VitiligoPhase 4NCT07353801
Oral Mini Pulse Dexamethasone in Pediatric Vitiligo
A Phase 4 study testing Dexamethasone (0.1 mg/kg) in people with Vitiligo, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Dexamethasone (0.1 mg/kg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2026to 28 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology Outpatient Clinic, Kasr al Ainy Teaching Hospital, Cairo University
Cairo
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Dexamethasone (0.1 mg/kg)
- Keywords
- oral mini pulse, vitiligo, pediatric, dexamethasone
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| OMP dexamethasone 2 consecutive days per week in a dose of 0.1mg/kg/day for 3 months | Experimental | Not described Receives: Drug: Dexamethasone (0.1 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
The effect of drug on HBA1C
HBA1c will be measured at the end of treatment period and compared to baseline values.
Measured: 3 months
The incidence of adrenal suppression
Cortisol am and ACTH am will be measured at the end of treatment period and compared to baseline values
Measured: 3 months
Incidence of patient reported corticosteroid side effects
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start28 Feb 2026
- Primary completion15 Jul 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanis Aleem Abdul Moneim Ragab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353801
- Sponsor's protocol ID
- OMPpedvitiligo
- Status last verified
- May 2026
- First submitted
- 5 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share the deidentified data sheet of the results of the trial
Publications
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.
PubMed 30911977Lobato-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.
PubMed 36070222Sinha 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.
PubMed 39734899Majid 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.
PubMed 20101306Radakovic-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.
PubMed 11312430Kanwar 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.
PubMed 23815959Kanwar AJ, Dhar S, Dawn G. Oral minipulse therapy in vitiligo. Dermatology. 1995;190(3):251-2. doi: 10.1159/000246705. No abstract available.
PubMed 7599392Pasricha 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.
PubMed 8225724El 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Oral Mini-pulse Dexamethasone in Active Non-segmental Vitiligo Within the Pediatric Age Group
- ClinicalTrials.gov ID
- NCT07353801
- Acronym / sponsor ID
- OMPpedvitiligo
- Conditions
- Vitiligo
- Keywords
- oral mini pulse, vitiligo, pediatric, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | OMP dexamethasone 2 consecutive days per week in a dose of 0.1mg/kg/day for 3 months |
Primary outcome
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).
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.
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.
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.
3 secondary outcomes
The effect of drug on HBA1C
Time frame: 3 months
The incidence of adrenal suppression
Time frame: 3 months
Incidence of patient reported corticosteroid side effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 30911977Nicolaidou 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.
- Background: PubMed 36070222Lobato-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.
- Background: PubMed 39734899Sinha 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.
- Background: PubMed 20101306Majid 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.
- Background: PubMed 11312430Radakovic-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.
- Background: PubMed 23815959Kanwar 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.
- Background: PubMed 7599392Kanwar AJ, Dhar S, Dawn G. Oral minipulse therapy in vitiligo. Dermatology. 1995;190(3):251-2. doi: 10.1159/000246705. No abstract available.
- Background: PubMed 8225724Pasricha 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.
- BackgroundEl 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.
- Individual participant dataSharing planned: Yes. I will share the deidentified data sheet of the results of the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone (0.1 mg/kg) in people with Vitiligo, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of dexamethasone in pediatric active non segmental vitiligo (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07353801, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.