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

NCT04765826 | Unknown DMC

• 1 other identifier: Mahaderma
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

vitiligo; mini punch grafting; oral mini pulse steroids; topical treatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

high dose oral steroids

EXPERIMENTAL

(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

low dose oral steroids

EXPERIMENTAL

(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

topical treatment

EXPERIMENTAL

(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

Interventions

Autologous mini punch grafting 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

high dose oral steroids; low dose oral steroids; topical treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Absence of new lesions or extension of preexisting lesions prior to presentation for the last 6 months.
• Absence of koebner phenomenon, confetti lesions or hypopigmented lesions, or lesions with ill-defined borders during this same time period.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria faculty of medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 DIRECTOR

Central Study Contacts

Maha Alsayed Alrashidy, MD

CONTACT

+201024524412; mahaalrashidy87@yahoo.com

I

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: January 25, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)