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

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.

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Key information

Conditions

Dermatologic Disease Skin Diseases Skin and Connective Tissue Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus ointment

Drug

tacrolimus is an immunosuppressive drug acting as an immunomodulator to assist manage acute flares and reducing the severity of future flares

Hydrocortisone 1% cream

Drug

Topical corticosteroids (TCS) are the cornerstone for the management of AD to which other treatments are compared.

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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 7, 2022
Registry last updated: Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed