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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 : Recruiting
First Posted : June 27, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Noha Samir, South Valley University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitiligo Radiation: NB-UVB Combination Product: NB-UVB & Tacrolimus 0.03% Phase 4

Detailed Description:

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:

  • 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A (NB-UVB)
Intervention: patients will be treated with Narrow band ultra violet rays alone for 6 months
 Radiation: NB-UVB
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


Outcome Measures
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Primary Outcome Measures :
  1. 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].



Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients with clinical diagnosis of vitiligo.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Noha Samir, MBBCh 01001248106 noha_samir89@yahoo.com
Contact: Ramdan Saleh, MD 01005423054 salehr2010@yahoo.com

Locations
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Egypt
South valley university Recruiting
Qinā, Egypt
Contact: Noha Samir, MBBCh    01001248106    noha_samir89@yahoo.com   
Contact: Ramadan saleh, MD    01005423054    salehr2010@yahoo.com   
Sponsors and Collaborators
South Valley University
Investigators
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Study Director: Ramdan Saleh, MD Sohag Faculty of Medicine, Sohag university
More Information
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Responsible Party: Noha Samir, Dermatology resident at South Valley University Students' Hospital, South Valley University
ClinicalTrials.gov Identifier: NCT03199664     History of Changes
Other Study ID Numbers: tcrnbvtlg
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action