Clinical trial NCT03199664: Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo
Official title: Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitiligo
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: baseline to 9 months
Secondary outcomes:
measure: Vitiligo Disease Activity (VIDA) score
timeFrame: baseline to 9 months
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South valley university
Study officials:
affiliation: Sohag Faculty of Medicine, Sohag university
name: Ramdan Saleh, MD
role: STUDY_DIRECTOR
References: