NCT04030988

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

April 22, 2019

Last Update Submit

July 22, 2019

Conditions

Vitiligo

Keywords

VitiligoNarrow-band UVBSkin colorMinipulse

Outcome Measures

Primary Outcomes (4)

  • 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    A 5 cc blood sample will be withdrawn from each patient for: ELISA assessment of CXCL-10 (Pg/ml)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    A 5 cc blood sample will be withdrawn from each patient for: PCR assessment of m-RNA of CXCL-10 as markers of disease activity.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.

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Oral dexamethasone minipulseDRUG

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.

Also known as: Narrow band UVB
Active
Placebo oral tabletDRUG

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

Also known as: Narrow band UVB
Placebo

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbaseya, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mahy ElBassiouny, Ass.Lecturer

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahy ElBassiouny, Ass.Lecturer

CONTACT

002 01002202651mahyelbasyouni@gmail.com

Marwa Abdallah, Professor

CONTACT

002 01001166299marwa_abdallah@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

April 22, 2019

First Posted

July 24, 2019

Study Start

November 1, 2018

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Methodology and outcome of the study is palnned to be published in an international medical journal with sharing participants data.

Locations

EG(1)