The Efficacy of Cimetidin for Acute - Extrinsic Atopic De... | NCT04018131

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

NCT04018131

Sponsor

Fakultas Kedokteran Universitas Indonesia

Status

Unknown status

Last Update Posted

Oct 4, 2019Actual

Enrollment

26Estimated

Phase

Phase 3

Conditions

Atopic Dermatitis
Immunoglobulin E Concentration, Serum

Interventions

Cimetidine
Placebos

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2018Actual

Primary Completion Date

Mar 30, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Jul 10, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2019

Last Update Posted Date

Oct 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cimetidine	Active Comparator		Drug: Cimetidine
Placebo	Placebo Comparator		Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cimetidine	Drug	Antihistamine 2 antagonist	Cimetidine
Placebos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Immunoglobulin E change	Change of Immunoglobulin E	0, 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Interleukin-4 change	Change of Interleukin-4	0, 8 weeks
Interleukin-12 change	Change of Interleukin-12	0, 8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Endi Novianto	Contact	+628161309063		drendinovianto@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Universitas Indonesia	Recruiting	Jakarta Pusat	Jakarta Special Capital Region	10430	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35175572	Derived	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.

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D007093	Imidazoles
D001393