- Proband: must have a butterfly-shaped or wound-overflowing keloid, present for at least one year (this description represents classic keloid, and avoids hypertrophic scar)
- Affected family members: all family members of the proband who have either classic keloids, as described above, or non-classic keloids, such as ball shaped-keloids on the ear.
- Unaffected family members: all family members who lack keloids.
- Impaired subjects for whom a legal guardian provides consent.
- Pregnant women.
EXCLSUION CIRTERIA:
- Subjects who are unwilling or unable to give informed consent or assent.
- Impaired individuals from whom it not possible to obtained parental consent (minors) or guardian consent (adults).
- Keloid patients who have <3 relatives with keoids.
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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18 years of age or older
without keloids
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family members over 12 years of age
who have either classic or non-classic keloids
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Probands
original participants who have had a classic (butterfly-shaped or wound-overflowing) keloidfor at least one year
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Finding a genetic locus
Time Frame: 12/01/2018
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The purpose of this study is to identify the gene or genes responsible for keloid formation
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12/01/2018
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010062
- 01-DK-0062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keloid
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CHA UniversityCompletedHypertrophic or Keloid ScarsKorea, Republic of
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Queen Mary University of LondonWithdrawn
-
SolitonEmergent Clinical Consulting, LLCCompleted
-
Sensus HealthcareUnknownKeloid ScarUnited States
-
Sensus HealthcareUnknown
-
University of UlmCompleted
-
NYU Langone HealthCompleted
-
Northwestern UniversityCompleted
-
Our Lady of the Lake HospitalLouisiana State University Health Sciences Center in New OrleansCompletedPost-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of KeloidsKeloid | Keloid Scar Following SurgeryUnited States
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Next Science TMJacksonville Center For Clinical ResearchWithdrawnKeloid Scar Following SurgeryUnited States