VitiligoNCESNCT06974669
The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo
A study testing oral steroid-dexamethasone and non cultured epidermal suspension in people with Vitiligo, run by Cairo University at 1 site in Egypt.
Trial summary
Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- oral steroid-dexamethasone and non cultured epidermal suspension
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment
- Stability for ≥ 1 year
- Age ≥18 years
- Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.
Who cannot join
- Non acral NSV responsive to conventional treatment modalities
- Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in < 1 year
- Age < 18 years.
- Pregnant females.
- Patients with hypertension, diabetes or tuberculosis
- Topical treatment in the past month and systemic treatment in the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Dermatology Department, Cairo University Hospitals
Giza, 12655
Rania Mogawer, 106816339
About this study
Official title: The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension in Stable Resistant Vitiligo: An Interventional Prospective Controlled Trial.
Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo
- Conditions
- Vitiligo
- Being tested
- oral steroid-dexamethasone, non cultured epidermal suspension
- Keywords
- vitiligo, surgery, mini-oral pulse steroid therapy, resistant
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral steroid-dexamethasoneDrug
this study is the first according to the best of our knowledge assessing the value of adding mini oral pulse steroid therapy to non cultured epidermal suspension in treatment of stable acral and difficult to treat vitiligo
non cultured epidermal suspensionProcedure or surgery
this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period | Active comparator | this group will receive oral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 2 weeks prior to NCES and for 4 weeks afterwards Receives: Drug: oral steroid-dexamethasone; Procedure: non cultured epidermal suspension |
| Vitiligo surgery without mini-oral pulse steroid therapy | Active comparator | this group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids. Receives: Procedure: non cultured epidermal suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing percent change in pigmentation in both arms
- Comparing percent change of pigmentation as per VESTA score after 3 months of treatment with NCES with and without mini oral pulse steroids.
Measured: 3 months
comparing percent change in surface area in both arms
- Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique.
Measured: 3 months
Secondary outcomes (1)
comparing physician global assessment in both arms
- Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy
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 posted16 May 2025
- Study start12 May 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mogawer, Cairo University
- Investigators
- Dr. Mogawer, MD, PhD, Principal investigator, Dermatology Department, Cairo University Hopsitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974669
- Sponsor's protocol ID
- VS-OMP
- Acronym
- NCES
- Status last verified
- Apr 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' data that underlie reported results will be shared upon request, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension in Stable Resistant Vitiligo: An Interventional Prospective Controlled Trial.
- ClinicalTrials.gov ID
- NCT06974669
- Acronym / sponsor ID
- NCES / VS-OMP
- Conditions
- Vitiligo
- Keywords
- vitiligo, surgery, mini-oral pulse steroid therapy, resistant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 May 2025 (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.
Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period | Active comparator | Drug: oral steroid-dexamethasone, Procedure: non cultured epidermal suspensionthis group will receive oral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 2 weeks prior to NCES and for 4 weeks afterwards |
| Vitiligo surgery without mini-oral pulse steroid therapy | Active comparator | Procedure: non cultured epidermal suspensionthis group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment
- Stability for ≥ 1 year
- Age ≥18 years
- Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.
Key exclusion criteria (6 listed)
- Non acral NSV responsive to conventional treatment modalities
- Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in < 1 year
- Age < 18 years.
- Pregnant females.
- Patients with hypertension, diabetes or tuberculosis
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 |
|---|---|---|
| oral steroid-dexamethasonethis study is the first according to the best of our knowledge assessing the value of adding mini oral pulse steroid therapy to non cultured epidermal suspension in treatment of stable acral and difficult to treat vitiligo | Drug | Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period |
| non cultured epidermal suspensionthis is the best surgical technique for surgical treatment of vitiligo that would be done for both arms | Procedure or surgery | Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period, Vitiligo surgery without mini-oral pulse steroid therapy |
Primary outcome
comparing percent change in pigmentation in both arms
Time frame: 3 months
• Comparing percent change of pigmentation as per VESTA score after 3 months of treatment with NCES with and without mini oral pulse steroids.
comparing percent change in surface area in both arms
Time frame: 3 months
• Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique.
1 secondary outcome
comparing physician global assessment in both arms
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. Participants' data that underlie reported results will be shared upon request, after deidentification
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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.
Dr. Mogawer, MD, PhD principal investigator
Dermatology Department, Cairo University Hopsitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral steroid-dexamethasone and non cultured epidermal suspension 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 6 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: opening soon, as of the sponsor's last update on 16 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Mogawer, MD, PhD (+20106815330, raniamogawer@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing percent change in pigmentation in both arms (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.