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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04018131

Enrollment

Registered

2019-07-12

Start date

2018-03-26

Completion date

2020-06-30

Last updated

2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Immunoglobulin E Concentration, Serum

Keywords

Atopic Dermatitis, Cimetidine, Immunoglobulin E, Interleukin-4, Interleukin-12, Interferon Gamma, SCORAD, Treatment

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.

Interventions

DRUGCimetidine

Antihistamine 2 antagonist

DRUGPlacebos

Placebo drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Indonesia

Contacts

Primary ContactEndi Novianto

drendinovianto@gmail.com+628161309063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026