Comparison Between Systemic Steroids, Topical Steroids, or Calcineurin Inhibitors With Mini Punch Grafting in Treatment of Stable Non-segmental Vitiligo

NCT ID: NCT04765826

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2022-08-31

Brief Summary

The study to compare the outcomes of mini punch grafting in patients with resistant stable non-segmental vitiligo already on narrowband ultraviolet B and receiving either no additional medication , systemic mini pulse (high and low dose) steroids, topical superpotent steroids once every other day , or daily tacrolimus ointment .in terms of the extent of repigmentation , frequency of reactivation and side effects.

Detailed Description

Vitiligo, a depigmenting skin disorder, is characterized by the selective loss of melanocytes, which in turn leads to pigment dilution or loss in the affected areas of the skin. Vitiligo reportedly affects 0.5% to 2% of the world's population, without a clear preference for race or sex. Vitiligo is clinically classified into two main clinical patterns: nonsegmental and segmental. Dermoscopy facilitates the diagnosis of vitiligo .and can be used to assess the evolution of the stage of the disease (stability, progression, repigmentation) as well as the response to treatment. Stability of vitiligo refers to the arrest of disease activity, in terms of the absence of new lesions, no extension of pre-existing lesions, and an absence of Koebner's phenomenon among other features. The duration of stability is a matter of debate, ranging from as little as six months to as long as two years Recent studies have indicated that skin lesions observed in vitiligo tend to recur in the same places where they were found before treatment. This phenomenon is explained by the presence of a recently described subset of memory T cells known as cluster of differentiation( CD8 + )resident memory T cells (TRM) in lesional vitiligo patient skin and a role in disease maintenance and relapse following treatment has been suggested. Thus, the use of immunosuppressants/modulators could ameliorate their activity hence playing a role in stabilizing or treating the disease. . They could also improve the results of surgical options utilized in stable vitiligo refractory to medical treatments including tissue grafts (full-thickness punch, split-thickness, and suction blister grafts), cellular grafts (autologous melanocyte cultures and non-cultured epidermal cellular grafts. In addition to cultured epidermal suspensions and hair follicle transplantation These immune-modulators include: systemic and topical corticosteroids, a topical calcineurin inhibitor, and phototherapy

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high dose oral steroids

(20 patients) will receive high dose oral mini pulse steroids (dexamethasone 5 mg on two consecutive weekly days for 3 months).

Group Type: EXPERIMENTAL

Autologous mini punch grafting

Intervention Type: PROCEDURE

All the medications will be administered for 3 months prior to surgery in addition to twice-weekly NB-UVB sessions following its standard protocol.and all patients will continue the treatment till the end of the follow up period Only stable non-responsive or poorly responsive patients (<25% according to VASI score vitiligo area severity index) and image J measurement during the 1st 3 months phase will be included.

. Chosen lesions in all included patient's groups will undergo mini-punch grafting Mini punch grafting: Skin grafts will be harvested from the anesthetized (local infiltration of 2% lignocaine) donor site (the anterolateral aspect of the thigh, using 1mm sterile disposable punches. The grafts obtained will be placed in the slots made by removing the vitiliginous skin using 1mm punches at the recipient site

low dose oral steroids

(20 patients) will receive low dose oral mini pulse steroids (2.5mg dexamethasone on two consecutive weekly days for 3 months

Group Type: EXPERIMENTAL

Autologous mini punch grafting

Intervention Type: PROCEDURE

All the medications will be administered for 3 months prior to surgery in addition to twice-weekly NB-UVB sessions following its standard protocol.and all patients will continue the treatment till the end of the follow up period Only stable non-responsive or poorly responsive patients (<25% according to VASI score vitiligo area severity index) and image J measurement during the 1st 3 months phase will be included.

. Chosen lesions in all included patient's groups will undergo mini-punch grafting Mini punch grafting: Skin grafts will be harvested from the anesthetized (local infiltration of 2% lignocaine) donor site (the anterolateral aspect of the thigh, using 1mm sterile disposable punches. The grafts obtained will be placed in the slots made by removing the vitiliginous skin using 1mm punches at the recipient site

topical treatment

(20 patients) chosen lesions of comparable size and location in each patient in this group will receive either; super potent topical steroids once every other day, Tacrolimus ointment twice daily for 3 months, or nothing to serve as a control.

