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

November 26, 2018 updated by: MUAAhmed, Assiut University

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • 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.

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

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional co2 laser&topical steroid

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.
Procedure: fractional carbon dioxide(CO2) laser
-Fractional CO2 laser: Laser sessions will be performed at half month interval and it will be used with a wave length of 10,600nm.
Other Names:
  • Laser
Drug: Topical corticosteroid
Topical corticosteroid will be applyed twice weekly on both sides for 4 months.
Other Names:
  • Topical steroid
Radiation: Ultraviolet B narrow band
Ultraviolet B narrow band will be performed (wave length ranged from 300 to 320nm).The sessions will be performed twice weekly for 4 months.
Other Names:
  • Phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VASI scor-Vitiligo Area and Severity Index:
Time Frame: 4 months
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scoring system of repigmentation
Time Frame: 4 months
  • G0,<25% repigmentation (poor)
  • G1,25-50% repigmentation (fair)
  • G2,50-75% repigmentation (good)
  • G3,>75% repigmentation (excellent).
4 months
Patient satisfaction
Time Frame: 4 months
  • 0 - not satisfactory
  • to 10 - very satisfactory
4 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Muna Abdullah, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

May 13, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCO2L

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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