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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atopic Dermatitis, Immunoglobulin E Concentration, Serum

Intervention / Treatment
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* Drug: Cimetidine
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cimetidine<br> | Drug: Cimetidine<br>* Antihistamine 2 antagonist<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebos<br>* Placebo drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD change | 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 | 0, 2, 4, 6, 8 weeks | 
| Immunoglobulin E change | Change of Immunoglobulin E | 0, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-4 change | Change of Interleukin-4 | 0, 8 weeks | 
| Interleukin-12 change | Change of Interleukin-12 | 0, 8 weeks | 
| Interferon Gamma change | Change of Interferon Gamma | 0, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Cimetidine, Immunoglobulin E, Interleukin-4, Interleukin-12, Interferon Gamma, SCORAD, Treatment