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

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Atopic Dermatitis; Immunoglobulin E Concentration, Serum

Treatments: Drug: Cimetidine; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04018131

0071

Details and patient eligibility

About

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 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Cimetidine

Active Comparator group

Treatment:

Drug: Cimetidine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebos