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

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ClinicalTrials.gov Identifier: NCT03158675
Recruitment Status : Not yet recruiting
First Posted : May 18, 2017
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
MUAAhmed, Assiut University

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 .

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: fractional carbon dioxide(CO2) laser Drug: Topical corticosteroid Radiation: Ultraviolet B narrow band Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Fractional Carbon Dioxide Laser Combined With Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo.
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Vitiligo

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 Name: Laser

Drug: Topical corticosteroid
Topical corticosteroid will be applyed twice weekly on both sides for 4 months.
Other Name: 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 Name: Phototherapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Patient satisfaction [ Time Frame: 4 months ]
    • 0 - not satisfactory
    • to 10 - very satisfactory



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158675


Contacts
Contact: Dalia Attalla, prof 00201005677229 daliaattallah@yahoo.com
Contact: Doaa Abou-Taleb, Dr 00201001463937 Dodda_aboutaleb@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Muna Abdullah Assiut University

Publications:

Responsible Party: MUAAhmed, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03158675     History of Changes
Other Study ID Numbers: FCO2L
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MUAAhmed, Assiut University:
fractional co2 laser, topical steroid,UVB narrow band

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases