Dermatologic DiseaseNCT03471819
Serotonin Levels in Atopic Dermatitis Patients
An observational study of Dermatologic Disease, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatologic Disease
- What is being tested?
- Serum serotonin level
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- All patients with the clinical diagnosis of AD.
- Age more than 2
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serotonin Levels in Atopic Dermatitis Patients and Its Relation to Disease Severity
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.
Read the 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
- Conditions
- Dermatologic Disease
- Being tested
- Serum serotonin level
- Keywords
- Atopic Dermatitis, serotonin
- Medical subject headings
- Skin Diseases, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum serotonin levelDiagnostic test
blood sample will be obtained to evaluate serum level of serotonin
| Study group | Role | What they receive |
|---|---|---|
| Patients withf Atopic Dermatitis | Diagnosis is based upon American Academy of Dermatology recommendations for Diagnostic Criteria 2014. Receives: Diagnostic Test: Serum serotonin level | |
| healthy volunteers | Normal individuals not complaining of any dermatological diseases Receives: Diagnostic Test: Serum serotonin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Secondary outcomes (1)
Beck's depression score (Arabic version)
its a psychiatric 13 items questionnaire to determine the severity of depression
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dermatologic DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Mohamed Abdelbary, Assiut University
- Investigators
- Dalia A Negm, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471819
- Sponsor's protocol ID
- SLAD
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14636205Gooderham 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.
PubMed 29471919Afzal 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.
PubMed 28208011
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin Levels in Atopic Dermatitis Patients and Its Relation to Disease Severity
- ClinicalTrials.gov ID
- NCT03471819
- Acronym / sponsor ID
- SLAD
- Conditions
- Dermatologic Disease
- Keywords
- Atopic Dermatitis, serotonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients withf Atopic Dermatitis | – | Diagnostic Test: Serum serotonin levelDiagnosis is based upon American Academy of Dermatology recommendations for Diagnostic Criteria 2014. |
| healthy volunteers | – | Diagnostic Test: Serum serotonin levelNormal individuals not complaining of any dermatological diseases |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- All patients with the clinical diagnosis of AD.
- Age more than 2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum serotonin levelblood sample will be obtained to evaluate serum level of serotonin | Diagnostic test | Patients withf Atopic Dermatitis, healthy volunteers |
Primary outcome
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
1 secondary outcome
Beck's depression score (Arabic version)
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 14636205Abdel-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.
- Background: PubMed 29471919Gooderham 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.
- Background: PubMed 28208011Afzal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia A Negm, Lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatologic Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman R Hofny, Professor (01005298992 ext. 02, e_riad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471819, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.