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Serotonin Levels in Atopic Dermatitis Patients

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ClinicalTrials.gov Identifier: NCT03471819
Recruitment Status : Unknown
Verified March 2018 by Aya Ahmed Mohamed Abdelbary, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 21, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Aya Ahmed Mohamed Abdelbary, Assiut University

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.

Condition or disease Intervention/treatment
Dermatologic Disease Diagnostic Test: Serum serotonin level

Detailed Description:

Atopic dermatitis (AD) is a chronic pruritic inflammatory skin disease of unknown aetiology. The condition typically starts in infancy with changing presentations over the years. Incessant pruritus is the main symptom.

Main findings include: xerosis, eczematous lesions, Ig E reactivity, relapsing course and personal or family history of other atopic diatheses .Global prevalence rates range from 1%-20%.

AD is often worsened by stress and anxiety. Moreover, a mutual relationship between the neuroendocrine system and the immune system; including the skin has been suggested. Different mediators are responsible for this relation. Serotonin is considered as one of the most important responsible mediators (5-hydroxy-tryptamine; 5-HT) .

Patients with AD have been reported to have high serum levels of 5-HT. Moreover, plasma levels of 5-HT were found to be positively correlated with the disease severity. However and to the best of the investigators' knowledge, no studies have addressed this point in Egypt.

Treatment of AD includes: Elimination of triggers, emollients, topical therapies, and systemic modalities including SSRIs (Selective Serotonin Reuptake Inhibitors) and TCAs (Tricyclic Antidepressants) in certain cases. SSRIs block the reuptake of serotonin, thus increase the concentration of serotonin within synaptic clefts. The mechanism of action in relation to pruritus is not understood, but SSRIs have been used to treat atopic dermatitis associated pruritus

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Serotonin Levels in Atopic Dermatitis Patients and Its Relation to Disease Severity
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Group/Cohort Intervention/treatment
Patients withf Atopic Dermatitis
Diagnosis is based upon American Academy of Dermatology recommendations for Diagnostic Criteria 2014.
Diagnostic Test: Serum serotonin level
blood sample will be obtained to evaluate serum level of serotonin

healthy volunteers
Normal individuals not complaining of any dermatological diseases
Diagnostic Test: Serum serotonin level
blood sample will be obtained to evaluate serum level of serotonin




Primary Outcome Measures :
  1. SCORAD [ Time Frame: one month ]

    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



Secondary Outcome Measures :
  1. Beck's depression score (Arabic version) [ Time Frame: one month ]
    its a psychiatric 13 items questionnaire to determine the severity of depression



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471819


Contacts
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Contact: Eman R Hofny, Professor 01005298992 ext 02 e_riad@yahoo.com
Contact: Ayman M Mahran, Lecturer 01009948311 ext 02 aymanderma@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Dalia A Negm, Lecturer Assiut University
Publications:
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Responsible Party: Aya Ahmed Mohamed Abdelbary, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03471819    
Other Study ID Numbers: SLAD
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aya Ahmed Mohamed Abdelbary, Assiut University:
Atopic Dermatitis
serotonin
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs