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

Cairo University (CU)

Status

Not yet enrolling

Conditions

Vitiligo

Treatments

Procedure: non cultured epidermal suspension

Drug: oral steroid-dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT06974669

VS-OMP

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Drug: oral steroid-dexamethasone

Procedure: non cultured epidermal suspension

Vitiligo surgery without mini-oral pulse steroid therapy

Active Comparator group

Description:

this group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids.

Treatment:

Procedure: non cultured epidermal suspension