백반증이 현행 ‘사33 피부과적 자외선 치료’ 및 ‘백반 또는 백납에 대한 치료의 급여 여부’ 고시에서 얼굴과 목, 손 등 노출부위에 한해 급여 인정되고 있는 점, 가이드라인에서 얼굴과 목 부위에 스테로이드 외용제보다 우선 권고되고 있는 점을 고려하여 얼굴과 목 부위에 요양급여를 인정하고,
식약처 허가사항에서 2세 미만의 소아에게는 약제 사용을 금하고 있는 점을 고려하여 투여 대상을 성인 및 2세 이상의 소아로 한정 함.
■ 관련문헌 등
· Harrison's Principles of Internal Medicine, 20e > Chapter 54: Skin Manifestations of Internal Disease > HYPOPIGMENTATION
· Fitzpatrick's Dermatology in General Medicine, 8e 2012 > Chapter 74. Vitiligo > Treatment
· Clinical Dermatology Sixth Edition 2016 > Chapter 19. Light-related diseases and disorders of pigmentation > DISORDERS OF HYPOPIGMENTATION > Vitiligo
· A. Taieb, et al. Guidelines for the Management of Vitiligo. The European Dermatology Forum Consensus, 2012 British Association of Dermatologists 2013 168, pp5？19
· Naoki OISO, et al. Guidelines for the diagnosis and treatment of vitiligo in Japan, Journal of Dermatology 2013; 40: 344？354.
· A. Wollenberg, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I, JEADV 2018, 32, 657？682.
· Ichiro Katayama, et al. Japanese guidelines for atopic dermatitis 2017*, Allergology International 66 (2017) 230e247
· Bae JM, et al. The efficacy of 308-nm excimer laser/light (EL) and topical agent combination therapy versus EL monotherapy for vitiligo: A systematic review and meta-analysis of randomized controlled trials (RCTs). J Am Acad Dermatol. 2016 May;74(5):907-15.
· Bapur Erduran F, et al. Comparison of the efficacy of 308-nm excimer lamp monotherapy with topical tacrolimus or clobetasol 17-propionate combination therapies in localized vitiligo. Photodermatol Photoimmunol Photomed. 2016 Sep;32(5-6):247-253.
· Sisti A, et al. Effectiveness and safety of topical tacrolimus monotherapy for repigmentation in vitiligo: a comprehensive literature review. An Bras Dermatol. 2016 Apr;91(2):187-95.
· Park OJ, et al. A combination of excimer laser treatment and topical tacrolimus is more effective in treating vitiligo than either therapy alone for the initial 6 months, but not thereafter. Clin Exp Dermatol. 2016 Apr;41(3):236-41.
· Cavalie M, et al. Maintenance therapy of adult vitiligo with 0.1% tacrolimus ointment: a randomized, double blind, placebo-controlled study. J Invest Dermatol. 2015 Apr;135(4):970-4.
· Ho N, et al. A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0·1% vs. clobetasol propionate 0·05% in childhood vitiligo. Br J Dermatol. 2011 Sep;165(3):626-32.
· Majid I, et al. Does topical tacrolimus ointment enhance the efficacy of narrowband ultraviolet B therapy in vitiligo? A left-right comparison study. Photodermatol Photoimmunol Photomed. 2010 Oct;26(5):230-4.
· de Menezes AF, et al. Pharmacologic Treatment of Vitiligo in Children and Adolescents: A Systematic Review. Pediatr Dermatol. 2017 Jan;34(1):13-24.
· Dang YP, et al. Effect of topical calcineurin inhibitors as monotherapy or combined with phototherapy for vitiligo treatment: a meta-analysis. Dermatol Ther. 2016 Mar-Apr;29(2):126-33.
· Roy P, et al. Effectiveness of Topical Corticosteroid, Topical Calcineurin Inhibitors and Combination of Them in the Treatment of Vitiligo. Mymensingh Med J. 2016 Oct;25(4):620-627.
· Dayal S, et al. Treatment of Childhood Vitiligo Using Tacrolimus Ointment with Narrowband Ultraviolet B Phototherapy. Pediatr Dermatol. 2016 Nov;33(6):646-651.
· Njoo MD, et al. Nonsurgical repigmentation therapies in vitiligo. Meta-analysis of the literature. Arch Dermatol. 1998 Dec;134(12):1532-40.
· Lepe V, et al. A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol. 2003 May;139(5):581-5.
· Farajzadeh S, et al. 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.
· Shim WH, et al. A pilot study of 1% pimecrolimus cream for the treatment of childhood segmental vitiligo. Ann Dermatol. 2013 May;25(2):168-72.
· Kose O, et al. Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo. J Dermatolog Treat. 2010 May;21(3):133-9.
· Dawid M, et al. Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study. J Dtsch Dermatol Ges. 2006 Nov;4(11):942-6.
· Kumaran MS, et al. Effect of topical calcipotriol, betamethasone dipropionate and their combination in the treatment of localized vitiligo. J Eur Acad Dermatol Venereol. 2006 Mar;20(3):269-73.
· Esfandiarpour I, et al. The efficacy of pimecrolimus 1% cream plus narrow-band ultraviolet B in the treatment of vitiligo: a double-blind, placebo-controlled clinical trial. J Dermatolog Treat. 2009;20(1):14-8.
· Kathuria S, et al. Segmental vitiligo: a randomized controlled trial to evaluate efficacy and safety of 0.1% tacrolimus ointment vs 0.05% fluticasone propionate cream. Indian J Dermatol Venereol Leprol. 2012 Jan-Feb;78(1):68-73.
· Westerhof W, et al. Left-right comparison study of the combination of fluticasone propionate and UV-A vs. either fluticasone propionate or UV-A alone for the long-term treatment of vitiligo. Arch Dermatol. 1999 Sep;135(9):1061-6.
· Coskun B, et al. Topical 0.05% clobetasol propionate versus 1% pimecrolimus ointment in vitiligo. Eur J Dermatol. 2005 Mar-Apr;15(2):88-91.
· Jordi Castellsague, et al. A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation ？ JOELLE study). Clinical Epidemiology 2018:10 299？310.
· David J, et al. Association Between Malignancy and Topical Use of Pimecrolimus. JAMA Dermatology Published online February 18, 2015.
· S. C. S. Cai, et al. Topical calcineurin inhibitors in eczema and cancer association: A cohort study. JOURNAL OF DERMATOLOGICAL TREATMENT, 2016.