Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

NCT02290717 | Withdrawn

• 1 other identifier: NL45970.018.13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life. Many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment. Therefore new therapeutic options in these patients are necessary. Currently, dermabrasion by conventional or fractional laser therapy in combination with NB-UVB therapy and steroids appears to be effective in therapy resistant areas. However, little literature on this combination is available. 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.

Conditions

Vitiligo

Keywords

ultraviolet therapy; non segmental; vitiligo; topical corticosteroid; laser; fractional; CO2; carbon dioxide; UVB

Outcome Measures

Primary Outcomes (1)

• Repigmentation % with sheets

  % of repigmentation

  6 mo after treatment

Secondary Outcomes (4)

• Global assessment physician

  6 months after treatment

• Global assessment patient

  6 months after treatment

• Visual assessment of hyperpigmentation/hypopigmentation/scar formation

  6 months after treatment

• Global assessment of repigmentation physician

  6months after treatment

Other Outcomes (2)

• Adverse events

  6 months after treatment

• Color difference between erythema and (re)pigmentation

  6 months after treatment

Study Arms (3)

Laser+fluticason+UVB

EXPERIMENTAL

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.

Device: Fractional CO2 laser; Other: NB-UVB therapy; Drug: Fluticasone Propionate Cream 0.05%

Laser+UVB

EXPERIMENTAL

In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).

Device: Fractional CO2 laser; Other: NB-UVB therapy

UVB

ACTIVE COMPARATOR

As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2.

Other: NB-UVB therapy

Interventions

Fractional CO2 laser DEVICE

Laser+UVB; Laser+fluticason+UVB

NB-UVB therapy OTHER

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.

Laser+UVB; Laser+fluticason+UVB; UVB

Fluticasone Propionate Cream 0.05% DRUG

4 times a week (standard IPD protocol)

Laser+fluticason+UVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non segmental (generalised) vitiligo visiting the Netherlands Institute for Pigment Disorders
• 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

You may not qualify if:

• Skin type I
• 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.

Sponsors & Collaborators

• Netherlands Institute for Pigment Disorders: lead

Study Sites (1)

Academic Medical Centre

Amsterdam, Netherlands

Location

Related Publications (13)

• 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.

  PMID: 21834930 BACKGROUND

• 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.

  PMID: 22050270 BACKGROUND

• 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.

  PMID: 21824124 BACKGROUND

• 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.

  PMID: 19577331 BACKGROUND

• 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.

  PMID: 15948977 BACKGROUND

• 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.

  PMID: 21839315 BACKGROUND

• 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.

  PMID: 8859294 BACKGROUND

• Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. doi: 10.2165/00128071-200102030-00006.

  PMID: 11705094 BACKGROUND

• 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.

  PMID: 19129529 BACKGROUND

• 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.

  PMID: 22860621 BACKGROUND

• 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.

  PMID: 18727812 BACKGROUND

• 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.

  PMID: 19706089 BACKGROUND

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  PMID: 11306848 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc MD

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

NL (1)