The Efficacy of Cimetidin for Acute – Extrinsic Atopic Dermatitis Treated With Standard Therapy

Overview

Extrinsic – atopic dermatitis is characterized by increased of IgE serum levels. Acute extrinsic – atopic dermatitis is a type 1 hypersensitivity that involve various inflammatory mediator including Interleukin-4, Interleukin-12, and Interferon-Ɣ. Recent treatment of atopic dermatitis mainly focused on reducing the inflammation through topical and systemic regiments. However, no systemic medication could control the atopic dermatitis remission yet, and the current immunosuppressive agent used may cause many side effects if administered on a long term basis. In the future, treatment of atopic dermatitis were specifically targeted to inhibit the role of Th2. Cimetidine is H2 receptor antihistamine that has been widely used as gastrointestinal medication for a long time. Cimetidine could modulate the immune system by activating the Th1 and lowering the Th2 activity, and lowering the IgE levels thus reducing the severity of atopic dermatitis.

Full Title of Study: “The Efficacy of Cimetidin for Acute – Extrinsic Atopic Dermatitis Treated With Standard Therapy, a Study of Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ Serum Levels”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2020

Detailed Description

The aim of this study is to measure the efficacy of cimetidine for acute, extrinsic-atopic dermatitis treated with standard therapy using SCORAD as the clinical outcome. This study also measure Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ serum levels before and after treatment.

Interventions

  • Drug: Cimetidine
    • Antihistamine 2 antagonist
  • Drug: Placebos
    • Placebo drug

Arms, Groups and Cohorts

  • Active Comparator: Cimetidine
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • SCORAD change
    • Time Frame: 0, 2, 4, 6, 8 weeks
    • Scoring Atopic Dermatitis (SCORAD) is a score to indicate the severity of atopic dermatitis. The minimum score is 0, maximum score is 103. Mild 0 – 14 Moderate 15 – 39 Severe 40 – 103 The SCORAD before treatment was expected to be higher than after treatment. Outcome: change of SCORAD
  • Immunoglobulin E change
    • Time Frame: 0, 8 weeks
    • Change of Immunoglobulin E

Secondary Measures

  • Interleukin-4 change
    • Time Frame: 0, 8 weeks
    • Change of Interleukin-4
  • Interleukin-12 change
    • Time Frame: 0, 8 weeks
    • Change of Interleukin-12
  • Interferon Gamma change
    • Time Frame: 0, 8 weeks
    • Change of Interferon Gamma

Participating in This Clinical Trial

Inclusion Criteria

  • Atopic dermatitis patients diagnosed with Hanifin Rajka criteria – Acute extrinsic atopic dermatitis – IgE levels above 200 IU/mL – Minimum weight 15kg Exclusion Criteria:

  • Consumption of corticosteroid and systemic immunosuppressant within the last 2 weeks – Chronic lesion – Consumption of drugs that reacts with cimetidine – Disturbance in lab results including complete blood count, liver function, and renal function. – Other conditions that might increase IgE levels

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fakultas Kedokteran Universitas Indonesia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Endi Novianto, +628161309063, drendinovianto@gmail.com

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