Serotonin Levels in Atopic Dermatitis Patients

Dermatologic Disease Clinical Trial

Official title:

Serotonin Levels in Atopic Dermatitis Patients and Its Relation to Disease Severity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03471819
• Other study ID #: SLAD
• Status: Not yet recruiting
• First received: March 14, 2018
• Last updated: March 20, 2018
• Start date: April 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Eman R Hofny, Professor
• Phone: 01005298992
• Email: e_riad[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Dermatologic Disease
• Eczema
• Skin Diseases

Intervention

Diagnostic Test:
• Serum serotonin level
blood sample will be obtained to evaluate serum level of serotonin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

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(3S1):S28-S36. doi: 10.1016/j.jaad.2017.12.022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Beck's depression score (Arabic version)	its a psychiatric 13 items questionnaire to determine the severity of depression	one month