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

February 21, 2021 updated by: Maha, Alexandria University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: I

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of repigmentation and signs of reactivation
Time Frame: 9 months

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
Time Frame: 9 months
serial photography will be done to evaluate type, pattern and extent of re pigmentation
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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