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Dermatological Abnormalities in Beta-thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894605
Recruitment Status : Unknown
Verified March 2019 by Neveen Mamdoh Farag, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Neveen Mamdoh Farag, Assiut University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Beta-Thalassemia Device: thalassemia

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 Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital
Estimated Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 2, 2021
Estimated Study Completion Date : April 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Intervention Details:
  • Device: thalassemia
    thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all patient examined by single dermatologist to record any dermatological abnormalities
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894605


Contacts
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Contact: Alsayed khalil Abd elkareem, Professor 01060805170 Khalilsay@gmail.com
Contact: Mostafa Mohamed, Lecturer 01006244311 Mustafa-embaby@aun.edu.eg

Sponsors and Collaborators
Assiut University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Neveen Mamdoh Farag, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03894605    
Other Study ID Numbers: DBTM
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn