- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877000
Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment
Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment Among Patients in Upper Egypt
translate and validate the vitiligo specific quality of life (VITIQOL) questionnaire to Arabic language.
evaluate the effect of vitiligo on patient quality of life using vitiligo specific quality of life questionnaire (VitiQoL).
measure the impact of vitiligo on work productivity using work productivity and activity impairment questionnaire (WPAI) and general self efficacy scale (GSE) .
analyze how disease severity and location influence patients quality of life and work pro
Study Overview
Detailed Description
Vitiligo is a common disorder of depigmentation caused by the progressive destruction of melanocytes that affect the skin, hair and mucous membranes, clinically presenting as depigmented macules and leukotrichia.
Vitiligo was historically regarded as a cosmetic disorder; however, it is an immune disease as it affects patient well-being . It affects approximately 0.5-1% of the global population. A Study reported a prevalence of 1.2% in the Egyptian population.
Vitiligo is asymptomatic disease, so its effect on quality of life is much more related to psychological problems, such as lack of self-confidence unpleasant body images unsuccessful social relationships, and lower quality of marital relations, than the exclusive physical issues. It has been shown that patients with vitiligo are at risk of higher social discrimination and stigma Lesions that are more severe, on the face, or covering a greater BSA are more often associated with poorer outcomes and activity impairment.
Recently a study conducted in Egypt in 2023 noted that more than half of studied sample had low level of self-esteem and quality of life. While more than half of studied sample had moderate negative body image. Also, half of studied sample had moderate level of social problems .
limited studies have been conducted in Upper Egypt which assess life quality of patients with vitiligo and but those Studies employed non-specific tools like Dermatology Life Quality Index (DLQI).
Lilly et al have developed a reliable tool with high internal consistency named as Vitiligo specific Quality of life questionnaire(VITIQOL) that consists of 16 questions comprising of demographic and clinical parameters of the patients.
Also the work productivity and activity impairment among vitiligo patients in Egypt have not been assessed before .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Esraa Sa Ahmed Abdelhady, Resident
- Phone Number: 01097521695
- Email: Esraa.14224132@med.aun.edu.eg
Study Contact Backup
- Name: Yasmin Mo Tawfik, Assprof
- Phone Number: 01006033331
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults > 18 years and less than 60 years old diagnosed with vitiligo by a physician Patients willing to complete the survey questionnaires Patients who can speak Arabic
Exclusion Criteria:
- Patients with other major skin disease affecting QOL . Patient with chronic diseases as diabetes mellitus and hypertension Not working patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Working vitiligo patient
Employed moderate to severe vitiligo patients
|
16 questions questionnaire measure effect of vitiligo on quality of life
Other Names:
|
|
Working not diseased individuals
Employed healthy individuals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arabic validated version of vitiligo specific quality of life instrument VITIQOL
Time Frame: Baseline
|
A translated version will help to measure impact of vitiligo in Arabs
|
Baseline
|
|
Patients with severe vitiligo which will be measured by vitiligo area scoring index VASI score , will have lower quality-of-life on vitiligo specific quality of life instrument which have a score ranges from 0 to 90
Time Frame: Baseline
|
Vitiligo specific quality of life instrument have 15 questions each one has a likert scale from 0 to 6 , score ranges from 0-90 , patients with severe vitligo expect to have low score on the questionnaire
|
Baseline
|
|
patients with more severe vitiligo have low work productivity and more activity impairment
Time Frame: Baseline
|
Work Productivity and Activity impairments questionnaire is a 6 question questionnaire consists of four consists of four metric :
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esraa Sa Ahmed, Resident, Assiut University
Publications and helpful links
General Publications
- Attallah, D. A., Abdullah, M. A. A., & Abou-Taleb, D. A. E. (2022). Effect of treatment on quality of life in Egyptian vitiligo patients using the Arabic version of Dermatology Life Quality Index. Journal of Current Medical Research and Practice, 7(2), 163-166.
- Lilly E, Lu PD, Borovicka JH, Victorson D, Kwasny MJ, West DP, Kundu RV. Development and validation of a vitiligo-specific quality-of-life instrument (VitiQoL). J Am Acad Dermatol. 2013 Jul;69(1):e11-8. doi: 10.1016/j.jaad.2012.01.038. Epub 2012 Feb 25.
- Rosmarin D, Soliman AM, Piercy J, Marwaha S, Anderson P, Camp HS. Health-Related Quality of Life Burden Among Adults with Vitiligo: Relationship to Disease Severity and Disease Location. Dermatol Ther (Heidelb). 2024 Jun;14(6):1633-1647. doi: 10.1007/s13555-024-01187-z. Epub 2024 Jun 2.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Vitiligo quality of life
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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