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

NCT06974669 | Not Yet Recruiting DMC

• 1 other identifier: VS-OMP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitiligo

Keywords

vitiligo; surgery; mini-oral pulse steroid therapy; resistant

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (1)

• comparing physician global assessment in both arms

  3 months

Study Arms (2)

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

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.

Procedure: non cultured epidermal suspension

Interventions

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

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

non cultured epidermal suspension PROCEDURE

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

Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period; Vitiligo surgery without mini-oral pulse steroid therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology Department, Cairo University Hospitals

Giza, 12655, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr. Mogawer, MD, PhD

  Dermatology Department, Cairo University Hopsitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mogawer, MD, PhD

CONTACT

+20106815330; raniamogawer@kasralainy.edu.eg

Prof. Nanis Ragab, MD, PhD

CONTACT

+201227449161; nanisragab@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 12, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within 3 months and for 12 months after completion of the study
• Access Criteria: Controlled Access: Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal

Locations

EG (1)