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