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Tacrolimus Versus Hydrocortisone in Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05324618
Recruitment Status : Recruiting
First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Collaborator:
National Hepatology & Tropical Medicine Research Institute
Information provided by (Responsible Party):
Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tacrolimus Drug: Hydrocortisone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, double blinded, simply randomized clinical trial
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis
Estimated Study Start Date : April 15, 2022
Estimated Primary Completion Date : May 20, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Active Comparator: Tacrolimus group
100 patients treated by thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.
Drug: Tacrolimus
0.03% topical tacrolimus ointment applied on the affected areas twice daily for 4 months.
Other Name: Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.

Active Comparator: Hydrocortisone group
100 patients treated by thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.
Drug: Hydrocortisone
1% hydrocortisone cream applied on the affected areas twice daily for 4 months.
Other Name: Hydrocortisone (Micort 1%®) was manufactured by Cid company for pharmaceutical and chemical industries, Egypt.




Primary Outcome Measures :
  1. 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) [ Time Frame: 4 months ]
    estimation of the serum level of inflammatory cytokines (biochemical evaluation of IL-10 (pg/ml), IL-17 (pg/ml), IL-23 (pg/ml) using enzyme linked immunosorbent assay technique (ELISA)

  2. severity assessment [ Time Frame: 4 months ]
    Estimation of the effect on the dermatitis severity scale using the modified Eczema Area and Severity Index (mEASI) score. It is a tool used to evaluate the severity of eczema based on body surface area affected by lesions, morphology of lesions (erythema, papules, excoriation, and lichenification), severity of lesions (0-3), and pruritus. The scores range from 0 to 72 for the main symptoms of AD and from 0 to 18 for pruritus, giving a maximum possible score of 0 (no involvement) to 90 (maximum involvement), (0-0.9 clear, 1-8.9 mild, 9.0-29.9 moderate, 30.0-90 severe).


Secondary Outcome Measures :
  1. evaluate the tacrolimus safety [ Time Frame: 4 months ]
    assessment of treatment related toxicities; assessment of the incidence rate of burning

  2. evaluation of tacrolimus safety [ Time Frame: 4 months ]
    assessment of other tacrolimus related toxicity; the incidence rate of stinging sensation

  3. evaluation of safety of tacrolimus [ Time Frame: 4 months ]
    assessment of the degree of erythema using Eczema Area and Severity Index (EASI). The EASI is a composite score comprising ratings of the severity of erythema, oedema/induration/papulation, excoriations and lichenification; each on a scale from 0 to 3.

  4. evaluate the hydrocortisone safety [ Time Frame: 4 months ]
    assessment of the incidence rate of skin atrophy and skin infection.



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05324618


Contacts
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Contact: Amal A. Mohamed, Prof. +201224847367 amalahmedhcp@yahoo.com
Contact: Amal A. Elkholy +201060355448 amalanas9@gmail.com

Locations
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Egypt
Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute Recruiting
Cairo, Egypt, 123456
Contact: Amal A. Mohamed, Prof    01224847367    amalahmedhcp@yahoo.com   
Sponsors and Collaborators
Ain Shams University
National Hepatology & Tropical Medicine Research Institute
Investigators
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Principal Investigator: Amal A. Mohamed Department of Biochemistry, National Hepatology and Tropical Medicine Research institute
Publications:
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Responsible Party: Ain Shams University
ClinicalTrials.gov Identifier: NCT05324618    
Other Study ID Numbers: Tacrolimus vs Hydrocortisone
First Posted: April 12, 2022    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ain Shams University:
Tacrolimus
Hydrocortisone
Atopic
Dermatits
children
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents