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

Phase 3

• Conditions: Atopic Dermatitis; Immunoglobulin E Concentration, Serum
• Interventions: Drug: Placebos; Drug: Cimetidine

• Registration Number: NCT04018131
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-26
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04
• Primary Completion: 2020-03-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	-
Cimetidine	Cimetidine	-

Primary Outcome Measures

Name	Time	Method
SCORAD change	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	0, 8 weeks	Change of Immunoglobulin E

Secondary Outcome Measures

Name	Time	Method
Interleukin-12 change	0, 8 weeks	Change of Interleukin-12
Interleukin-4 change	0, 8 weeks	Change of Interleukin-4
Interferon Gamma change	0, 8 weeks	Change of Interferon Gamma

Trial Locations

Locations (1)

Faculty of Medicine Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia