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Fractional Carbon Dioxide Laser,Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fractional carbon dioxide(CO2) laser
Topical corticosteroid
Ultraviolet B narrow band
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring fractional co2 laser, topical steroid,UVB narrow band

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient age ≥ 14 years old.
  • Any sex

Exclusion Criteria:

  • Patients less than 14 years old.
  • Patients with new, spreading lesions of vitiligo within the preceding 6 months.
  • Pregnant female patients.
  • Patients with history of keloid formation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fractional co2 laser&topical steroid

    Arm Description

    participant will be compared with one side of the body to the ather side. Intervention: -Procedure: Fractional carbon dioxide laser. -Drug: Topical corticosteroid. -Radiation: Ultraviolet B narrow band.

    Outcomes

    Primary Outcome Measures

    VASI scor-Vitiligo Area and Severity Index:
    Vitiligo Area and Severity Index (VASI) One hand unit ,which encompasses the palm plus the volar surface of all the digits,is approximately 1% of the total body surface area and is used as a guide to estimate the baseline percentage of vitiligo involvement in each body region.The body is divided into five separate and mutually exclusive regions: hands ,upper extremities (excluding hands),trunk,lower extremities(excluding feet),and feet.The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities.The extent of residual depigmentation is expressed by the following percentages:0,10%,25%,50%,75%,90%,or100%.At 100% depigmentation,no pigment is present; at 90%,specks of pigment is present; at75%,the depigmented area exceeds the pigmented area; at50%,the depigmented and pigmented area are equal; at 25%,the pigmented area exceeds the depigmented area; at10% only specks of depigmentation are present.

    Secondary Outcome Measures

    Scoring system of repigmentation
    G0,<25% repigmentation (poor) G1,25-50% repigmentation (fair) G2,50-75% repigmentation (good) G3,>75% repigmentation (excellent).
    Patient satisfaction
    0 - not satisfactory to 10 - very satisfactory

    Full Information

    First Posted
    May 13, 2017
    Last Updated
    November 26, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03158675
    Brief Title
    Fractional Carbon Dioxide Laser,Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo
    Official Title
    Fractional Carbon Dioxide Laser Combined With Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Vitiligo is an acquired disease with a variable course. It is characterized clinically by well-defined depigmented macules or patches thought to occur secondary to melanocyte dysfunction and loss. it is the most common depigmentation disorder, affecting approximately 0.5 to 2.0 percent of the population and has no predilection for gender or race .
    Detailed Description
    Vitiligo is primarily a clinical diagnosis without the need for diagnostic tools. It classified into three types: segmental vitiligo , nonsegmental vitiligo , and unclassifiable vitiligo . Onset and disease course may vary by subtype .Although the disease is typically asymptomatic and non-fatal; the profound cosmetic disfigurement it produces has a significant negative impact on the patient's quality of life . Vitiligo occurs due to a complex interaction among genetic, environmental and immunologic factors. This ultimately leads to melanocyte damage resulting characteristic depigmented lesions. Conventional vitiligo treatments include topical steroid, topical and oral immunomodulators and phototherapy. In spite of much advancement in pharmacotherapy, treatment for vitiligo still remains a challenge for physicians. Re-pigmentation of the lesions on the extremities or over bony prominences is particularly poor due to the reduced numbers of follicle-based melanocytes in these areas . Treatment of vitiligo with narrowband ultraviolet B light is an important component of the current standard of care.Narrowband ultraviolet B therapy or topical corticosteroid has long been used in vitiligo. However, the re-pigmentation is always transient and time-consuming . Using surgical therapies (Dermabrasion) may increase the rate of re-pigmentation or erbium-doped yttrium aluminum garnet laser to stimulate melanocyte stem cells and enhance drug absorption and autoinoculation of melanocytes from the margin, but create wounds that take a longer time to heal . In addition to being costly and time consuming, special training, staff, and equipment are needed in order to perform the procedures. Fractional carbon dioxide lasers, originally developed for tissue rejuvenation and scar remodeling. Recently, it has been used in the treatment of vitiligo. The newly developed fractional carbon dioxide laser does not ablate the entire epidermis, leaving intact skin between coagulated necrotic columns. It decreases risk of potential side effects and minimizes duration of sick leave. Several mechanisms may contribute to explain the improvement of Vitiligo after fractional carbon dioxide laser sessions. Firstly, wounding therapies may regenerate de novo hair follicles by Wnt-dependant pathway .Moreover the role of hair follicles in the repigmentation of Vitiligo is longstanding knowledge . Secondly, wounding therapies and fractional wounding-therapies may increase the penetration and the well-known efficiency of ultraviolet-radiation. Thirdly, they may induce the activation, proliferation and migration of melanoblasts from the border areas or differentiation of stem cells from the dermis of lesions by initiating propigmenting cytokinic inflammatory cascades . Adding fractional carbon dioxide laser treatment to the conventional therapies of vitiligo may improve repigmentation rate as well as patient satisfaction . Aim of the Work : To evaluate the use of fractional Co2 laser combined with topical corticosteroid and ultraviolet B narrow band( UVB-NB) in treatment of stable vitiligo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitiligo
    Keywords
    fractional co2 laser, topical steroid,UVB narrow band

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    • Methods:- -In each patient: The lesions on one side of the body will be randomly allocated to group A, and the lesions on the other side to group B. Group A: will be treated with fractional CO2 laser combined with topical corticosteroid and UVB-NB. Group B: will be treated with topical corticosteroid and UVB-NB.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fractional co2 laser&topical steroid
    Arm Type
    Experimental
    Arm Description
    participant will be compared with one side of the body to the ather side. Intervention: -Procedure: Fractional carbon dioxide laser. -Drug: Topical corticosteroid. -Radiation: Ultraviolet B narrow band.
    Intervention Type
    Procedure
    Intervention Name(s)
    fractional carbon dioxide(CO2) laser
    Other Intervention Name(s)
    Laser
    Intervention Description
    -Fractional CO2 laser: Laser sessions will be performed at half month interval and it will be used with a wave length of 10,600nm.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical corticosteroid
    Other Intervention Name(s)
    Topical steroid
    Intervention Description
    Topical corticosteroid will be applyed twice weekly on both sides for 4 months.
    Intervention Type
    Radiation
    Intervention Name(s)
    Ultraviolet B narrow band
    Other Intervention Name(s)
    Phototherapy
    Intervention Description
    Ultraviolet B narrow band will be performed (wave length ranged from 300 to 320nm).The sessions will be performed twice weekly for 4 months.
    Primary Outcome Measure Information:
    Title
    VASI scor-Vitiligo Area and Severity Index:
    Description
    Vitiligo Area and Severity Index (VASI) One hand unit ,which encompasses the palm plus the volar surface of all the digits,is approximately 1% of the total body surface area and is used as a guide to estimate the baseline percentage of vitiligo involvement in each body region.The body is divided into five separate and mutually exclusive regions: hands ,upper extremities (excluding hands),trunk,lower extremities(excluding feet),and feet.The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities.The extent of residual depigmentation is expressed by the following percentages:0,10%,25%,50%,75%,90%,or100%.At 100% depigmentation,no pigment is present; at 90%,specks of pigment is present; at75%,the depigmented area exceeds the pigmented area; at50%,the depigmented and pigmented area are equal; at 25%,the pigmented area exceeds the depigmented area; at10% only specks of depigmentation are present.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Scoring system of repigmentation
    Description
    G0,<25% repigmentation (poor) G1,25-50% repigmentation (fair) G2,50-75% repigmentation (good) G3,>75% repigmentation (excellent).
    Time Frame
    4 months
    Title
    Patient satisfaction
    Description
    0 - not satisfactory to 10 - very satisfactory
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient age ≥ 14 years old. Any sex Exclusion Criteria: Patients less than 14 years old. Patients with new, spreading lesions of vitiligo within the preceding 6 months. Pregnant female patients. Patients with history of keloid formation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalia Attalla, prof
    Phone
    00201005677229
    Email
    daliaattallah@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doaa Abou-Taleb, Dr
    Phone
    00201001463937
    Email
    Dodda_aboutaleb@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muna Abdullah
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    21824124
    Citation
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    Fractional Carbon Dioxide Laser,Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo

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