Lichen sclerosus (LS) is an inflammatory and chronic disease that causes itching, pain, dysuria, urinary retention, dyspareunia and sexual dysfunction, in both men and women. The first line pharmacological treatment is based on the use of topical steroids, which have proved their efficacy in 60-70% of cases but with a high rate of relapses in time (50-80% of the patients of both sexes). The purpose of our non-randomised prospective pilot study was to evaluate the efficacy and tolerability of a new loco regional therapy with polydeoxyribonucleotides (PDRN) in the treatment of male genital LS. PDRN is an healing and anti-dystrophic drug with anti-inflammatory effects, through the reduction of cytokine. Twenty one male patients suffering from genital LS were recruited. All the patients were submitted to treatment using loco-regional intradermal injections with PDRN. Dermatology Life Quality Index (DLQI), International Index of Erectile Function (IIEF-5) and PGI-I questionnaires were administered at baseline and at the end of treatment in order to evaluate the results of this treatment. The statistical evaluation of the data obtained with the DLQI questionnaire showed a marked improvement of the overall conditions in terms of quality of life, with an average change of scores from 15 to 4 (p < 0.0001). PGI-I questionnaire showed that 80% of the patients treated considered their post-treatment conditions as ‘improved'. There was no significant change in terms of sexual function according to the IIEF questionnaire (p = 0.189). The results obtained show the excellent tolerability and the therapeutic efficacy of PDRN, with clear improvement of the local symptoms and of the quality of life.

Keywords:
Polydeoxyribonucleotides, Dermatology life quality index, Lichen sclerosus treatment
1.
Lipscombe TK, Wayte J, Wojnarowska F, et al: A study of clinical and aetiological factors and possible associations of lichen sclerosus in males. Australas J Dermatol 1997;38:132-136.
2.
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 1999;140:79-83.
3.
Meyrick Thomas RH, Ridley CM, McGibbon DH, et al: Lichen sclerosus et atrophicus and autoimmunity: a study of 350 women. Br J Dermatol 1988;118:41-46.
4.
Murphy R: Lichen sclerosus. Dermatol Clin 2010;28:707-715.
5.
Cooper SM, Ali I, Baldo M, et al: The association of lichen sclerosus and erosive lichen planus of the vulva with autoimmune disease: a case-control study. Arch Dermatol 2008;144:1432-1435.
6.
Birenbaum DL, Young RC: High prevalence of thyroid disease in patients with lichen sclerosus. J Reprod Med 2007;52:28-30.
7.
Leese GP, Flynn RV, Jung RT, et al: Increasing prevalence and incidence of thyroid disease in Tayside, Scotland: the Thyroid Epidemiology Audit and Research Study (TEARS). Clin Endocrinol (Oxf) 2008;68:311-316.
8.
Powell J, Wojnarowska F, Winsey S, et al: Lichen sclerosus premenarche: autoimmunity and immunogenetics. Br J Dermatol 2000;142:481-484.
9.
Oyama N, Chan I, Neill SM, et al: Autoantibodies to extracellular matrix protein 1 in lichen sclerosus. Lancet 2003;362:118-123.
10.
Edmonds EV, Oyama N, Chan I, et al: Extracellular matrix protein 1 autoantibodies in male genital lichen sclerosus. Br J Dermatol 2011;165:218-219.
11.
Bunker CB: Male genital lichen sclerosus and tacrolimus. Br J Dermatol 2007;157:1079-1080.
12.
Bunker CB, Edmonds E, Hawkins D, et al: Re: Lichen sclerosus: review of the literature and current recommendations for management. J Urol 2007;178:2268-2276; J Urol 2009;181:1802-1803.
13.
Edmonds EV, Hunt S, Hawkins D, et al: Clinical parameters in male genital lichen sclerosus: a case series of 329 patients. J Eur Acad Dermatol Venereol 2012;26:730-737.
14.
Edmonds EV, Bunker CB: Nuclear magnetic resonance spectroscopy of urine in male genital lichen sclerosus. Br J Dermatol 2010;163:1355-1356.
15.
Eisendle K, Grabner T, Kutzner H, et al: Possible role of Borrelia burgdorferi sensu lato infection in lichen sclerosus. Arch Dermatol 2008;144:591-598.
16.
Friedrich EG Jr, Kalra PS: Serum levels of sex hormones in vulvar lichen sclerosus, and the effect of topical testosterone. N Engl J Med 1984;310:488-491.
17.
Clifton MM, Garner IB, Kohler S, et al: Immunohistochemical evaluation of androgen receptors in genital and extragenital lichen sclerosus: evidence for loss of androgen receptors in lesional epidermis. J Am Acad Dermatol 1999;41:43-46.
18.
Edmonds EV, Hunt S, Hawkins D, et al: Clinical parameters in male genital lichen sclerosus: a case series of 329 patients. J Eur Acad Dermatol Venereol 2012;26:730-737.
19.
Cooper SM, Gao XH, Powell JJ, et al: Does treatment of vulvar lichen sclerosus influence its prognosis? Arch Dermatol 2004;140:702-706.
20.
Renaud-Vilmer C, Cavelier-Balloy B, Porcher R, et al: Vulvar lichen sclerosus: effect of long-term topical application of a potent steroid on the course of the disease. Arch Dermatol 2004;140:709-712.
21.
Fistarol SK, Itin PH: Anti-inflammatory treatment. Curr Probl Dermatol 2011;40:58-70.
22.
Yesudian PD: The role of calcineurin inhibitors in the management of lichen sclerosus. Am J Clin Dermatol 2009;10:313-318.
23.
Chi CC, Kirtschig G, Baldo M, Brackenbury F, Lewis F, Wojnarowska F: Topical interventions for genital lichen sclerosus. Cochrane Database Syst Rev 2011;12:CD008240.
24.
Fistarol SK, Itin PH: Diagnosis and treatment of lichen sclerosus - an update. Am J Clin Dermatol 2013;14:27-47.
25.
Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY: The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol 2008;159:997-1035.
26.
Viktrup L, Hayes RP, Wang P, et al: Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol 2012;12:30.
27.
Yalcin I, Bump RC: Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98-101.
28.
Funaro D: Lichen sclerosus: a review and practical approach. Dermatol Ther 2004;17:28-37.
29.
Laino L, Suetti S, Sperduti I: Polydeoxyribonucleotide dermal infiltration in male genital lichen sclerosus: adjuvant effects during topical therapy. Dermatol Res Pract 2013;2013:654079.
30.
Guizzardi S, Galli C, Govoni P, Boratto R, Cattarini G, Martini D, Belletti S, Scandroglio R: Polydeoxyribonucleotide (PDRN) promotes human osteoblast proliferation: a new proposal for bone tissue repair. Life Sci 2003;73:1973-1983.
31.
Rubegni P, De Aloe G, Mazzatenta C, Cattarini L, Fimiani M: Clinical evaluation of the trophic effect of polydeoxyribonucleotide (PDRN) in patients undergoing skin explants. A pilot study. Curr Med Res Opin 2001;17:128-131.
32.
Sini P, Denti A, Cattarini G, Daglio M, Tira Me, Balduini C: Effect of polydeoxyribonucleotides on human fibroblasts in primary culture. Cell Biochem Funct 1999;17:107-114.
33.
Bitto A, Minatoli L, Polito F, Altavilla D, Cattarini G, Squadrito F: Polydeoxyribonucleotide improves angiogenesis and wound healing in experimental burn wounds. Purinergic Signal 2006;2:290-291.
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2016
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