A Phase 4 interventional study of NB-UVB and NB-UVB & Tacrolimus 0.03% in Vitiligo, sponsored by South Valley University. Status unknown at 1 site in Egypt. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by South Valley University · Phase 4, Interventional, and Treatment
The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months .All types of vitiligo will be included except universal vitiligo.
Study approval:
The study will be submitted for approval by the Scientific and Ethical Committees at Faculty of Medicine, South Valley University, Qena. An informed written consent will be obtained from all participants.
Study design:
A randomized controlled trial.
Study population:
The study will include patients who attend the outpatient Clinic of Dermatology, Venereology and Andrology, Faculty of Medicine, South Valley University, with clinical diagnosis of vitiligo. Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity will be excluded.
Methods:
Group (B) : patients will receive NB-UVB sessions twice weekly for 6 months with the same dose plus topical application of tacrolimus 0.03% ointment twice dialy for the first month of treatment and once dialy for the rest 5 months of treatment.
All Patients will be evaluated before the start of treatment (visit 0) and at monthly intervals for 6 months.
306 studies on the registry are indexed under Vitiligo; 70 are open to participants now.
This study's planned enrollment of 100 is above the median of 32 across 235 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Intervention: patients will be treated with Narrow band ultra violet rays alone for 6 months
Radiation: NB-UVB
Intervention: patients will be treated with NB-UVB \& Tacrolimus 0.03 % ointment for 6 months
Combination Product: NB-UVB & Tacrolimus 0.03%
NB-UVB given twice weekly for 6 months
NB-UVB given twice weekly for 6 months and tacrolimus 0.03 % ointment given for twice daily for the first month of treatment and once daily for the rest 5 months of treatment
Vitiligo Area Scoring Index (VASI)
The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites \[Hand Units\] ´ \[Residual depigmentation\].
Time frame: baseline to 9 months
Vitiligo Disease Activity (VIDA) score
The VIDA is a six-point scale for assessing vitiligo activity. Scoring is based on the individual's own opinion of the present disease activity over time. Active vitiligo involves either expansion of existing lesions or appearance of new lesions. Grading is as follows: VIDA Score +4 - Activity of 6 weeks or less duration; +3 - Activity of 6 weeks to 3 months; +2 - Activity of 3 - 6 months;+1 - Activity of 6 - 12 months; 0 - Stable for 1 year or more; and -1 - Stable with spontaneous repigmentation since 1 year or more. A low VIDA score indicates less activity.
Time frame: baseline to 9 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Sep 2018, 12 months.
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This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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