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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Autologous mini punch grafting

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Alsayed Alrashidy, MD; Phone Number: +201024524412; Email: mahaalrashidy87@yahoo.com
• Study Contact Backup: Name: I

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Medicine
    • Contact: Maha Alrashidy, MD; Phone Number: +201024524412; Email: mahaalrashidy87@yahoo.com
    • Contact: Carmen Ibrahiem farid amin, Ph.D; Phone Number: +201222966670; Email: carmen271173@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: 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
Experimental: 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	Procedure: 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
Experimental: 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of repigmentation and signs of reactivation	assessment of repigmentation will be performed by two blinded dermatologists using a 5-point scale ;grade 0(no repigmentation),grade 1(1%-5%),grade 2(6%-25%),grade3(26%-50%),grade4(51%-75%),grade5(76%-100%)	9 months
Evaluation of type, pattern and extent of re pigmentation	serial photography will be done to evaluate type, pattern and extent of re pigmentation	9 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Carmen brahiem farid amin, Ph.D, Assistant professor of dermatology faculty of medicine .University of Alexandria; Study Director: Ai Ahmed fouad El Eriny, Ph.D, Professor of dermatology faculty of medicine .University of Alexandria; Study Director: Eman Hamed El Morsy, Ph.D, Professor of dermatology faculty of medicine .University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: topical treatment; vitiligo; mini punch grafting; oral mini pulse steroids
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: Mahaderma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No