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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05607901
Other study ID # 35928
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 28, 2022
Est. completion date August 20, 2025

Study information

Verified date January 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

One of the most frequent skin conditions is atopic dermatitis (AD), characterized by its pruritic inflammation effect. Where the prevalence of AD increased in the last three decades by two or three folds worldwide, especially in developed countries, AD is supposed to affect about 15% to 30% of children, and 2% to 10% of adults. This type of dermatitis is frequently linked to a family history of other atopic illnesses such as allergic rhinitis or asthma.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 20, 2025
Est. primary completion date June 20, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria: - Male or female, 2-16 years old AD patients. Exclusion Criteria: - patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tacrolimus ointment
tacrolimus is an immunosuppressive drug acting as an immunomodulator to assist manage acute flares and reducing the severity of future flares
Hydrocortisone 1% cream
Topical corticosteroids (TCS) are the cornerstone for the management of AD to which other treatments are compared.

Locations

Country Name City State
Egypt Tanta Unuversity Tanta

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood. To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10. 4 months
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