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| Name | Class |
|---|---|
| Avita Medical | INDUSTRY |
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The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. With this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. Currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. There is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using ReCell (ReCell grafting). The investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. Furthermore, infiltration anaesthesia is not necessary with these less invasive treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full surface CO2 laser 200mJ + ReCell | Active Comparator | This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 209 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region. |
|
| Full surface CO2 laser 150mJ + ReCell | Experimental | This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region. |
|
| Fractional CO2 laser 7.5mJ 20% + ReCell | Experimental | This test region will receive pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region. |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCell | Device | A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site. |
| Measure | Description | Time Frame |
|---|---|---|
| Repigmentation | Assessment will be done by sheets and a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before and six months after treatment, after which the sheets are scanned using a predefined resolution. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch are computed. | 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| PhGA | Blinded physician's assessment of repigmentation. Repigmentation will be classified as follows: 0-25%, 26-50%, 51-75%, 76-95%, 96-100% six months. | 6 months after intervention |
| Side effects |
| Measure | Description | Time Frame |
|---|---|---|
| Skin type | Fitzpatrick skin type | week 0 |
| VIDA score | Classification of disease activity according to VIDA scale | week 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Wolkerstorfer, MD, PhD | Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam | Principal Investigator |
| Menno A. De Rie, MD, PhD | Department of Dermatology, Academic Medical Center, University of Amsterdam | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Institute for Pigment disorders | Amsterdam | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11306848 | Background | van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. doi: 10.1159/000051626. | |
| 17927795 | Background | Mulekar SV, Ghwish B, Al Issa A, Al Eisa A. Treatment of vitiligo lesions by ReCell vs. conventional melanocyte-keratinocyte transplantation: a pilot study. Br J Dermatol. 2008 Jan;158(1):45-9. doi: 10.1111/j.1365-2133.2007.08216.x. Epub 2007 Oct 10. |
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| ID | Term |
|---|---|
| D016116 | Piebaldism |
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D000417 | Albinism |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
|
| Full surface CO2 laser 200 mJ | Device | Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 144 µm) and density 3 |
|
| Full surface CO2 laser 150 mJ | Device | Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3 |
|
| Fractional CO2 laser 7.5 mJ, 20% | Device | Pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density. |
|
Visual assessment of side effects per treatment region (erythema, hyperpigmentation, hypopigmentation and scar on a scale from 0-3) will be done by a blinded investigator six months.
| 6 months after intervention |
| Reepithelialization | One week after grafting reepithelialization will be assessed by a blinded physician and estimated on a 0 to 100% scale. | 1 week after intervention |
| Colour difference | Colour difference i.e. the difference between normal pigmentation, erythema, and hyperpigmentation will be assessed with a DermaSpectrometer (Cortex Technology ApS, Hadsund, Denmark) | 6 months after intervention |
| PGA | General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent). | 6 months after intervention |
| Pain | One week after grafting, pain will be assessed after grafting on a 100 mm visual analogue scale (VAS) per treatment region | 1 week after intervention |
| Cell count | The superfluous of the suspension will be used for flow cytometric analyses of the cellular composition of the graft. | up to six hours |
| Duration of disease | Duration of disease | week 0 |
| 15216537 | Background | Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048. |
| 19850197 | Background | Brightman LA, Brauer JA, Anolik R, Weiss E, Karen J, Chapas A, Hale E, Bernstein L, Geronemus RG. Ablative and fractional ablative lasers. Dermatol Clin. 2009 Oct;27(4):479-89, vi-vii. doi: 10.1016/j.det.2009.08.009. |
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| 12410698 | Background | Olsson MJ, Juhlin L. Long-term follow-up of leucoderma patients treated with transplants of autologous cultured melanocytes, ultrathin epidermal sheets and basal cell layer suspension. Br J Dermatol. 2002 Nov;147(5):893-904. doi: 10.1046/j.1365-2133.2002.04837.x. |
