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NCT03894605 Clinical Trial

Dermatological Abnormalities in Beta-thalassemia Major

Beta-Thalassemia Clinical Trial

Official title:
Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03894605
Other study ID # DBTM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date April 2, 2021

Study information
Verified date March 2019
Source Assiut University
Contact Alsayed khalil Abd elkareem, Professor
Phone 01060805170
Email Khalilsay@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 125
Est. completion date April 2, 2021
Est. primary completion date March 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• thalassemia
thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed. Review. — View Citation

CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities the number of patients who develop any dermatological disorder as a result of iron overload after frequent blood transfusion one month
See also
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Recruiting NCT04143724 - Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia Phase 2
Terminated NCT03381833 - A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia Phase 2
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Not yet recruiting NCT01996683 - Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml) N/A
Active, not recruiting NCT01016093 - Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients Phase 2/Phase 3
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