Clinical trial

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

Name

35928

Description

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.

Trial arms

Trial start

2022-10-28

Estimated PCD

2025-06-20

Trial end

2025-08-20

Status

Recruiting

Phase

Early phase I

Treatment

Tacrolimus ointment

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

Arms:

Tacrolimus Group

Hydrocortisone 1% cream

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

Arms:

Hydrocortisone Group

Size

100

Primary endpoint

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

4 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '• A randomized, controlled, and parallel study will comprise 100 patients with AD', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blinded', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-01-30

1 organization

2 products

1 indication

Organization

Product

Indication

Product