Clinical trial NCT04018131: The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atopic Dermatitis
Immunoglobulin E Concentration, Serum
Keywords: Atopic Dermatitis
Cimetidine
Immunoglobulin E
Interleukin-4
Interleukin-12
Interferon Gamma
SCORAD
Treatment
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: SCORAD change
timeFrame: 0, 2, 4, 6, 8 weeks
measure: Immunoglobulin E change
timeFrame: 0, 8 weeks
Secondary outcomes:
measure: Interleukin-4 change
timeFrame: 0, 8 weeks
measure: Interleukin-12 change
timeFrame: 0, 8 weeks
measure: Interferon Gamma change
timeFrame: 0, 8 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine Universitas Indonesia
state: Jakarta
Study officials:
References:
citation: Novianto E, Jacoeb TNA, Indriatmi W, Suhendro, Setiabudy R, Setiabudy RD, Abdullah M, Rengganis I, Suwarsa O, Soebaryo RW. Effectiveness of Cimetidine as Adjuvant Therapy in the Treatment of Acute-Extrinsic Atopic Dermatitis: A Double-Blind Randomized Controlled Trial. Dermatol Ther (Heidelb). 2022 Mar;12(3):715-726. doi: 10.1007/s13555-022-00688-z. Epub 2022 Feb 17.