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

Primary Purpose

Atopic Dermatitis, Immunoglobulin E Concentration, Serum

Status
Unknown status
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Cimetidine
Placebos
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Cimetidine, Immunoglobulin E, Interleukin-4, Interleukin-12, Interferon Gamma, SCORAD, Treatment

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Medicine Universitas IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cimetidine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
Immunoglobulin E change
Change of Immunoglobulin E

Secondary Outcome Measures

Interleukin-4 change
Change of Interleukin-4
Interleukin-12 change
Change of Interleukin-12
Interferon Gamma change
Change of Interferon Gamma

Full Information

First Posted
July 10, 2019
Last Updated
October 2, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04018131
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Immunoglobulin E Concentration, Serum
Keywords
Atopic Dermatitis, Cimetidine, Immunoglobulin E, Interleukin-4, Interleukin-12, Interferon Gamma, SCORAD, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cimetidine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cimetidine
Intervention Description
Antihistamine 2 antagonist
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo drug
Primary Outcome Measure Information:
Title
SCORAD change
Description
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
Time Frame
0, 2, 4, 6, 8 weeks
Title
Immunoglobulin E change
Description
Change of Immunoglobulin E
Time Frame
0, 8 weeks
Secondary Outcome Measure Information:
Title
Interleukin-4 change
Description
Change of Interleukin-4
Time Frame
0, 8 weeks
Title
Interleukin-12 change
Description
Change of Interleukin-12
Time Frame
0, 8 weeks
Title
Interferon Gamma change
Description
Change of Interferon Gamma
Time Frame
0, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Endi Novianto
Phone
+628161309063
Email
drendinovianto@gmail.com
Facility Information:
Facility Name
Faculty of Medicine Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Endi Novianto, MD
Phone
+628161309063
Email
drendinovianto@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35175572
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.
Results Reference
derived

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

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