NCT03471819

Brief Summary

Atopic dermatitis (AD) is a chronic pruritic inflammatory skin disease of unknown aetiology. Global prevalence rates range from 1%-20%.AD is often worsened by stress and anxiety.Plasma levels of 5-HT were found to be positively correlated with the disease severity.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

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

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

March 14, 2018

Last Update Submit

March 20, 2018

Conditions

Keywords

Atopic Dermatitisserotonin

Outcome Measures

Primary Outcomes (1)

  • SCORAD

    Scoring Atopic Dermatitis "SCORAD" is a clinical tool for assessing the severity of AD as objectively as possible. It includes: A: Spread B: Intensity C: Subjective symptoms

    one month

Secondary Outcomes (1)

  • Beck's depression score (Arabic version)

    one month

Study Arms (2)

Patients withf Atopic Dermatitis

Diagnosis is based upon American Academy of Dermatology recommendations for Diagnostic Criteria 2014.

Diagnostic Test: Serum serotonin level

healthy volunteers

Normal individuals not complaining of any dermatological diseases

Diagnostic Test: Serum serotonin level

Interventions

Serum serotonin levelDIAGNOSTIC_TEST

blood sample will be obtained to evaluate serum level of serotonin

Patients withf Atopic Dermatitishealthy volunteers

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients with the clinical diagnosis of AD and 30 age and sex-matched apparently healthy volunteers will be included in this study

You may qualify if:

  • All patients with the clinical diagnosis of AD.
  • Age more than 2

You may not qualify if:

  • Age less than 2 years.
  • Any concomitant systemic or dermatological disease.
  • Patients on any topical or systemic treatment during the past one month.
  • Uncooperative patients.
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Abdel-Hafez K, Abdel-Aty MA, Hofny ER. Prevalence of skin diseases in rural areas of Assiut Governorate, Upper Egypt. Int J Dermatol. 2003 Nov;42(11):887-92. doi: 10.1046/j.1365-4362.2003.01936.x.

    PMID: 14636205BACKGROUND
  • Gooderham MJ, Hong HC, Eshtiaghi P, Papp KA. Dupilumab: A review of its use in the treatment of atopic dermatitis. J Am Acad Dermatol. 2018 Mar;78(3 Suppl 1):S28-S36. doi: 10.1016/j.jaad.2017.12.022.

    PMID: 29471919BACKGROUND
  • Afzal R, Shim WS. Glucosylsphingosine Activates Serotonin Receptor 2a and 2b: Implication of a Novel Itch Signaling Pathway. Biomol Ther (Seoul). 2017 Sep 1;25(5):497-503. doi: 10.4062/biomolther.2016.207.

    PMID: 28208011BACKGROUND

MeSH Terms

Conditions

Skin DiseasesDermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dalia A Negm, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman R Hofny, Professor

CONTACT

Ayman M Mahran, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

April 1, 2018

Primary Completion

March 31, 2019

Study Completion

April 30, 2019

Last Updated

March 22, 2018

Record last verified: 2018-03