Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt

Psoriasis Clinical Trial

Official title:

Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04039451
• Other study ID #: POPAVIassiutGE
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Amira Abdel-Motaleb
• Phone: 01005263721
• Email: Amiraali21[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: May 31, 2020
• Est. primary completion date: February 29, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Vitiligo

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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

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. Review. — View Citation

CAPMAS (2018): The Central Agency for Public Mobilization and Statistics (CAPMAS). The Annual Book of National Statistics. Cairo, Egypt: 2018: 8.

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. Review. — View Citation

Farber EM and Nail L. (1998): Natural history and genetics. Psoriasis, 3rd edn. Marcel Dekker, New York, 1998: 107-157.

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. — View Citation

Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. — View Citation

Lebwohl M. Psoriasis. Lancet. 2003 Apr 5;361(9364):1197-204. Review. — View Citation

Marissa D. Newman and Jeffrey M. Weinberg (2008): The pathophysiology of psoriasis: Treatment of psoriasis; 12,19,11-23.

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. — View Citation

Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. Review. — View Citation

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. Review. — View Citation

Raychaudhuri SP, Farber EM. The prevalence of psoriasis in the world. J Eur Acad Dermatol Venereol. 2001 Jan;15(1):16-7. — View Citation

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. Review. — View Citation

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. — View Citation

van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taïeb 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months
Secondary	Find the possible precipitating factors affecting.	obtained from history of what exaggerate or decrease the disease.	2 months
Secondary	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.	2 months
Secondary	Severity of psoriasis in Assiut patients	Scoring system will be fulfilled:- Psoriasis area and severity index.	2 months
Secondary	Impact of psoriasis and on Assiut patients	Questionnaire will be fulfilled:- Quality of life of psoriasis patients.	2 months
Secondary	Severity of vitiligo in Assiut patients	Scoring system will be fulfilled:- Vitiligo area severity index score.	2 months
Secondary	Impact of vitiligo and on Assiut patients	Questionnaire will be fulfilled:- Quality of life of vitiligo patients.	2 months
Secondary	Extent of vitiligo	Scoring system will be fulfilled:- vitiligo extent score	2 months
Secondary	Finding associated comorbidities	general examination including joint examination to find associated diseases.	2 months