Clinical trial NCT06877000: Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment
Official title: Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment Among Patients in Upper Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vitiligo
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 cases and 200 control will be selected from vitiligo clinic Assiut university

Brief summary: 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

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Arabic validated version of vitiligo specific quality of life instrument VITIQOL
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: patients with more severe vitiligo have low work productivity and more activity impairment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Esraa Sa Ahmed, Resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.