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

NCT ID: NCT05607901

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2023-11-20

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.

Conditions

Dermatologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tacrolimus Group

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

Group Type: ACTIVE_COMPARATOR

Tacrolimus ointment

Intervention Type: DRUG

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

Hydrocortisone Group

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

Group Type: ACTIVE_COMPARATOR

Hydrocortisone 1% cream

Intervention Type: DRUG

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

Interventions

Tacrolimus ointment

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

Intervention Type: DRUG

Hydrocortisone 1% cream

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Teaching Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta Unuversity

Tanta, , Egypt

Countries

Egypt

References

Binsaleh AY, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El-Khateeb E, Kamal M, El-Samongy MA, Hamouda AO, Alghamdi AM, Alrubia S, Salahuddin MM, Eltantawy N. A randomized controlled trial comparing tacrolimus versus hydrocortisone for the treatment of atopic dermatitis in children: new perspectives on interferon gamma-induced protein and growth-related oncogene-alpha. Front Med (Lausanne). 2024 Jul 24;11:1399305. doi: 10.3389/fmed.2024.1399305. eCollection 2024.

Reference Type: DERIVED

PMID: 39114823 (View on PubMed)

Other Identifiers

35928

Identifier Type: -

Identifier Source: org_study_id