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

NCT04030988 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-24

No results posted yet for this study

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.

Conditions

  • Vitiligo

Interventions

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.

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

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Menia University

    collaborator UNKNOWN

  • Suez Canal University

    collaborator OTHER

  • Assiut University

    collaborator OTHER

  • Alexandria University

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mahy ElBassiouny, Ass.Lecturer · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-09-30
Completion
2019-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030988 on ClinicalTrials.gov