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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03158675
• Other study ID #: FCO2L
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: July 2019

Study information

• Verified date: November 2018
• Source: Assiut University
• Contact: Dalia Attalla, prof
• Phone: 00201005677229
• Email: daliaattallah[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

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.

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

Bayoumi W, Fontas E, Sillard L, Le Duff F, Ortonne JP, Bahadoran P, Lacour JP, Passeron T. Effect of a preceding laser dermabrasion on the outcome of combined therapy with narrowband ultraviolet B and potent topical steroids for treating nonsegmental vitiligo in resistant localizations. Br J Dermatol. 2012 Jan;166(1):208-11. doi: 10.1111/j.1365-2133.2011.10564.x. Epub 2011 Nov 17. — View Citation

Beachkofsky TM, Henning JS, Hivnor CM. Induction of de novo hair regeneration in scars after fractionated carbon dioxide laser therapy in three patients. Dermatol Surg. 2011 Sep;37(9):1365-8. doi: 10.1111/j.1524-4725.2011.01934.x. Epub 2011 Apr 14. — View Citation

Benzekri L, Ezzedine K, Gauthier Y. Vitiligo Potential Repigmentation Index: a simple clinical score that might predict the ability of vitiligo lesions to repigment under therapy. Br J Dermatol. 2013 May;168(5):1143-6. doi: 10.1111/bjd.12147. Epub 2013 Mar 7. — View Citation

Cui J, Shen LY, Wang GC. Role of hair follicles in the repigmentation of vitiligo. J Invest Dermatol. 1991 Sep;97(3):410-6. — View Citation

Dillon AB, Sideris A, Hadi A, Elbuluk N. Advances in Vitiligo: An Update on Medical and Surgical Treatments. J Clin Aesthet Dermatol. 2017 Jan;10(1):15-28. Epub 2017 Jan 1. Review. — View Citation

Ezzedine K, Lim HW, Suzuki T, Katayama I, Hamzavi I, Lan CC, Goh BK, Anbar T, Silva de Castro C, Lee AY, Parsad D, van Geel N, Le Poole IC, Oiso N, Benzekri L, Spritz R, Gauthier Y, Hann SK, Picardo M, Taieb A; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012 May;25(3):E1-13. doi: 10.1111/j.1755-148X.2012.00997.x. — View Citation

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. — View Citation

Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. — View Citation

Ito M, Yang Z, Andl T, Cui C, Kim N, Millar SE, Cotsarelis G. Wnt-dependent de novo hair follicle regeneration in adult mouse skin after wounding. Nature. 2007 May 17;447(7142):316-20. — View Citation

Li L, Wu Y, Li L, Sun Y, Qiu L, Gao XH, Chen HD. Triple combination treatment with fractional CO2 laser plus topical betamethasone solution and narrowband ultraviolet B for refractory vitiligo: a prospective, randomized half-body, comparative study. Dermatol Ther. 2015 May-Jun;28(3):131-4. doi: 10.1111/dth.12202. Epub 2015 Mar 5. — View Citation

Mulekar SV, Isedeh P. Surgical interventions for vitiligo: an evidence-based review. Br J Dermatol. 2013 Oct;169 Suppl 3:57-66. doi: 10.1111/bjd.12532. Review. — View Citation

Salman A, Kurt E, Topcuoglu V, Demircay Z. Social Anxiety and Quality of Life in Vitiligo and Acne Patients with Facial Involvement: A Cross-Sectional Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):305-11. doi: 10.1007/s40257-016-0172-x. — View Citation

Vachiramon V, Chaiyabutr C, Rattanaumpawan P, Kanokrungsee S. Effects of a preceding fractional carbon dioxide laser on the outcome of combined local narrowband ultraviolet B and topical steroids in patients with vitiligo in difficult-to-treat areas. Lasers Surg Med. 2016 Feb;48(2):197-202. doi: 10.1002/lsm.22389. Epub 2015 Jul 14. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	Scoring system of repigmentation	G0,<25% repigmentation (poor); G1,25-50% repigmentation (fair); G2,50-75% repigmentation (good); G3,>75% repigmentation (excellent).	4 months
Secondary	Patient satisfaction	0 - not satisfactory; to 10 - very satisfactory	4 months