Oral Mini Pulse Dexamethasone in Pediatric Vitiligo

NCT07353801 | Active Not Recruiting Phase 4

• 1 other identifier: OMPpedvitiligo
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo

Keywords

oral mini pulse; vitiligo; pediatric; dexamethasone

Outcome Measures

Primary Outcomes (4)

• The efficacy of dexamethasone in pediatric active non segmental vitiligo

  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

  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

  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

  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 Outcomes (3)

• The effect of drug on HBA1C

  3 months

• The incidence of adrenal suppression

  3 months

• Incidence of patient reported corticosteroid side effects

  3 months

Study Arms (1)

OMP dexamethasone 2 consecutive days per week in a dose of 0.1mg/kg/day for 3 months

EXPERIMENTAL

Drug: Dexamethasone (0.1 mg/kg)

Interventions

Dexamethasone (0.1 mg/kg) DRUG

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

OMP dexamethasone 2 consecutive days per week in a dose of 0.1mg/kg/day for 3 months

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (9)

• Nicolaidou E, Mastraftsi S, Tzanetakou V, Rigopoulos D. Childhood Vitiligo. Am J Clin Dermatol. 2019 Aug;20(4):515-526. doi: 10.1007/s40257-019-00430-0.

  PMID: 30911977 BACKGROUND

• Lobato-Berezo A, March-Rodriguez A, Grimalt R, Rodriguez-Lomba E, Seto-Torrent N, Pujol RM, Ruiz-Villaverde R. Mini pulse corticosteroid therapy with oral dexamethasone for moderate to severe alopecia areata: A multicentric study. Dermatol Ther. 2022 Nov;35(11):e15806. doi: 10.1111/dth.15806. Epub 2022 Sep 16.

  PMID: 36070222 BACKGROUND

• Sinha P, Sood A, Mukherjee B, Sinha A, Baveja S, Pathania V. Study to evaluate effect of oral mini pulse corticosteroid therapy for unstable vitiligo on hypothalamic pituitary adrenal axis suppression. Med J Armed Forces India. 2024 Dec;80(Suppl 1):S66-S72. doi: 10.1016/j.mjafi.2022.08.010. Epub 2022 Oct 22.

  PMID: 39734899 BACKGROUND

• Majid I, Masood Q, Hassan I, Khan D, Chisti M. Childhood vitiligo: response to methylprednisolone oral minipulse therapy and topical fluticasone combination. Indian J Dermatol. 2009;54(2):124-7. doi: 10.4103/0019-5154.53185.

  PMID: 20101306 BACKGROUND

• Radakovic-Fijan S, Furnsinn-Friedl AM, Honigsmann H, Tanew A. Oral dexamethasone pulse treatment for vitiligo. J Am Acad Dermatol. 2001 May;44(5):814-7. doi: 10.1067/mjd.2001.113475.

  PMID: 11312430 BACKGROUND

• Kanwar AJ, Mahajan R, Parsad D. Low-dose oral mini-pulse dexamethasone therapy in progressive unstable vitiligo. J Cutan Med Surg. 2013 Jul-Aug;17(4):259-68. doi: 10.2310/7750.2013.12053.

  PMID: 23815959 BACKGROUND

• Kanwar AJ, Dhar S, Dawn G. Oral minipulse therapy in vitiligo. Dermatology. 1995;190(3):251-2. doi: 10.1159/000246705. No abstract available.

  PMID: 7599392 BACKGROUND

• Pasricha JS, Khaitan BK. Oral mini-pulse therapy with betamethasone in vitiligo patients having extensive or fast-spreading disease. Int J Dermatol. 1993 Oct;32(10):753-7. doi: 10.1111/j.1365-4362.1993.tb02754.x.

  PMID: 8225724 BACKGROUND

• El Ghazaly, G. M., Albalat, W. M. and El Ghareeb, M. I. (2021) 'Use of oral mini pulse dexamethasone in vitiligo patients: Review article', Egyptian Journal of Hospital Medicine, 85(2), pp. 3909-3911. doi: 10.21608/ejhm.2021.205395.

  BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor Dermatology department Cairo University

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 20, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 month after paper publication

Locations

EG (1)