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

Sponsor

Fakultas Kedokteran Universitas Indonesia (Other)

Overall Status

Unknown status

CT.gov ID

NCT04018131

Collaborator

(none)

Enrollment

Location

Arms

27.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Immunoglobulin E Concentration, Serum	Drug: Cimetidine Drug: Placebos	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 26, 2018

Anticipated Primary Completion Date :

Mar 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cimetidine	Drug: Cimetidine Antihistamine 2 antagonist
Placebo Comparator: Placebo	Drug: Placebos Placebo drug

Arm

Intervention/Treatment

Active Comparator: Cimetidine

Drug: Cimetidine

Antihistamine 2 antagonist

Placebo Comparator: Placebo

Drug: Placebos

Placebo drug

Outcome Measures

Primary Outcome Measures

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

Interleukin-4 change [0, 8 weeks]
Change of Interleukin-4
Interleukin-12 change [0, 8 weeks]
Change of Interleukin-12
Interferon Gamma change [0, 8 weeks]
Change of Interferon Gamma

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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