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Double-blind Placebo-Controlled Study of Autologous Transplanted Epidermal Cell Suspensions for Repigmenting Vitiligo
Nanny van Geel, MD;
Katia Ongenae, MD;
Martine De Mil;
Yves Vander Haeghen, PhD;
Chris Vervaet, PhD;
Jean Marie Naeyaert, MD, PhD
Arch Dermatol. 2004;140:1203-1208.
Objectives To investigate the efficacy of epidermal noncultured cellular grafting in patients with vitiligo and the role of postinflammatory, spontaneous, or UV-induced pigmentation in obtaining repigmentation.
Design A prospective, randomized, double-blind, placebo-controlled study.
Setting Ambulatory patients in an institutional practice. Patients were followed up for 3 to 12 months.
Patients A total of 33 paired, symmetrically distributed leukodermic lesions, all resistant to therapy, were observed in 28 patients. Nineteen patients appeared to have a stable vitiligo (group 1), whereas there was doubt about the stability of the disease in 9 patients (group 2).
Intervention After laser ablation, a hyaluronic acidenriched cellular graft was applied to 1 lesion while the paired lesion received placebo. Three weeks later all lesions were exposed to UV irradiation twice per week for approximately 2 months.
Main Outcome Measures Primarily, the percentage of repigmentation was assessed after 3, 6, and 12 months using a digital image analysis system. The repigmentation pattern was also evaluated after 1 and 3 months.
Results A strongly significant difference between cellular grafts and placebo was observed after 3, 6, and 12 months (P<.001, P = .002, and P = .002, respectively). In group 1, repigmentation of at least 70% of the treated area was achieved in 55%, 57%, and 77% of the actively treated lesions 3, 6, and 12 months after treatment, whereas in group 2 repigmentation of at least 70% of the treated area was not observed at any time point. The repigmentation pattern was diffuse in 94% of the responding patients.
Conclusions After a strict preoperative selection for disease stability, transplantation resulted in repigmentation of at least 70% of the treated area in most actively treated vitiligo lesions. Repigmentation was primarily caused by the transplanted melanocytes.
From the Department of Dermatology, Ghent University Hospital (Drs van Geel, Ongenae, Vander Haeghen, and Naeyaert and Ms De Mil), and the Laboratory of Pharmaceutical Technology (Dr Vervaet), Ghent University, Ghent, Belgium. The authors have no relevant financial interest in this article.
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