CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Tacrolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05324618
NCT05324618Phase 4Completed

A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis

Ain Shams University·interventional·Posted Apr 12, 2022·Updated Jul 24, 2023

In Brief

A Phase 4 clinical trial evaluating Tacrolimus and Hydrocortisone for Atopic and Dermatitis. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Atopic dermatitis (AD) is a very common inflammatory, genetic skin disorder that occurs more frequently in children. Its exact etiology is not known but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Corticosteroids are the first line and the mainstay therapy in management of atopic dermatitis but have many local and systemic adverse effects. The study aims to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in management of children diagnosed with atopic dermatitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic, Dermatitis
CountriesEgypt

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedApr 12, 2022
Enrollment StartMay 15, 2022
Primary CompletionNov 20, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.2 years ago

Interventions

Tacrolimusdrug

0.03% topical tacrolimus ointment applied on the affected areas twice daily for 4 months.

Hydrocortisonedrug

1% hydrocortisone cream applied on the affected areas twice daily for 4 months.