A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone

Dermatologic Disease Clinical Trial

Official title:

A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone in Management of Atopic Dermatitis in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607901
• Other study ID #: 35928
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Dermatologic Disease
• Skin Diseases

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