- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039451
Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
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.
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amira Abdel-Motaleb
- Phone Number: 01005263721
- Email: Amiraali21@yahoo.com
Study Contact Backup
- Name: Yasmin Tawfik
- Phone Number: 01006033331
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age.
Exclusion Criteria:
- no exclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Find the possible precipitating factors affecting.
Time Frame: 2 months
|
obtained from history of what exaggerate or decrease the disease.
|
2 months
|
Types of psoriasis and vitiligo in Assiut governorate
Time Frame: 2 months
|
Dermatological examination will be done to find the distribution and extent of the diseases to determine the types.
|
2 months
|
Severity of psoriasis in Assiut patients
Time Frame: 2 months
|
Scoring system will be fulfilled:- Psoriasis area and severity index.
|
2 months
|
Impact of psoriasis and on Assiut patients
Time Frame: 2 months
|
Questionnaire will be fulfilled:- Quality of life of psoriasis patients.
|
2 months
|
Severity of vitiligo in Assiut patients
Time Frame: 2 months
|
Scoring system will be fulfilled:- Vitiligo area severity index score.
|
2 months
|
Impact of vitiligo and on Assiut patients
Time Frame: 2 months
|
Questionnaire will be fulfilled:- Quality of life of vitiligo patients.
|
2 months
|
Extent of vitiligo
Time Frame: 2 months
|
Scoring system will be fulfilled:- vitiligo extent score
|
2 months
|
Finding associated comorbidities
Time Frame: 2 months
|
general examination including joint examination to find associated diseases.
|
2 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
- Alikhan 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.
- Ezzedine 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.
- Salah 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.
- 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.
- Lebwohl M. Psoriasis. Lancet. 2003 Apr 5;361(9364):1197-204. doi: 10.1016/S0140-6736(03)12954-6.
- Finlay 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.
- Raychaudhuri 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.
- CAPMAS (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.
- Robinson 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.
- van 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.
- McKenna 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.
- Marissa D. Newman and Jeffrey M. Weinberg (2008): The pathophysiology of psoriasis: Treatment of psoriasis; 12,19,11-23.
- Farber EM and Nail L. (1998): Natural history and genetics. Psoriasis, 3rd edn. Marcel Dekker, New York, 1998: 107-157.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POPAVIassiutGE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China