- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894605
Dermatological Abnormalities in Beta-thalassemia Major
March 27, 2019 updated by: Neveen Mamdoh Farag, Assiut University
Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital
to study the frequency and pattern of dermatological abnormalities in egyptian childern with beta thalassemia.relationof
abnormalities to duration of disease and frequency of transfusion
Study Overview
Detailed Description
thalassemia refers to agroup of inherited disease characterized by decreased or absent synthesis of normal globin .skinvdisorders
are usually neglected and frequently underdiagnosed among these patients.skin
disease specially pruritus and xerosis are observed highly frequently in patients with beta-thalassemia.pityriasis
alba is arelatively common skin disorder.the
trophic skin changes and leg ulcers occurred after the age of 15 years
Study Type
Observational
Enrollment (Anticipated)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alsayed khalil Abd elkareem, Professor
- Phone Number: 01060805170
- Email: Khalilsay@gmail.com
Study Contact Backup
- Name: Mostafa Mohamed, Lecturer
- Phone Number: 01006244311
- Email: Mustafa-embaby@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patient examined by single dermatologist to record any dermatological abnormalities
Description
Inclusio2n Criteria:
- clinical diagnosis of dermatological abnormalities in thalassemic patient. must be on chelator
Exclusion Criteria:
- patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities
Time Frame: one month
|
the number of patients who develop any dermatological disorder as a result of iron overload after frequent blood transfusion
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed.
- El-Dash H, Adel S. Cutaneous manifestations in Egyptian children with beta-thalassemia major: Relationship with serum ferritin, thyroid profile, and treatment modalities. Pediatr Dermatol. 2018 Sep;35(5):639-643. doi: 10.1111/pde.13570. Epub 2018 Jun 26.
- Dogramaci AC, Savas N, Ozer B, Duran N. Skin diseases in patients with beta-thalassemia major. Int J Dermatol. 2009 Oct;48(10):1057-61. doi: 10.1111/j.1365-4632.2009.04176.x.
- CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 2, 2020
Primary Completion (Anticipated)
March 2, 2021
Study Completion (Anticipated)
April 2, 2021
Study Registration Dates
First Submitted
March 22, 2019
First Submitted That Met QC Criteria
March 27, 2019
First Posted (Actual)
March 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBTM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Beta-Thalassemia
-
M.D. Anderson Cancer CenterWithdrawnSickle Cell Disease | Sickle Beta Thalassemia | Beta Thalassemia Major | Sickle Cell-SS Disease | Sickle Beta 0 Thalassemia | Sickle Beta Plus ThalassemiaUnited States
-
CelgeneTerminatedBeta Thalassemia Intermedia | Beta Thalassemia MajorFrance, United Kingdom, Italy, Greece
-
University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
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Editas Medicine, Inc.RecruitingHemoglobinopathies | Thalassemia Major | Thalassemia Intermedia | Transfusion Dependent Beta ThalassemiaUnited States, Canada
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Ionis Pharmaceuticals, Inc.TerminatedBeta Thalassemia IntermediaAustralia, Thailand, Greece, Lebanon, Turkey
-
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-
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-
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