Clinical trial

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

Name

Tacrolimus vs Hydrocortisone

Description

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.

Trial arms

Trial start

2022-05-15

Estimated PCD

2022-11-20

Trial end

2023-04-30

Status

Completed

Phase

Early phase I

Treatment

Tacrolimus

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

Arms:

Tacrolimus group

Other names:

Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.

Hydrocortisone

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

Arms:

Hydrocortisone group

Other names:

Hydrocortisone (Micort 1%®) was manufactured by Cid company for pharmaceutical and chemical industries, Egypt.

Size

200

Primary endpoint

evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA)

4 months

severity assessment

4 months

Eligibility criteria

Inclusion Criteria: * Male or female patients * 2-16 years old * diagnosed with Atopic Dermatitis according to Hanifin and Rajka criteria Exclusion Criteria: * patients with serious skin disorder other than Atopic Dermatitis * patients taking systemic corticosteroids or anti-inflammatory medications.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, double blinded, simply randomized clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '200 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

Updated at

2023-07-24

1 organization

1 product

1 drug

2 indications

Organization

Drug

Indication

Indication

Product