Serotonin Levels in Atopic Dermatitis Patients

• Conditions: Dermatologic Disease
• Interventions: Diagnostic Test: Serum serotonin level

• Registration Number: NCT03471819
• Lead Sponsor: 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.

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

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-19
• Last Update Submitted: 2018-03-20
• Study First Posted: 2018-03-21
• Last Update Posted: 2018-03-22
• Study Start: 2018-04-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy volunteers	Serum serotonin level	Normal individuals not complaining of any dermatological diseases
Patients withf Atopic Dermatitis	Serum serotonin level	Diagnosis is based upon American Academy of Dermatology recommendations for Diagnostic Criteria 2014.

Primary Outcome Measures

Name	Time	Method
SCORAD	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

Name	Time	Method
Beck's depression score (Arabic version)	one month	its a psychiatric 13 items questionnaire to determine the severity of depression