Serotonin Levels in Atopic Dermatitis Patients

NCT ID: NCT03471819

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-04-30

Brief Summary

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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

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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

Conditions

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Dermatologic Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients withf Atopic Dermatitis

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

Serum serotonin level

Intervention Type DIAGNOSTIC_TEST

blood sample will be obtained to evaluate serum level of serotonin

healthy volunteers

Normal individuals not complaining of any dermatological diseases

Serum serotonin level

Intervention Type DIAGNOSTIC_TEST

blood sample will be obtained to evaluate serum level of serotonin

Interventions

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Serum serotonin level

blood sample will be obtained to evaluate serum level of serotonin

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aya Ahmed Mohamed Abdelbary

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia A Negm, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Eman R Hofny, Professor

Role: CONTACT

01005298992 ext. 02

Ayman M Mahran, Lecturer

Role: CONTACT

01009948311 ext. 02

References

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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.

Reference Type BACKGROUND
PMID: 28208011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14636205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29471919 (View on PubMed)

Other Identifiers

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SLAD

Identifier Type: -

Identifier Source: org_study_id

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