| 8859294 | 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. |
| 11705094 | Background | Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. doi: 10.2165/00128071-200102030-00006. |
| 19129529 | 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. |
| 8912558 | Background | Hann SK, Lee HJ. Segmental vitiligo: clinical findings in 208 patients. J Am Acad Dermatol. 1996 Nov;35(5 Pt 1):671-4. doi: 10.1016/s0190-9622(96)90718-5. |
| 15194144 | Background | Murakami T, Fukai K, Oiso N, Hosomi N, Kato A, Garganta C, Barnicoat A, Poppelaars F, Aquaron R, Paller AS, Ishii M. New KIT mutations in patients with piebaldism. J Dermatol Sci. 2004 Jun;35(1):29-33. doi: 10.1016/j.jdermsci.2004.03.003. |
| 20804490 | Background | van Geel N, Wallaeys E, Goh BK, De Mil M, Lambert J. Long-term results of noncultured epidermal cellular grafting in vitiligo, halo naevi, piebaldism and naevus depigmentosus. Br J Dermatol. 2010 Dec;163(6):1186-93. doi: 10.1111/j.1365-2133.2010.10014.x. |
| 19577331 | 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. |
| 15948977 | 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. |
| 21839315 | 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. |
| 19673878 | Background | Fongers A, Wolkerstorfer A, Nieuweboer-Krobotova L, Krawczyk P, Toth GG, van der Veen JP. Long-term results of 2-mm punch grafting in patients with vitiligo vulgaris and segmental vitiligo: effect of disease activity. Br J Dermatol. 2009 Nov;161(5):1105-11. doi: 10.1111/j.1365-2133.2009.09367.x. Epub 2009 Jun 22. |
| 2670786 | Background | Falabella R. Grafting and transplantation of melanocytes for repigmenting vitiligo and other types of leukoderma. Int J Dermatol. 1989 Jul-Aug;28(6):363-9. doi: 10.1111/j.1365-4362.1989.tb02479.x. No abstract available. |
| 19036036 | Background | Gawkrodger DJ, Ormerod AD, Shaw L, Mauri-Sole I, Whitton ME, Watts MJ, Anstey AV, Ingham J, Young K; Therapy Guidelines and Audit Subcommittee, British Association of Dermatologists; Clinical Standards Department, Royal College of Physicians of London; Cochrane Skin Group; Vitiligo Society. Guideline for the diagnosis and management of vitiligo. Br J Dermatol. 2008 Nov;159(5):1051-76. doi: 10.1111/j.1365-2133.2008.08881.x. |
| 20709768 | Background | Gawkrodger DJ, Ormerod AD, Shaw L, Mauri-Sole I, Whitton ME, Watts MJ, Anstey AV, Ingham J, Young K. Vitiligo: concise evidence based guidelines on diagnosis and management. Postgrad Med J. 2010 Aug;86(1018):466-71. doi: 10.1136/pgmj.2009.093278. |
| 10325459 | Background | Malakar S, Dhar S. Treatment of stable and recalcitrant vitiligo by autologous miniature punch grafting: a prospective study of 1,000 patients. Dermatology. 1999;198(2):133-9. doi: 10.1159/000018089. |
| 7490371 | Background | Boersma BR, Westerhof W, Bos JD. Repigmentation in vitiligo vulgaris by autologous minigrafting: results in nineteen patients. J Am Acad Dermatol. 1995 Dec;33(6):990-5. doi: 10.1016/0190-9622(95)90292-9. |
| 15492183 | Background | Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5. doi: 10.1001/archderm.140.10.1211. |
| 17904748 | Background | Gravante G, Di Fede MC, Araco A, Grimaldi M, De Angelis B, Arpino A, Cervelli V, Montone A. A randomized trial comparing ReCell system of epidermal cells delivery versus classic skin grafts for the treatment of deep partial thickness burns. Burns. 2007 Dec;33(8):966-72. doi: 10.1016/j.burns.2007.04.011. Epub 2007 Sep 29. |
| 11227683 | Background | Navarro FA, Stoner ML, Lee HB, Park CS, Wood FM, Orgill DP. Melanocyte repopulation in full-thickness wounds using a cell spray apparatus. J Burn Care Rehabil. 2001 Jan-Feb;22(1):41-6. doi: 10.1097/00004630-200101000-00009. |
| 22079538 | Background | Wood FM, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension harvested from the dermal epidermal junction using a ReCell(R) kit. Burns. 2012 Feb;38(1):44-51. doi: 10.1016/j.burns.2011.03.001. Epub 2011 Nov 12. |
| 20021980 | Background | Cervelli V, De Angelis B, Balzani A, Colicchia G, Spallone D, Grimaldi M. Treatment of stable vitiligo by ReCell system. Acta Dermatovenerol Croat. 2009;17(4):273-8. |
| 20707289 | Background | Cervelli V, Spallone D, Lucarini L, Palla L, Brinci L, De Angelis B. Treatment of stable vitiligo hands by ReCell system: a preliminary report. Eur Rev Med Pharmacol Sci. 2010 Aug;14(8):691-4. |
| 10150575 | Background | Chernoff G, Slatkine M, Zair E, Mead D. SilkTouch: a new technology for skin resurfacing in aesthetic surgery. J Clin Laser Med Surg. 1995 Apr;13(2):97-100. doi: 10.1089/clm.1995.13.97. |
| 17115384 | Background | Hantash BM, Bedi VP, Chan KF, Zachary CB. Ex vivo histological characterization of a novel ablative fractional resurfacing device. Lasers Surg Med. 2007 Feb;39(2):87-95. doi: 10.1002/lsm.20405. |
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| 8948539 | Background | Ragland HP, McBurney E. Complications of resurfacing. Semin Cutan Med Surg. 1996 Sep;15(3):200-7. doi: 10.1016/s1085-5629(96)80051-4. |
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| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D012873 | Skin Diseases, Genetic |
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |