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

Not Applicable

Not yet recruiting

• Conditions: Vitiligo
• Interventions: Drug: oral steroid-dexamethasone; Procedure: non cultured epidermal suspension

• Registration Number: NCT06974669
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study Start: 2025-05-12
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-08-15
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period	oral steroid-dexamethasone	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
Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period	non cultured epidermal suspension	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
Vitiligo surgery without mini-oral pulse steroid therapy	non cultured epidermal suspension	this group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids.

Primary Outcome Measures

Name	Time	Method
comparing percent change in pigmentation in both arms	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.
comparing percent change in surface area in both arms	3 months	• Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique.

Secondary Outcome Measures

Name	Time	Method
comparing physician global assessment in both arms	3 months	• Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy

Trial Locations

Locations (1)

Dermatology Department, Cairo University Hospitals; 🇪🇬 Giza, Egypt