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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Dermatologic Disease

Treatments: Drug: Tacrolimus ointment; Drug: Hydrocortisone 1% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05607901

35928

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Tacrolimus Group

Active Comparator group

Description:

50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.

Treatment:

Drug: Tacrolimus ointment

Hydrocortisone Group

Active Comparator group

Description:

50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.

Treatment:

Drug: Hydrocortisone 1% cream