The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cultured Epidermal Cell Suspension (NCES) in Cases With Stable Segmental and Non-acral Vitiligo.

ConditionVitiligo
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorCairo University

About this trial

The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. The main questions it aims to answer are:

* Does adding mini-oral pulse steroid therapy reduce the development of a perilesional halo after NCES surgery? * Does the addition of steroids improve the degree of repigmentation and overall treatment outcomes in vitiligo lesions?

Researchers will compare NCES surgery with mini-oral pulse steroids to NCES surgery alone to determine whether the steroid therapy improves surgical outcomes.

Participants will:

* Undergo NCES vitiligo surgery for stable segmental or non-acral vitiligo lesions. * Be randomly assigned to receive either surgery alone or surgery plus low-dose oral mini-pulse dexamethasone therapy. * Attend follow-up visits and clinical assessments for approximately 4 months. * Receive excimer laser sessions twice weekly after healing and have standardized photographs and scoring assessments to evaluate repigmentation.

Eligibility criteria

Qualifiers

Patients with segmental vitiligo lesions that are not responsive to conventional treatment.

Patients with non-Acral vitiligo lesions that are not responsive to conventional treatment and on sites known to be responsive to surgery, like the face and trunk.

Stability for ≥ 1 year.

Age ≥12 years.

Disqualifiers

Acral vitiligo.

Segmental vitiligo lesions that are responsive to conventional treatment.

Non acral vitiligo lesions on sites that are knowingly not responsive to surgery, like knees and elbows.

Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges, hypochromia, depigmentation of previously pigmented areas or koebnerization in < 1 year.

Trial design

Treatments tested in this trial

  • Non-cultured epidermal cell suspension (NCES) surgery
  • Oral mini pulse
  • Excimer Sessions

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators