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

NCT05607901 | Completed Phase 2

• 1 other identifier: 35928
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10.

  4 months

Study Arms (2)

Tacrolimus Group

ACTIVE COMPARATOR

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

Drug: Tacrolimus ointment

Hydrocortisone Group

ACTIVE COMPARATOR

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

Drug: Hydrocortisone 1% cream

Interventions

Tacrolimus ointment DRUG

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

Tacrolimus Group

Hydrocortisone 1% cream DRUG

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

Hydrocortisone Group

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, 2-16 years old AD patients.

You may not qualify if:

• patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39114823 DERIVED

MeSH Terms

Conditions

Skin Diseases

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: • A randomized, controlled, and parallel study will comprise 100 patients with AD

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 7, 2022
• Study Start: October 28, 2022
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

EG (1)