NCT04018131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

July 10, 2019

Last Update Submit

October 2, 2019

Conditions

Atopic DermatitisImmunoglobulin E Concentration, Serum

Keywords

Atopic DermatitisCimetidineImmunoglobulin EInterleukin-4Interleukin-12Interferon GammaSCORADTreatment

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • Interleukin-4 change

    0, 8 weeks

  • Interleukin-12 change

    0, 8 weeks

  • Interferon Gamma change

    0, 8 weeks

Study Arms (2)

Cimetidine

ACTIVE COMPARATOR
Drug: Cimetidine

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

CimetidineDRUG

Antihistamine 2 antagonist

Cimetidine
PlacebosDRUG

Placebo drug

Placebo

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Atopic dermatitis patients diagnosed with Hanifin Rajka criteria
  • Acute extrinsic atopic dermatitis
  • IgE levels above 200 IU/mL
  • Minimum weight 15kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35175572DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cimetidine

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Endi Novianto

CONTACT

+628161309063drendinovianto@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

March 26, 2018

Primary Completion

March 30, 2020

Study Completion

June 30, 2020

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)