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Not yet recruiting NCT06974669

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

No phase Interventional Vitiligo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oral steroid-dexamethasone, non cultured epidermal suspension.
Who it may be relevant to
Registry conditions: Vitiligo. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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.

Overview

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

Interventions

  • Drug 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
  • Procedure non cultured epidermal suspension
    this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms

Primary outcome measures

  • comparing percent change in pigmentation in both arms [Time frame: 3 months]
  • comparing percent change in surface area in both arms [Time frame: 3 months]
Secondary outcome measures (1)
  • comparing physician global assessment in both arms [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Dermatology Department, Cairo University Hospitals — Giza

Identifiers

NCT: NCT06974669 · VS-OMP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