Topical pimecrolimus in the treatment of genital lichen sclerosus

References

• Goto T, Kino T, Hatanaka H et al. Discovery of FK-506, a novel immunosuppressant isolated from Streptomyces tsukubaensis. Transplant. Proc. 19(5 Suppl. 6), 4–8 (1987).
   PubMed Web of Science ®Google Scholar
• Hatanaka H, Iwami M, Kino T et al. FR-900520 and FR-900523, novel immunosuppressants isolated from a Streptomyces. I. Taxonomy of the producing strain. J. Antibiot. 41(11), 1586–1591 (1988).
   PubMed Web of Science ®Google Scholar
• Morisaki M, Arai T. Identity of immunosuppressant FR-900520 with ascomycin. J. Antibiot. 45(1), 126–128 (1992).
   PubMed Web of Science ®Google Scholar
• Meingassner JG, Stütz A. Immunosuppressive macrolides of the type FK 506: a novel class of topical agents for treatment of skin diseases? J. Invest. Dermatol. 98(6), 851–855 (1992).
   PubMed Web of Science ®Google Scholar
• Gupta AK, Chow M. Pimecrolimus: a review. J. Eur. Acad. Dermatol. Venereol. 17(5), 493–503 (2003).
   PubMed Web of Science ®Google Scholar
• Meingassner JG, Kowalsky E, Schwendinger H et al. Pimecrolimus does not affect Langerhans cells in murine epidermis. Br. J. Dermatol. 149(4), 853–857 (2003).
   PubMed Web of Science ®Google Scholar
• Segal AO, Ellis AK, Kim HL. CSACI position statement: safety of topical calcineurin inhibitors in the management of atopic dermatitis in children and adults. Allergy Asthma Clin. Immunol. 9(1), 24 (2013).
   PubMedGoogle Scholar
• Chi CC, Kirtschig G, Baldo M et al. Systematic review and meta-analysis of randomized controlled trials on topical interventions for genital lichen sclerosus. J. Am. Acad. Dermatol. 67(2), 305–312 (2012).
   PubMed Web of Science ®Google Scholar
• Cooper SM, Ali I, Baldo M, Wojnarowska F. The association of lichen sclerosus and erosive lichen planus of the vulva with autoimmune disease: a case-control study. Arch. Dermatol. 144, 1432–1435 (2008).
   PubMedGoogle Scholar
• Wallace HJ. Lichen sclerosus et atrophicus. Trans. St. Johns Hosp. Dermatol. Soc. 57(1), 9–30 (1971).
   PubMedGoogle Scholar
• Jasaitiene D, Valiukeviciene S, Vaitkiene D et al. Lichen sclerosus et atrophicus in pediatric and adult male patients with congenital and acquired phimosis. Medicina (Kaunas) 44, 460–466 (2008).
   PubMed Web of Science ®Google Scholar
• Powell JJ, Wojnarowska F. Lichen sclerosus. Lancet 353, 1777–1783 (1999).
   PubMed Web of Science ®Google Scholar
• Origoni M, Gelardi C, Salvatore S et al. Lichen sclerosus of the vulva. Expert Rev. Obstetr. Gynecol. 8(1), 57–65 (2013).
   Google Scholar
• Pelisse M, Fischesser D, Moyal M et al. Pediatric vulvar lichen sclerosus (22 cases). Ann. Dermatol. Venereol. 111(8), 741–742 (1984).
   PubMed Web of Science ®Google Scholar
• Poindexter G, Morrell DS. Anogenital pruritus: lichen sclerosus in children. Pediatr. Ann. 36, 785–791 (2007).
   PubMed Web of Science ®Google Scholar
• Maronn ML, Esterly NB. Constipation as a feature of anogenital lichen sclerosus in children. Pediatrics 115, 230–232 (2005).
   PubMed Web of Science ®Google Scholar
• Priestley BL, Bleehen SS. Lichen sclerosus and sexual abuse. Arch. Dis. Child. 65(3), 335 (1990).
   PubMed Web of Science ®Google Scholar
• Powell J, Wojnarowska F. Childhood vulval lichen sclerosus and sexual abuse are not mutually exclusive diagnoses. Br. Med. J. 320(7230), 311 (2000).
   PubMedGoogle Scholar
• Jensen LS, Bygum A. Childhood lichen sclerosus is a rare but important diagnosis. Dan. Med. J. 59, A4424 (2012).
   Web of Science ®Google Scholar
• Harrington CI, Dunsmore IR. An investigation into the incidence of auto-immune disorders in patients with lichen sclerosus and atrophicus. Br. J. Dermatol. 104(5), 563–566 (1981).
   PubMed Web of Science ®Google Scholar
• Meyrick Thomas RH, Ridley CM, McGibbon DH et al. Lichen sclerosus et atrophicus and autoimmunity – a study of 350 women. Br. J. Dermatol. 118(1), 41–46 (1988).
   PubMed Web of Science ®Google Scholar
• Kreuter A, Kryvosheyeva Y, Terras S et al. Association of autoimmune diseases with lichen sclerosus in 532 male and female patients. Acta Dermatol. Venereol. 93(2), 238–241 (2013).
   PubMed Web of Science ®Google Scholar
• Baldo M, Bailey A, Bhogal B et al. T cells reactive with the NC16A domain of BP180 are present in vulval lichen sclerosus and lichen planus. J. Eur. Acad. Dermatol. Venereol. 24(2), 186–190 (2010).
   PubMed Web of Science ®Google Scholar
• Azurdia RM, Luzzi GA, Byren I et al. Lichen sclerosus in adult men: a study of HLA associations and susceptibility to autoimmune disease. Br. J. Dermatol. 140(1), 79–83 (1999).
   PubMed Web of Science ®Google Scholar
• Gambichler T, Skrygan M, Tigges C et al. Significant upregulation of antimicrobial peptides and proteins in lichen sclerosus. Br. J. Dermatol. 161(5), 1136–1142 (2009).
   PubMed Web of Science ®Google Scholar
• Oyama N, Chan I, Neill SM et al. Autoantibodies to extracellular matrix protein 1 in lichen sclerosus. Lancet 362(9378), 118–123 (2003).
   PubMed Web of Science ®Google Scholar
• Edmonds E, Barton G, Buisson S et al. Gene expression profiling in male genital lichen sclerosus. Int. J. Exp. Pathol. 92(5), 320–325. (2011).
   PubMed Web of Science ®Google Scholar
• Higgins CA, Cruickshank ME. A population-based case–control study of aetiological factors associated with vulval lichen sclerosus. J. Obstet. Gynaecol. 32(3), 271–275 (2012).
   PubMedGoogle Scholar
• Gutiérrez-Pascual M, Vicente-Martín FJ, López-Estebaranz JL. Lichen sclerosus and squamous cell carcinoma. Actas Dermosifiliogr. 103, 21–28 (2012).
   Google Scholar
• Nasca MR, Innocenzi D, Micali G. Penile cancer among patients with genital lichen sclerosus. J. Am. Acad. Dermatol. 41(6), 911–914 (1999).
   PubMed Web of Science ®Google Scholar
• Meffert JJ, Davis BM, Grimwood RE. Lichen sclerosus. J. Am. Acad. Dermatol. 32(3), 393–416 (1995).
   PubMed Web of Science ®Google Scholar
• van der Avoort IA, Shirango H, Hoevenaars BM et al. Vulvar squamous cell carcinoma is a multifactorial disease following two separate and independent pathways. Int. J. Gynecol. Pathol. 25(1), 22–29 (2006).
   PubMed Web of Science ®Google Scholar
• Fung MA, LeBoit PE. Light microscopic criteria for the diagnosis of early vulvar lichen sclerosus: a comparison with lichen planus. Am. J. Surg. Pathol. 22(4), 473–478 (1998).
   PubMed Web of Science ®Google Scholar
• Hewitt J. Histologic criteria for lichen sclerosus of the vulva. J. Reprod. Med. 31(9), 781–787 (1986).
   PubMed Web of Science ®Google Scholar
• Mihara Y, Mihara M, Hagari Y et al. Lichen sclerosus et atrophicus. A histological, immunohistochemical and electron microscopic study. Arch. Dermatol. Res. 286(8), 434–442 (1994).
   PubMed Web of Science ®Google Scholar
• Lukowsky A, Muche JM, Sterry W et al. Detection of expanded T cell clones in skin biopsy samples of patients with lichen sclerosus et atrophicus by T cell receptor-gamma polymerase chain reaction assays. J. Invest. Dermatol. 115(2), 254–259 (2000).
   PubMed Web of Science ®Google Scholar
• Regauer S, Beham-Schmid C. Detailed analysis of the T-cell lymphocytic infiltrate in penile lichen sclerosus: an immunohistochemical and molecular investigation. Histopathology 48(6), 730–735 (2006).
   PubMed Web of Science ®Google Scholar
• Bulusu M, Baumann K, Stuetz A. Chemistry of the immunomodulatory macrolide ascomycin and related analogues. In: Progress in the Chemistry of Organic Natural Products (Volume 94). Kinghorn AD, Falk H, Kobayashi J ( Eds). Springer-Verlag, Wien, 59–126 (2011).
   Google Scholar
• Billich A, Aschauer H, Aszódi A et al. Percutaneous absorption of drugs used in atopic eczema: pimecrolimus permeates less through skin than corticosteroids and tacrolimus. Int. J. Pharm. 269(1), 29–35 (2004).
   PubMed Web of Science ®Google Scholar
• Becker JW, Rotonda J, McKeever BM et al. FK-506-binding protein: three-dimensional structure of the complex with the antagonist L-685,818. J. Biol. Chem. 268(15), 11335–11339 (1993).
   PubMed Web of Science ®Google Scholar
• Grassberger M, Baumruker T, Enz A et al. A novel anti-inflammatory drug, SDZ ASM 981, for the treatment of skin diseases: in vitro pharmacology. Br. J. Dermatol. 141(2), 264–273 (1999).
   PubMed Web of Science ®Google Scholar
• Kalthoff FS, Winiski A, Fichtinger P et al. Differential inhibition of primary versus preactivated T cells by pimecrolimus but not by tacrolimus in vitro. Int. Arch. Allergy Immunol. 142(3), 255–264. (2007).
   PubMed Web of Science ®Google Scholar
• Hultsch T, Müller KD, Meingassner JG et al. Ascomycin macrolactam derivative SDZ ASM 981 inhibits the release of granule-associated mediators and of newly synthesized cytokines in RBL 2H3 mast cells in an immunophilin-dependent manner. Arch. Dermatol. Res. 290(9), 501–507 (1998).
   PubMed Web of Science ®Google Scholar
• Büchau AS, Schauber J, Hultsch T et al. Pimecrolimus enhances TLR2/6-induced expression of antimicrobial peptides in keratinocytes. J. Invest. Dermatol.128(11), 2646–2654 (2008).
   PubMed Web of Science ®Google Scholar
• Meingassner JG, Grassberger M, Fahrngruber H et al. A novel anti-inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology. Br. J. Dermatol. 137(4), 568–576 (1997).
   PubMed Web of Science ®Google Scholar
• Nell B, Walde I, Billich A et al. The effect of topical pimecrolimus on keratoconjunctivitis sicca and chronic superficial keratitis in dogs: results from an exploratory study. Vet. Ophthalmol. 8(1), 39–46 (2005).
   PubMed Web of Science ®Google Scholar
• Goldstein AT, Marinoff SC, Christopher K. Pimecrolimus for the treatment of vulvar lichen sclerosus in a premenarchal girl. J. Pediatr. Adolesc. Gynecol. 17(1), 35–37 (2004).
   PubMedGoogle Scholar
• Boms S, Gambichler T, Freitag M et al. Pimecrolimus 1% cream for anogenital lichen sclerosus in childhood. BMC Dermatol. 4(1), 14 (2004).
   PubMedGoogle Scholar
• Goldstein AT, Marinoff SC, Christopher K. Pimecrolimus for the treatment of vulvar lichen sclerosus: a report of 4 cases. J. Reprod. Med. 49(10), 778–780 (2004).
   PubMed Web of Science ®Google Scholar
• Nissi R, Eriksen H, Risteli J et al. Pimecrolimus cream 1% in the treatment of lichen sclerosus. Gynecol. Obstet. Invest. 63(3), 151–154 (2007).
   PubMed Web of Science ®Google Scholar
• Oskay T, Sezer HK, Genç C et al. Pimecrolimus 1% cream in the treatment of vulvar lichen sclerosus in postmenopausal women. Int. J. Dermatol. 46(5), 527–532 (2007).
   PubMed Web of Science ®Google Scholar
• Nissi R, Kotila V, Knuuti E, et al. Altered p53 and Bcl-2 expression in keratinocytes of vulvar lichen sclerosus during pimecrolimus treatment. Br. J. Dermatol. 161(4), 958–960 (2009).
   PubMed Web of Science ®Google Scholar
• Kauppila S, Kotila V, Knuuti E et al. The effect of topical pimecrolimus on inflammatory infiltrate in vulvar lichen sclerosus. Am. J. Obstet. Gynecol. 202(2), 181 (2010).
   PubMed Web of Science ®Google Scholar
• Neill SM, Lewis FM, Tatnall FM et al. British Association of Dermatologists. British Association of Dermatologists' guidelines for the management of lichen sclerosus 2010. Br. J. Dermatol. 163(4), 672–682 (2010).
   PubMed Web of Science ®Google Scholar
• Goldstein AT, Creasey A, Pfau R et al. A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus. J. Am. Acad. Dermatol. 64(6), 99–104 (2011).
   Google Scholar
• Ceilley R, Eisenthal A. The unintended effects of a boxed warning. J. Clin. Aesthet. Dermatol. 2(9), 33–39 (2009).
   PubMedGoogle Scholar
• Niwa Y, Terashima T, Sumi H. Topical application of the immunosuppressant tacrolimus accelerates carcinogenesis in mouse skin. Br. J. Dermatol. 149(5), 960–967 (2003).
   PubMed Web of Science ®Google Scholar
• Tran C, Lübbe J, Sorg O et al. Topical calcineurin inhibitors decrease the production of UVB-induced thymine dimers from hairless mouse epidermis. Dermatology 211(4), 341–347 (2005).
   PubMed Web of Science ®Google Scholar
• Naylor M, Elmets C, Jaracz E et al. Non-melanoma skin cancer in patients with atopic dermatitis treated with topical tacrolimus. J. Dermatol. Treat. 16(3), 149–153 (2005).
   PubMed Web of Science ®Google Scholar
• Paul C, Cork M, Rossi AB et al. Safety and tolerability of 1% pimecrolimus cream among infants: experience with 1133 patients treated for up to 2 years. Pediatrics 117(1), 118–128 (2006).
   Web of Science ®Google Scholar
• Meurer M, Fartasch M, Albrecht G et al. Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology 208(4), 365–372 (2004).
   PubMed Web of Science ®Google Scholar
• Papp KA, Werfel T, Fölster-Holst R et al. Long-term control of atopic dermatitis with pimecrolimus cream 1% in infants and young children: a two-year study. J. Am. Acad. Dermatol. 52(2), 240–246 (2005).
   PubMed Web of Science ®Google Scholar
• Bunker CB. Comments on the British Association of Dermatologists guidelines for the management of lichen sclerosus. Br. J. Dermatol. 164(4), 894–895 (2011).
   PubMed Web of Science ®Google Scholar
• Eichenfield LF, Lucky AW, Boguniewicz M et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J. Am. Acad. Dermatol. 46(4), 495–504 (2002).
   PubMed Web of Science ®Google Scholar
• Johnson E, Groben P, Eanes A et al. Vulvar skin atrophy induced by topical glucocorticoids. J. Midwifery Womens Health 57(3), 296–299 (2012).
   PubMed Web of Science ®Google Scholar
• Pérez-López FR, Ceausu I, Depypere H et al. EMAS clinical guide: Vulvar lichen sclerosus in peri and postmenopausal women. Maturitas S0378–S5122(12), 406–409 (2013).
   Google Scholar
• Maassen MS, van Doorn HC. Topical treatment of vulvar lichen sclerosus with calcineurin inhibitors. Ned. Tijdschr. Geneeskd. 156(36), A3908 (2012).
   Google Scholar
• Fistarol SK, Itin PH. Diagnosis and treatment of lichen sclerosus: an update. Am. J. Clin Dermatol. 14(1), 27–47 (2013).
   PubMed Web of Science ®Google Scholar
• Parker LU, Bergfeld WF. Virilization secondary to topical testosterone. Cleve. Clin. J. Med. 58(1), 43–46 (1991).
   PubMed Web of Science ®Google Scholar
• Ioannides D, Lazaridou E, Apalla Z et al. Acitretin for severe lichen sclerosus of male genitalia: a randomized, placebo controlled study. J. Urol. 183(4), 1395–1359 (2010).
   PubMed Web of Science ®Google Scholar
• Virgili A, Corazza M, Bianchi A, Mollica G, Califano A. Open study of topical 0.025% tretinoin in the treatment of vulvar lichen sclerosus. One year of therapy. J. Reprod. Med. 40(9), 614–618 (1995).
   PubMed Web of Science ®Google Scholar
• Reichrath J, Reinhold U, Tilgen W. Treatment of genito-anal lesions in inflammatory skin diseases with PUVA cream photochemotherapy: an open pilot study in 12 patients. Dermatology 205(3), 245–248 (2002).
   PubMed Web of Science ®Google Scholar
• Beattie PE, Dawe RS, Ferguson J et al. UVA1 phototherapy for genital lichen sclerosus. Clin. Exp. Dermatol. 31(3), 343–347 (2006).
   PubMed Web of Science ®Google Scholar
• Hillemanns P, Untch M, Pröve F et al. Photodynamic therapy of vulvar lichen sclerosus with 5-aminolevulinic acid. Obstet. Gynecol. 93(1), 71–74 (1999).
   PubMed Web of Science ®Google Scholar
• Sotiriou E, Panagiotidou D, Ioannidis D. An open trial of 5-aminolevulinic acid therapy for vulvar lichen sclerosus. Eur. J. Obstet. Gynecol. Reprod. Biol. 141(2), 187–188 (2008).
   PubMed Web of Science ®Google Scholar
• Zawislak AA, McCluggage WG, Donnelly RF et al. Response of vulval lichen sclerosus and squamous hyperplasia to photodynamic treatment using sustained topical delivery of aminolevulinic acid from a novel bioadhesive patch system. Photodermatol. Photoimmunol. Photomed. 25(2), 111–113 (2009).
   PubMed Web of Science ®Google Scholar
• Olejek A, Steplewska K, Gabriel A et al. Efficacy of photodynamic therapy in vulvar lichen sclerosus treatment based on immunohistochemical analysis of CD34, CD44, myelin basic protein, and Ki67 antibodies. Int. J. Gynecol. Cancer 20(5), 879–887 (2010).
   PubMed Web of Science ®Google Scholar