Fractional Laser in Combination With UVB Therapy in Vitiligo Patients
NCT ID: NCT02290717
Last Updated: 2016-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-05-31
2015-11-30
Brief Summary
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Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment in combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB and topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective observer blinded randomised intra-patient controlled study.
Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are resistant to NB- UVB treatment after 3 to 6 months.
Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser abrasion, or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and topical steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will be given according to the standard treatment protocol of the SNIP and continued for at least 6 months. Two and 6 months after the laser treatment, the percentage of repigmentation of the lesions will be assessed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laser+fluticason+UVB
The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.
Fractional CO2 laser
NB-UVB therapy
NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.
Fluticasone Propionate Cream 0.05%
4 times a week (standard IPD protocol)
Laser+UVB
In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).
Fractional CO2 laser
NB-UVB therapy
NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.
UVB
As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2.
NB-UVB therapy
NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.
Interventions
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Fractional CO2 laser
NB-UVB therapy
NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.
Fluticasone Propionate Cream 0.05%
4 times a week (standard IPD protocol)
Eligibility Criteria
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Inclusion Criteria
* receiving NB- UVB treatment for 3 to 6 months
* Age \>18 years
* At least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm.
* Patient is willing and able to give written informed consent
Exclusion Criteria
* Recurrent HSV skin infections
* Hypertrophic scars
* Keloid
* Cardial insufficiency
* Patients who are pregnant or breast-feeding
* Patients not competent to understand what the procedures involved
* Patients with a personal history of melanoma or non-melanoma skin cancer
* Patients with atypical nevi.
18 Years
ALL
No
Sponsors
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Netherlands Institute for Pigment Disorders
OTHER
Responsible Party
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JELommerts
MSc MD
Locations
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Academic Medical Centre
Amsterdam, , Netherlands
Countries
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References
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Garg T, Chander R, Jain A. Combination of microdermabrasion and 5-fluorouracil to induce repigmentation in vitiligo: an observational study. Dermatol Surg. 2011 Dec;37(12):1763-6. doi: 10.1111/j.1524-4725.2011.02127.x. Epub 2011 Aug 11.
Shin J, Lee JS, Hann SK, Oh SH. Combination treatment by 10 600 nm ablative fractional carbon dioxide laser and narrowband ultraviolet B in refractory nonsegmental vitiligo: a prospective, randomized half-body comparative study. Br J Dermatol. 2012 Mar;166(3):658-61. doi: 10.1111/j.1365-2133.2011.10723.x. Epub 2012 Jan 19.
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.
Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.
Ongenae K, Van Geel N, De Schepper S, Naeyaert JM. Effect of vitiligo on self-reported health-related quality of life. Br J Dermatol. 2005 Jun;152(6):1165-72. doi: 10.1111/j.1365-2133.2005.06456.x.
Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
Drake LA, Dinehart SM, Farmer ER, Goltz RW, Graham GF, Hordinsky MK, Lewis CW, Pariser DM, Skouge JW, Turner ML, Webster SB, Whitaker DC, Lowery BJ, Nordlund JJ, Grimes PE, Halder RM, Minus HR. Guidelines of care for vitiligo. American Academy of Dermatology. J Am Acad Dermatol. 1996 Oct;35(4):620-6. doi: 10.1016/s0190-9622(96)90691-x. No abstract available.
Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. doi: 10.2165/00128071-200102030-00006.
Taieb A, Picardo M. Clinical practice. Vitiligo. N Engl J Med. 2009 Jan 8;360(2):160-9. doi: 10.1056/NEJMcp0804388. No abstract available.
Taieb A, Alomar A, Bohm M, Dell'anna ML, De Pase A, Eleftheriadou V, Ezzedine K, Gauthier Y, Gawkrodger DJ, Jouary T, Leone G, Moretti S, Nieuweboer-Krobotova L, Olsson MJ, Parsad D, Passeron T, Tanew A, van der Veen W, van Geel N, Whitton M, Wolkerstorfer A, Picardo M; Vitiligo European Task Force (VETF); European Academy of Dermatology and Venereology (EADV); Union Europe enne des Me decins Spe cialistes (UEMS). Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Br J Dermatol. 2013 Jan;168(1):5-19. doi: 10.1111/j.1365-2133.2012.11197.x. Epub 2012 Nov 2.
Lotti T, Buggiani G, Troiano M, Assad GB, Delescluse J, De Giorgi V, Hercogova J. Targeted and combination treatments for vitiligo. Comparative evaluation of different current modalities in 458 subjects. Dermatol Ther. 2008 Jul;21 Suppl 1:S20-6. doi: 10.1111/j.1529-8019.2008.00198.x.
Farajzadeh S, Daraei Z, Esfandiarpour I, Hosseini SH. The efficacy of pimecrolimus 1% cream combined with microdermabrasion in the treatment of nonsegmental childhood vitiligo: a randomized placebo-controlled study. Pediatr Dermatol. 2009 May-Jun;26(3):286-91. doi: 10.1111/j.1525-1470.2009.00926.x.
van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. doi: 10.1159/000051626.
Other Identifiers
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NL45970.018.13
Identifier Type: -
Identifier Source: org_study_id
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