Oral Mini Pulse Dexamethasone in Pediatric Vitiligo

Cairo University (CU)

Status and phase

Enrolling

Phase 4

Conditions

Vitiligo

Treatments

Drug: Dexamethasone (0.1 mg/kg)

Study type

Interventional

Funder types

Other

Identifiers

NCT07353801

OMPpedvitiligo

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

4 to 9 years old

Volunteers

No Healthy Volunteers

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