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

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05607901
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.7
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatologic Disease	Drug: Tacrolimus ointment; Drug: Hydrocortisone 1% cream	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: • A randomized, controlled, and parallel study will comprise 100 patients with AD• A randomized, controlled, and parallel study will comprise 100 patients with AD
• Masking: Double (Participant, Investigator)
• Masking Description: double-blinded
• Primary Purpose: Treatment
• Official Title: A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone in Management of Atopic Dermatitis in Children
• Actual Study Start Date: Oct 28, 2022
• Anticipated Primary Completion Date: Jun 20, 2025
• Anticipated Study Completion Date: Aug 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Tacrolimus ointment; tacrolimus is an immunosuppressive drug acting as an immunomodulator to assist manage acute flares and reducing the severity of future flares
Active Comparator: Hydrocortisone Group 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; Topical corticosteroids (TCS) are the cornerstone for the management of AD to which other treatments are compared.

Outcome Measures

Primary Outcome Measures

1. To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood. [4 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta Unuversity	Tanta		Egypt	31527

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mostafa Bahaa, Teaching Assistant, Tanta University
• ClinicalTrials.gov Identifier: NCT05607901
• Other Study ID Numbers: 35928
• First Posted: Nov 7, 2022
• Last Update Posted: Nov 7, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Diseases; Hydrocortisone; Tacrolimus

Study Results

No Results Posted as of Nov 7, 2022