Contribution of Skin Color in Stabilization of Active Cases of Vitiligo by Narrow Band UVB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-11-30

Brief Summary

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Vitiligo is a disease in which autoimmunity plays a major role. Multiple treatment options are available, of which narrow-band UVB is a cornerstone, acting through immunosuppression and repigmentation by stimulating reservoir melanocytes.

It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier.

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Detailed Description

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Vitiligo is acquired depigmentation disorder. Several theories were hypothesized for causing vitiligo, of which the autoimmune theory is the most accepted.

The main targets of therapy are stabilization of the disease activity through immunosuppression, and repigmentation through stimulation of reservoir melanocytes proliferation and migration.

Narrow band ultraviolet phototherapy (NB-UVB) remains the cornerstone treatment of vitiligo. NB-UVB can induce both immunosuppression and repigmentation. Several factors can modulate the efficacy of NB-UVB therapy in treatment of vitiligo cases, including patient's age, lesion site, duration of the disease, and duration of the therapy.

The immunosuppressive function of NB-UVB was first detected in 1963 by Hanisko and Suskind, who observed that the contact hypersensitivity response in skin sensitized to dinitrochlorobenzene (DNCB) was reduced if skin was previously exposed to suberythemal doses of UVB.

Present evidence suggests that UVB suppress immune system through generation of T-suppressor cells, which inhibit the effector cells of Th1 type. It appears that UV-induced immunosuppression depresses the function of Th1 cells and enhances the activity of Th2 cells via cytokines such as Interleukin 10.

It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier. However, skin was previously divided to UVB-resistant and UVB-sensitive (UVB-R and UVB-S) based on the contact hypersensitivity testing, regardless of the skin type. Moreover, A study on NB-UVB phototherapy for psoriasis revealed that photoadaptation during NB-UVB therapy Is Independent of skin type.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

100 patients with non-segmental vitiligo are randomized to either NB-UVB therapy with placebo versus NB-UVB combined with mini-oral pulse steroids therapy. Vitligo activity will be assessed according to the VIDA scoring system. Skin type, extent of vitiligo using VES score, photography of all areas according to the VES areas at a fixed distance of 50 cm from the patient, and using a 1 cm diameter circular white sticker for reference later will be done. All patients will receive NB-UVB phototherapy at starting dose of 0.3 J/cm2, 3 times per week for 6 months (72 sessions) with gradually increasing increments according until faint erythema is attained at which point the dose is fixed. 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Masking involves only oral therapy; 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.

The investigators are blinded.

Study Groups

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Active

50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.

Group Type ACTIVE_COMPARATOR

Oral dexamethasone minipulse

Intervention Type DRUG

50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.

Placebo

50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments

Interventions

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Oral dexamethasone minipulse

50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.

Intervention Type DRUG

Placebo oral tablet

50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments

Intervention Type DRUG

Other Intervention Names

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Narrow band UVB Narrow band UVB

Eligibility Criteria

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Inclusion Criteria

* Active cases of non-segmental vitiligo, VIDA +2 or more.
* All skin types
* Age above 6 years, both sexes.

Exclusion Criteria

* Contraindications to NB-UVB ( photosensitive skin disorders, skin malignancy, patients on photosensitizing medications)
* Contraindications to mini-pulse steroid therapy (uncontrolled diabetes or hypertension, peptic ulcer)
* Stable disease (VIDA 0 \& -1) and activity more than 6 months ago (VIDA +1).
* The use of other treatment for vitiligo during the 3 months previous to enrollment.

Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No