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Tacrolimus Versus Hydrocortisone in Atopic Dermatitis

NCT05324618 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-07-24

No results posted yet for this study

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.

Conditions

  • Atopic
  • Dermatitis

Interventions

DRUG

Tacrolimus

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

DRUG

Hydrocortisone

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

Sponsors & Collaborators

  • National Hepatology & Tropical Medicine Research Institute

    collaborator OTHER_GOV

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Amal A. Mohamed · Department of Biochemistry, National Hepatology and Tropical Medicine Research institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2022-11-20
Completion
2023-04-30

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05324618 on ClinicalTrials.gov