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

The Reflection of Skin Color on the Efficacy of Narrow Band UVB in Stabilization of Active Cases of Vitiligo

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.

Study Overview

• Status: Unknown
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Oral dexamethasone minipulse; Drug: Placebo oral tablet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Abbaseya
    • Cairo, Abbaseya, Egypt, 00202
      • Recruiting
      • Ain Shams University
      • Contact: Mahy ElBassiouny, Ass.Lecturer; Phone Number: 002 01002202651; Email: mahyelbasyouni@gmail.com
      • Contact: Marwa Abdallah, Professor; Phone Number: 002 01001166299; Email: marwa_abdallah@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Narrow band UVB
Placebo Comparator: 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.	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; Other Names: Narrow band UVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detecting number of participants with clinical activity of vitiligo	Appearance of new lesions or expansion of pre-existing lesions by clinical examination.	At 6 months after treatment.
Photography to detect activity of vitiligo	New lesions in each area will be counted.	Change from baseline (first visit) at 6 months after treatment.
Elevation of serum Vitiligo activity markers.	A 5 cc blood sample will be withdrawn from each patient for: ELISA assessment of CXCL-10 (Pg/ml)	Change from baseline at 6 months after treatment.
Elevation of PCR levels of serum Vitiligo activity markers	A 5 cc blood sample will be withdrawn from each patient for: PCR assessment of m-RNA of CXCL-10 as markers of disease activity.	Change from baseline at 6 months after treatment.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Alexandria University; Cairo University; Assiut University; Suez Canal University; Menia University
• Investigators: Principal Investigator: Mahy ElBassiouny, Ass.Lecturer, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Vitiligo; Narrow-band UVB; Skin color; Minipulse
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: u4xjkivz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Methodology and outcome of the study is palnned to be published in an international medical journal with sharing participants data.

Drug and device information, study documents

• 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.: No