Oral Mini Pulse Dexamethasone in Pediatric Vitiligo

May 1, 2026 updated by: Nanis Aleem Abdul Moneim Ragab, Cairo University

The Efficacy and Safety of Oral Mini-pulse Dexamethasone in Active Non-segmental Vitiligo Within the Pediatric Age Group

The goal of this clinical trial is to learn if oral mini pulse (OMP) dexamethasone works to treat active vitiligo in children and also learn about the safety of this drug within this age group the main questions it aims to answer are does OMP halt activity in active vitiligo and what medical problems patients might experience while using the drug with special attention to linear growth. Researchers will give OMP dexamethasone to participating patients to see if the drug works to treat active vitiligo and whether it has any effect on linear growth. Participants will take OMP dexamethasone two fixed days per week for a period of 3 months. before starting treatment, patients will do baseline evaluation and investigations then monthly evaluation to monitor progress, report any side effects at the end of treatment period response to drug, lab values and growth will be evaluated then final evaluation of growth will be done after stoppage of drug.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Vitiligo is an autoimmune depigmenting skin disorder. Childhood Vitiligo (CV), defined as Vitiligo that begins before the age of 12 years, is common and may differ from post CV in terms of epidemiology, clinical picture, comorbidities and treatment options. Oral mini pulse (OMP) corticosteroids have been used successfully in both adults and children with active vitiligo. Pulsed regimens allow the achievement of the therapeutic outcome as well as better patient compliance while minimizing the adverse effects of daily steroids, However, its specific impact on linear growth in the pediatric population requires further evaluation. The aim of the current study is to evaluate the efficacy and safety of OMP dexamethasone in pediatric patients with active non-segmental vitiligo with special focus on linear growth.

Methodology: Male and female patients with active vitiligo defined as patients with Vitiligo disease activity score (VIDA) +3 and +4 patients with non-segmental vitiligo between 4-9 yrs will be included in the study. Baseline evaluation will include Vitiligo signs of activity score (VSAS) and Vitiligo area scoring index (VASI) scores, Routine lab investigations, HBA1c, cortisol am, ACTH am, blood pressure. Weight and height will be measured and plotted on WHO z score growth charts. Plain Xray of left hand and wrist for bone age will also be done. Patients will receive OMP dexamethasone in a dose of 0.1 mg/kg/day two consecutive days per week for 3 months. Topical treatment including topical betamethasone cream for body lesions and tacrolimus 0.1% cream for face lesions as well as puva sol /excimer laser will be allowed during the study. Patients will be monitored monthly to evaluate response and side effects. At the end of treatment period (3 months) the following parameters will be evaluated VSAS and VASI scores, weight and height plotted on WHO z scores growth charts. lab investigations including HBA1c, cortisol am and ACTH will be done one week after stoppage of treatment. 3 months after stoppage of treatment patients will be monitored for recurrence, weight and height will be measured and plotted on WHO z scores growth charts and bone age will be evaluated by plain Xray on left hand and wrist.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dermatology Outpatient Clinic, Kasr al Ainy Teaching Hospital, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Active (VIDA +3 & +4) non segmental vitiligo
  • Age between 4-9yrs
  • Males and Females
  • Children with height measurements within the percentile range 5-95% of normal values for their age.

Exclusion Criteria:

  • Segmental vitiligo.
  • Stable vitiligo.
  • History of endocrine disorders (growth hormone deficiency, thyroid disorders)
  • Growth disorders (Turner's syndrome, Klinefelter's syndrome)
  • Systemic diseases likely to affect growth (IBD, chronic renal failure)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMP dexamethasone 2 consecutive days per week in a dose of 0.1mg/kg/day for 3 months
Drug: Dexamethasone (0.1 mg/kg)
patients will receive oral mini pulse dexamethasone 2 fixed consecutive days per week in a dose of 0.1mg/kg/day for a period of 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of dexamethasone in pediatric active non segmental vitiligo
Time Frame: 3 months
Vitiligo signs of activity score (VSAS) will be evaluated and compared to baseline values. This scoring system ranges between (0-15). Zero means complete absence of clinical signs of activity. A decrease in the score at the end of the study compared to baseline values is considered an improvement (better outcome).
3 months
The effect of drug on bone age
Time Frame: 6 months
Plain Xray left hand and wrist will be done 3 months after stoppage of drug and compared to baseline Xray.
6 months
The effect of drug on linear growth
Time Frame: 6 months
The height of patients will be measured at baseline, at the end of treatment period and 3 months after stoppage of treatment. Height measurements will be done using a stadiometer and carefully read to the nearest 0.1 cm then height will be plotted on the WHO z-score growth charts.
6 months
The effect of drug on weight gain
Time Frame: 6 months
Weight will be measured at baseline, at the end of treatment period and 3 months after stoppage of the drug. Weight will be measured using a digital scale and will be recorded to the nearest 0.1kg then measurements will be plotted on WHO z score growth charts.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of drug on HBA1C
Time Frame: 3 months
HBA1c will be measured at the end of treatment period and compared to baseline values.
3 months
The incidence of adrenal suppression
Time Frame: 3 months
Cortisol am and ACTH am will be measured at the end of treatment period and compared to baseline values
3 months
Incidence of patient reported corticosteroid side effects
Time Frame: 3 months
patients will be followed up monthly during their treatment period, parents and patients will be questioned about the appearance of any of the following symptoms nausea, vomiting, epigastric pain, heart burn, increased appetite, weight gain and sleep disturbances.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMPpedvitiligo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I will share the deidentified data sheet of the results of the trial

IPD Sharing Time Frame

1 month after paper publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitiligo

Clinical Trials on Dexamethasone (0.1 mg/kg)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe