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

Tanta University1 site in 1 country100 target enrollmentOctober 28, 2022

ConditionsDermatologic Disease

InterventionsTacrolimus ointment Hydrocortisone 1% cream

DrugsTacrolimus ointment Hydrocortisone 1% cream

Overview

Phase: Phase 2
Intervention: Tacrolimus ointment
Conditions: Dermatologic Disease
Sponsor: Tanta University
Enrollment: 100
Locations: 1
Primary Endpoint: To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 28, 2022

End Date

November 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tanta University

Responsible Party

Principal Investigator

Mostafa Bahaa

Teaching Assistant

Tanta University

Eligibility Criteria

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.

Arms & Interventions

Tacrolimus Group

50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.

Intervention: Tacrolimus ointment

Hydrocortisone Group

50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.

Intervention: Hydrocortisone 1% cream

Outcomes

Primary Outcomes

To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.

Time Frame: 4 months

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.