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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04018131
• Other study ID #: 0071
• Status: Recruiting
• Phase: Phase 3
• Start date: March 26, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Endi Novianto
• Phone: +628161309063
• Email: drendinovianto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: June 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Immunoglobulin E Concentration, Serum

Intervention

Drug:
• Cimetidine
Antihistamine 2 antagonist
• Placebos
Placebo drug

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Immunoglobulin E change	Change of Immunoglobulin E	0, 8 weeks
Secondary	Interleukin-4 change	Change of Interleukin-4	0, 8 weeks
Secondary	Interleukin-12 change	Change of Interleukin-12	0, 8 weeks
Secondary	Interferon Gamma change	Change of Interferon Gamma	0, 8 weeks