Group Type: EXPERIMENTAL

Autologous mini punch grafting

Intervention Type: PROCEDURE

All the medications will be administered for 3 months prior to surgery in addition to twice-weekly NB-UVB sessions following its standard protocol.and all patients will continue the treatment till the end of the follow up period Only stable non-responsive or poorly responsive patients (<25% according to VASI score vitiligo area severity index) and image J measurement during the 1st 3 months phase will be included.

. Chosen lesions in all included patient's groups will undergo mini-punch grafting Mini punch grafting: Skin grafts will be harvested from the anesthetized (local infiltration of 2% lignocaine) donor site (the anterolateral aspect of the thigh, using 1mm sterile disposable punches. The grafts obtained will be placed in the slots made by removing the vitiliginous skin using 1mm punches at the recipient site

Interventions

Autologous mini punch grafting

All the medications will be administered for 3 months prior to surgery in addition to twice-weekly NB-UVB sessions following its standard protocol.and all patients will continue the treatment till the end of the follow up period Only stable non-responsive or poorly responsive patients (<25% according to VASI score vitiligo area severity index) and image J measurement during the 1st 3 months phase will be included.

. Chosen lesions in all included patient's groups will undergo mini-punch grafting Mini punch grafting: Skin grafts will be harvested from the anesthetized (local infiltration of 2% lignocaine) donor site (the anterolateral aspect of the thigh, using 1mm sterile disposable punches. The grafts obtained will be placed in the slots made by removing the vitiliginous skin using 1mm punches at the recipient site

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients of either gender aged more than 18 years old, with stable resistant non-segmental vitiligo will be included.

Stability is defined in terms of:

1. Absence of new lesions or extension of preexisting lesions prior to presentation for the last 6 months.

2. Absence of koebner phenomenon, confetti lesions or hypopigmented lesions, or lesions with ill-defined borders during this same time period.

3. Absence of activity signs by dermoscopic examination which includes :

• Ill-defined or trichrome border.
• Micro-Koebner's phenomenon.
• Tapioca sago appearance.
• Starburst appearance.
• Comet tail appearance.
• Altered pigment network. Resistance to treatment is defined in terms of not responding or those responding poorly to administered treatment (<25% repigmentation according to VASI score) over the last 3 months, especially in patients having lesions on glabrous skin or those with lesions showing leukotrichia.

Exclusion Criteria

Cases of active, the progressive disease having any of the features of activity listed above during the last 6 months.

Patients with regressive disease showing evidence of repigmentation under administered therapy.

Patients with segmental vitiligo or vitiligo affecting more than 70% body surface area.

Patients with associated autoimmune diseases or any other comorbidity. Patients with a tendency towards hypertrophic scars or keloid formation. Pregnant and breast-feeding females. Patients with psychological instability and unrealistic expectations.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Maha

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmen brahiem farid amin, Ph.D

Role: STUDY_DIRECTOR

Assistant professor of dermatology faculty of medicine .University of Alexandria

Ai Ahmed fouad El Eriny, Ph.D

Role: STUDY_DIRECTOR

Professor of dermatology faculty of medicine .University of Alexandria

Eman Hamed El Morsy, Ph.D

Role: STUDY_DIRECTOR

Professor of dermatology faculty of medicine .University of Alexandria

Locations

Alexandria faculty of medicine

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maha Alsayed Alrashidy, MD

Role: CONTACT

mahaalrashidy87@yahoo.com

+201024524412

I

Role: CONTACT

Facility Contacts

Maha Alrashidy, MD

Role: primary

mahaalrashidy87@yahoo.com

+201024524412

Carmen Ibrahiem farid amin, Ph.D

Role: backup

carmen271173@yahoo.com

+201222966670

Other Identifiers

Mahaderma

Identifier Type: -

Identifier Source: org_study_id