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NCT Number: NCT06974669

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

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

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Department, Cairo University Hospitals

Giza, 12655, Egypt

Location contact

Rania Mogawer

CONTACT

106816339

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral steroid-dexamethasone

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

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. comparing physician global assessment in both arms

    Time frame: 3 months

    • Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Mogawer, MD, PhD

CONTACT

[email protected]

+20106815330

Prof. Nanis Ragab, MD, PhD

CONTACT

[email protected]

+201227449161

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Acronym: NCES

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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