VitiligoNCT06877000
Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment
An observational study of Vitiligo, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- VITIQOL questionnaire
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Adult
Study population: 200 cases and 200 control will be selected from vitiligo clinic Assiut university
Who may be able to join
- 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
Who cannot join
- Patients with other major skin disease affecting QOL . Patient with chronic diseases as diabetes mellitus and hypertension Not working patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yasmin Mo Tawfik, Assprof contact
About this study
Official title: 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
Read the 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 .
- Conditions
- Vitiligo
- Being tested
- VITIQOL questionnaire
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITIQOL questionnaireOther
Also called WPAI questionnaire and GSE scale
16 questions questionnaire measure effect of vitiligo on quality of life
| Study group | Role | What they receive |
|---|---|---|
| Working vitiligo patient | Employed moderate to severe vitiligo patients Receives: Other: VITIQOL questionnaire | |
| Working not diseased individuals | Employed healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic validated version of vitiligo specific quality of life instrument VITIQOL
A translated version will help to measure impact of vitiligo in Arabs
Measured: 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
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
Measured: Baseline
patients with more severe vitiligo have low work productivity and more activity impairment
Work Productivity and Activity impairments questionnaire is a 6 question questionnaire consists of four consists of four metric :
- Absenteeism (the percentage of work time missed)
- Presentism (the percentage of impairment experienced while at work)
- Overall work productivity loss (an estimate of combination of absenteeism and presentism)
- Activity impairment (the percentage of impairment in daily activities) WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Salah Ahmed Abdelhady, Assiut University
- Investigators
- Esraa Sa Ahmed, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877000
- Sponsor's protocol ID
- Vitiligo quality of life
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22365883Rosmarin 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.
PubMed 38824482
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment Among Patients in Upper Egypt
- ClinicalTrials.gov ID
- NCT06877000
- Acronym / sponsor ID
- Vitiligo quality of life
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Mar 2025 (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.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working vitiligo patient | – | Other: VITIQOL questionnaireEmployed moderate to severe vitiligo patients |
| Working not diseased individuals | – | –Employed healthy individuals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- 200 cases and 200 control will be selected from vitiligo clinic Assiut university
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with other major skin disease affecting QOL . Patient with chronic diseases as diabetes mellitus and hypertension Not working patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VITIQOL questionnaireAlso: WPAI questionnaire and GSE scale16 questions questionnaire measure effect of vitiligo on quality of life | Other | Working vitiligo patient |
Primary outcome
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
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
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 : 1. Absenteeism (the percentage of work time missed) 2. Presentism (the percentage of impairment experienced while at work) 3. Overall work productivity loss (an estimate of combination of absenteeism and presentism) 4. Activity impairment (the percentage of impairment in daily activities) WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- BackgroundAttallah, 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.
- Background: PubMed 22365883Lilly 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.
- Background: PubMed 38824482Rosmarin 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.
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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.
Yasmin Mo Tawfik, Assprof contact
Esraa Sa Ahmed, Resident principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Assiut University.
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: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Sa Ahmed Abdelhady, Resident (01097521695, Esraa.14224132@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic validated version of vitiligo specific quality of life instrument VITIQOL (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06877000, which also lists 3 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 14 Mar 2025.