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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05607901
Enrollment
100
Registered
2022-11-07
Start date
2022-10-28
Completion date
2023-11-20
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatologic Disease

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.

Interventions

DRUGTacrolimus ointment

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

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double-blinded

Intervention model description

• A randomized, controlled, and parallel study will comprise 100 patients with AD

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.4 monthsTo 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026