Dermatological Abnormalities in Beta-thalassemia Major

• ClinicalTrials.gov Identifier: NCT03894605
• Recruitment Status: Unknown
• First Posted: March 28, 2019
• Last Update Posted: March 28, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Neveen Mamdoh Farag, Assiut University

Tracking Information

• First Submitted Date: March 22, 2019
• First Posted Date: March 28, 2019
• Last Update Posted Date: March 28, 2019
• Estimated Study Start Date: March 2, 2020
• Estimated Primary Completion Date: March 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dermatological Abnormalities in Beta-thalassemia Major
• Official Title: Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital
• 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
• 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
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: all patient examined by single dermatologist to record any dermatological abnormalities
• Condition: Beta-Thalassemia

Intervention

Device: thalassemia

thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion

• Study Groups/Cohorts: Not Provided

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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 27, 2019): 125
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2, 2021
• Estimated Primary Completion Date: March 2, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03894605
• Other Study ID Numbers: DBTM
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Neveen Mamdoh Farag, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: March 2019