The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo

NCT ID: NCT06974669

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2025-10-01

Brief Summary

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Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo

Detailed Description

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Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period

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

Group Type ACTIVE_COMPARATOR

oral steroid-dexamethasone

Intervention Type DRUG

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 suspension

Intervention Type PROCEDURE

this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms

Vitiligo surgery without mini-oral pulse steroid therapy

this group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids.

Group Type ACTIVE_COMPARATOR

non cultured epidermal suspension

Intervention Type PROCEDURE

this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms

Interventions

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oral steroid-dexamethasone

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

Intervention Type DRUG

non cultured epidermal suspension

this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rania Mogawer

Lecturer of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Mogawer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Department, Cairo University Hopsitals

Locations

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Dermatology Department, Cairo University Hospitals

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Dr. Mogawer, MD, PhD

Role: CONTACT

+20106815330

Prof. Nanis Ragab, MD, PhD

Role: CONTACT

+201227449161

Facility Contacts

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Rania Mogawer

Role: primary

106816339

Other Identifiers

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VS-OMP

Identifier Type: -

Identifier Source: org_study_id

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