PsoriasisNCT04039451
Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
An observational study of Psoriasis and Vitiligo, run by Assiut University at 1 site in Egypt.
Trial summary
Psoriasis is a chronic, immune-mediated inflammatory skin disease, which ranges in severity from a few scattered red, scaly plaques to involvement of almost the entire body surface. Read more about this study
- Who is it for?
- Any age
- How many people
- 1,200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 31 May 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age.
Who may be able to join
- The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Yasmin Tawfik contact
About this study
Psoriasis is a chronic, immune-mediated inflammatory skin disease, which ranges in severity from a few scattered red, scaly plaques to involvement of almost the entire body surface. It may progressively worsen with age, or wax and wane in its severity; the degree of severity depends on inheritance and environmental factors.
It is a complex disease, multiple exogenous and endogenous stimuli incite already stimulated innate immune responses in genetically predetermined individuals. The disease process is a result of a network of cell types including T cells, dendritic cells and keratinocytes that, with the production of cytokines, generate a chronic inflammatory state.
Read more
Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes.
Its pathogenesis is still unclear, many mechanisms and theories have been suggested including autoimmunity, auto cytotoxicity, biochemical and neuronal mechanisms.
Read the detailed description
There are multiple patterns of psoriasis including plaque, guttate, pustular, inverse and erythrodermic, approximately 80% of patients present with plaque psoriasis which is clinically characterized by well demarcated erythematous plaques with overlying scales. These plaques can be intensely pruritic and bleed when manipulated, referred to as the Auspitz sign. Lesions are usually distributed symmetrically and frequently occur on the elbows, knees, lower back and scalp.
Prevalence of psoriasis is around 2-3% of the general population. A high prevalence of psoriasis at the rate of 11.8% has been reported from Kazach'ye, located in the Arctic region of the former Soviet Union.
In Egypt, the prevalence reported is around 3%. A study was done in hospitals of Damietta governorate reveals that prevalence of psoriasis is about 5%. Up to the investigator's knowledge the prevalence of psoriasis at Assuit governorate is not known till now.
Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.
Prevalence of vitiligo is 0.5%-2% of general population world-wide, without predilection for sex or race. A previous study on skin diseases I Assiut governorates reveals that prevalence of vitiligo was about 1.22%.
- Medical subject headings
- Psoriasis, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| people who live in rural areas in Assuit governorate | The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of psoriasis and vitiligo in Assuit governorate
Complete history will be obtained from patients: including name, age, sex, occupation, marital status, special habits and risk factors of psoriasis and vitiligo, including history of psoriasis and vitiligo (onset, course, duration, precipitating and previous treatments).
Measured: 6 months
Secondary outcomes (8)
Find the possible precipitating factors affecting.
obtained from history of what exaggerate or decrease the disease.
Measured: 2 months
Types of psoriasis and vitiligo in Assiut governorate
Dermatological examination will be done to find the distribution and extent of the diseases to determine the types.
Measured: 2 months
Severity of psoriasis in Assiut patients
Scoring system will be fulfilled:- Psoriasis area and severity index.
Measured: 2 months
Impact of psoriasis and on Assiut patients
Questionnaire will be fulfilled:- Quality of life of psoriasis patients.
Measured: 2 months
Severity of vitiligo in Assiut patients
Scoring system will be fulfilled:- Vitiligo area severity index score.
Measured: 2 months
Impact of vitiligo and on Assiut patients
Questionnaire will be fulfilled:- Quality of life of vitiligo patients.
Measured: 2 months
Extent of vitiligo
Scoring system will be fulfilled:- vitiligo extent score
Measured: 2 months
Finding associated comorbidities
general examination including joint examination to find associated diseases.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion29 Feb 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Hassan Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039451
- Sponsor's protocol ID
- POPAVIassiutGE
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
PubMed 23014338Lebwohl M. Psoriasis. Lancet. 2003 Apr 5;361(9364):1197-204. doi: 10.1016/S0140-6736(03)12954-6.
PubMed 12686053Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
PubMed 19641206Finlay AY, Khan GK, Luscombe DK, Salek MS. Validation of Sickness Impact Profile and Psoriasis Disability Index in Psoriasis. Br J Dermatol. 1990 Dec;123(6):751-6. doi: 10.1111/j.1365-2133.1990.tb04192.x.
PubMed 2265090Raychaudhuri SP, Farber EM. The prevalence of psoriasis in the world. J Eur Acad Dermatol Venereol. 2001 Jan;15(1):16-7. doi: 10.1046/j.1468-3083.2001.00192.x. No abstract available.
PubMed 11451313Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
PubMed 25596811Salah Eldin MM, Sami NA, Aly DG, Hanafy NS. Comparison Between (311-312 nm) Narrow Band Ultraviolet-B Phototherapy and (308 nm) Monochromatic Excimer Light Phototherapy in Treatment of Vitiligo: A Histopathological Study. J Lasers Med Sci. 2017 Summer;8(3):123-127. doi: 10.15171/jlms.2017.22. Epub 2017 Jun 27.
PubMed 29123631Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
PubMed 21839315Abdel-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 14636205CAPMAS (2018): The Central Agency for Public Mobilization and Statistics (CAPMAS). The Annual Book of National Statistics. Cairo, Egypt: 2018: 8.
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
PubMed 357213Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012 Mar;66(3):369-75. doi: 10.1016/j.jaad.2011.01.022. Epub 2011 Oct 29.
PubMed 22041254van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Speeckaert R. Development and Validation of the Vitiligo Extent Score (VES): an International Collaborative Initiative. J Invest Dermatol. 2016 May;136(5):978-984. doi: 10.1016/j.jid.2015.12.040. Epub 2016 Jan 28.
