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

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Autologous mini punch grafting
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, mini punch grafting, oral mini pulse steroids, topical treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexandria faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

high dose oral steroids

low dose oral steroids

topical treatment

Arm Description

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

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

(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.

Outcomes

Primary Outcome Measures

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%)
Evaluation of type, pattern and extent of re pigmentation
serial photography will be done to evaluate type, pattern and extent of re pigmentation

Secondary Outcome Measures

Full Information

First Posted
February 18, 2021
Last Updated
February 21, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04765826
Brief Title
Comparison Between Systemic Steroids, Topical Steroids, or Calcineurin Inhibitors With Mini Punch Grafting in Treatment of Stable Non-segmental Vitiligo
Official Title
Comparison Between Systemic Steroids, Topical Steroids, or Calcineurin Inhibitors With Mini Punch Grafting in Treatment of Stable Non-segmental Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
vitiligo, mini punch grafting, oral mini pulse steroids, topical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high dose oral steroids
Arm Type
Experimental
Arm Description
(20 patients) will receive high dose oral mini pulse steroids (dexamethasone 5 mg on two consecutive weekly days for 3 months).
Arm Title
low dose oral steroids
Arm Type
Experimental
Arm Description
(20 patients) will receive low dose oral mini pulse steroids (2.5mg dexamethasone on two consecutive weekly days for 3 months
Arm Title
topical treatment
Arm Type
Experimental
Arm Description
(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.
Intervention Type
Procedure
Intervention Name(s)
Autologous mini punch grafting
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of repigmentation and signs of reactivation
Description
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%)
Time Frame
9 months
Title
Evaluation of type, pattern and extent of re pigmentation
Description
serial photography will be done to evaluate type, pattern and extent of re pigmentation
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Alsayed Alrashidy, MD
Phone
+201024524412
Email
mahaalrashidy87@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
I
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen brahiem farid amin, Ph.D
Organizational Affiliation
Assistant professor of dermatology faculty of medicine .University of Alexandria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ai Ahmed fouad El Eriny, Ph.D
Organizational Affiliation
Professor of dermatology faculty of medicine .University of Alexandria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eman Hamed El Morsy, Ph.D
Organizational Affiliation
Professor of dermatology faculty of medicine .University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria faculty of medicine
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha Alrashidy, MD
Phone
+201024524412
Email
mahaalrashidy87@yahoo.com
First Name & Middle Initial & Last Name & Degree
Carmen Ibrahiem farid amin, Ph.D
Phone
+201222966670
Email
carmen271173@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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