Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

Vitiligo Clinical Trial

Official title:

Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02290717
• Other study ID #: NL45970.018.13
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2014
• Last updated: April 15, 2016
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Netherlands Institute for Pigment Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• Fractional CO2 laser

Other:
• 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.

Drug:
• Fluticasone Propionate Cream 0.05%
4 times a week (standard IPD protocol)

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Netherlands Institute for Pigment Disorders

Country where clinical trial is conducted

Netherlands, 

References & Publications (13)

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):473-91. doi: 10.1016/j.jaad.2010.11.061. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. Review. — View Citation

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. — View Citation

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. — View Citation

Taieb A, Alomar A, Böhm 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. — View Citation

Taïeb A, Picardo M. Clinical practice. Vitiligo. N Engl J Med. 2009 Jan 8;360(2):160-9. doi: 10.1056/NEJMcp0804388. Review. — View Citation

van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		6 months after treatment	Yes
Other	Color difference between erythema and (re)pigmentation	with a Derma-spectrometer the difference between erythema and (re)pigmentation will be assessed.	6 months after treatment	No
Primary	Repigmentation % with sheets	% of repigmentation	6 mo after treatment	No
Secondary	Global assessment physician		6 months after treatment	No
Secondary	Global assessment patient		6 months after treatment	No
Secondary	Visual assessment of hyperpigmentation/hypopigmentation/scar formation		6 months after treatment	No
Secondary	Global assessment of repigmentation physician		6months after treatment	No