PubMed 26827762McKenna SP, Cook SA, Whalley D, Doward LC, Richards HL, Griffiths CE, Van Assche D. Development of the PSORIQoL, a psoriasis-specific measure of quality of life designed for use in clinical practice and trials. Br J Dermatol. 2003 Aug;149(2):323-31. doi: 10.1046/j.1365-2133.2003.05492.x.
PubMed 12932239Marissa D. Newman and Jeffrey M. Weinberg (2008): The pathophysiology of psoriasis: Treatment of psoriasis; 12,19,11-23.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
- ClinicalTrials.gov ID
- NCT04039451
- Acronym / sponsor ID
- POPAVIassiutGE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 31 Jul 2019 (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.
Psoriasis is a chronic, immune-mediated inflammatory skin disease, which ranges in severity from a few scattered red, scaly plaques to involvement of almost the entire body surface. It may progressively worsen with age, or wax and wane in its severity; the degree of severity depends on inheritance and environmental factors.
It is a complex disease, multiple exogenous and endogenous stimuli incite already stimulated innate immune responses in genetically predetermined individuals. The disease process is a result of a network of cell types including T cells, dendritic cells and keratinocytes that, with the production of cytokines, generate a chronic inflammatory state.
Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes.
Its pathogenesis is still unclear, many mechanisms and theories have been suggested including autoimmunity, auto cytotoxicity, biochemical and neuronal mechanisms.
Detailed description
There are multiple patterns of psoriasis including plaque, guttate, pustular, inverse and erythrodermic, approximately 80% of patients present with plaque psoriasis which is clinically characterized by well demarcated erythematous plaques with overlying scales. These plaques can be intensely pruritic and bleed when manipulated, referred to as the Auspitz sign. Lesions are usually distributed symmetrically and frequently occur on the elbows, knees, lower back and scalp.
Prevalence of psoriasis is around 2-3% of the general population. A high prevalence of psoriasis at the rate of 11.8% has been reported from Kazach'ye, located in the Arctic region of the former Soviet Union.
In Egypt, the prevalence reported is around 3%. A study was done in hospitals of Damietta governorate reveals that prevalence of psoriasis is about 5%. Up to the investigator's knowledge the prevalence of psoriasis at Assuit governorate is not known till now.
Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.
Prevalence of vitiligo is 0.5%-2% of general population world-wide, without predilection for sex or race. A previous study on skin diseases I Assiut governorates reveals that prevalence of vitiligo was about 1.22%.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| people who live in rural areas in Assuit governorate | – | –The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age.
Key inclusion criteria (1 listed)
- The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of psoriasis and vitiligo in Assuit governorate
Time frame: 6 months
Complete history will be obtained from patients: including name, age, sex, occupation, marital status, special habits and risk factors of psoriasis and vitiligo, including history of psoriasis and vitiligo (onset, course, duration, precipitating and previous treatments).
8 secondary outcomes
Find the possible precipitating factors affecting.
Time frame: 2 months
Types of psoriasis and vitiligo in Assiut governorate
Time frame: 2 months
Severity of psoriasis in Assiut patients
Time frame: 2 months
Impact of psoriasis and on Assiut patients
Time frame: 2 months
Severity of vitiligo in Assiut patients
Time frame: 2 months
Impact of vitiligo and on Assiut patients
Time frame: 2 months
Extent of vitiligo
Time frame: 2 months
Finding associated comorbidities
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Background: PubMed 23014338Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
- Background: PubMed 12686053Lebwohl M. Psoriasis. Lancet. 2003 Apr 5;361(9364):1197-204. doi: 10.1016/S0140-6736(03)12954-6.
- Background: PubMed 19641206Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
- Background: PubMed 2265090Finlay AY, Khan GK, Luscombe DK, Salek MS. Validation of Sickness Impact Profile and Psoriasis Disability Index in Psoriasis. Br J Dermatol. 1990 Dec;123(6):751-6. doi: 10.1111/j.1365-2133.1990.tb04192.x.
- Background: PubMed 11451313Raychaudhuri SP, Farber EM. The prevalence of psoriasis in the world. J Eur Acad Dermatol Venereol. 2001 Jan;15(1):16-7. doi: 10.1046/j.1468-3083.2001.00192.x. No abstract available.
- Background: PubMed 25596811Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
- Background: PubMed 29123631Salah Eldin MM, Sami NA, Aly DG, Hanafy NS. Comparison Between (311-312 nm) Narrow Band Ultraviolet-B Phototherapy and (308 nm) Monochromatic Excimer Light Phototherapy in Treatment of Vitiligo: A Histopathological Study. J Lasers Med Sci. 2017 Summer;8(3):123-127. doi: 10.15171/jlms.2017.22. Epub 2017 Jun 27.
- Background: PubMed 21839315Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
- 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.
- BackgroundCAPMAS (2018): The Central Agency for Public Mobilization and Statistics (CAPMAS). The Annual Book of National Statistics. Cairo, Egypt: 2018: 8.
- Background: PubMed 357213Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
- Background: PubMed 22041254Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012 Mar;66(3):369-75. doi: 10.1016/j.jaad.2011.01.022. Epub 2011 Oct 29.
- 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.
Yasmin Tawfik contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Vitiligo, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Amira Abdel-Motaleb (01005263721, Amiraali21@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of psoriasis and vitiligo in Assuit governorate (time frame: 6 months). 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 NCT04039451, which also lists 16 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 31 Jul 2019.