Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo
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|ClinicalTrials.gov Identifier: NCT03199664|
Recruitment Status : Unknown
Verified September 2018 by Noha Samir, South Valley University.
Recruitment status was: Recruiting
First Posted : June 27, 2017
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Radiation: NB-UVB Combination Product: NB-UVB & Tacrolimus 0.03%||Phase 4|
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.
A randomized controlled trial.
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.
- Wash out period: ( 4 weeks) During this period, initial medical evaluation will be performed, social demographic data will be collected and patients will be enrolled after obtaining a written consent.
- Test period: (6 months) *Randomization: at the initial visit (visit 0), following the wash out period and before the start of treatment, patients will be randomly assigned to 2 treatment groups; Group (A) : patients will receive NB-UVB sessions twice weekly for 6 months. Initial dose will be 100 mJ/cm2, the dose will be increased by 10% per session.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Active Comparator: Group A (NB-UVB)
Intervention: patients will be treated with Narrow band ultra violet rays alone for 6 months
NB-UVB given twice weekly for 6 months
Active Comparator: Group B ( combined NB-UVB & Tacrolimus)
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 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) [ Time Frame: baseline to 9 months ]
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].
- Vitiligo Disease Activity (VIDA) score [ Time Frame: baseline to 9 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199664
|Contact: Noha Samir, MBBChfirstname.lastname@example.org|
|Contact: Ramdan Saleh, MDemail@example.com|
|Study Director:||Ramdan Saleh, MD||Sohag Faculty of Medicine, Sohag university|