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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2020-06-30

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.

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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.

Conditions

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Atopic Dermatitis Immunoglobulin E Concentration, Serum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cimetidine

Group Type ACTIVE_COMPARATOR

Cimetidine

Intervention Type DRUG

Antihistamine 2 antagonist

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo drug

Interventions

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Cimetidine

Antihistamine 2 antagonist

Intervention Type DRUG

Placebos

Placebo drug

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No