Abstract
Background. Lichen sclerosus (LS) is an autoimmune inflammatory skin disease that leads to tissue sclerosis. Actually, the first-line treatment consists of local steroid as clobetasol propionate (CP). Polydeoxyribonucleotide (PDRN) has demonstrated anti-inflammatory effects through the reduction of cytokine production and growth stimulation of fibroblast. Objective. To evaluate the efficacy of intradermal administration of PDRN in male patients suffering from genital lichen sclerosus in addition to topical 0.05% CP, as compared to administering 0.05% CP without PDRN injection. Patients/Methods. A group of male patients (n = 28; aged 25 to 65) suffering from LS were observed during topical therapy or subdermal in addition to topical therapy. Disease activity at baseline was evaluated on Investigator's Global Assessment (IGA) and the Dermatology Life Quality Index (DLQI). We used polydeoxyribonucleotide in a commercial preparation for human use and a topical CP emulsion. Results. After therapy, in all group A patients there has been a regression of most of clinical pathological signs, while there has been a moderate improvement in all group B patients. Conclusions. On site intradermal administration of PDRN, associated with CP 0.05% cream, seemed to be associated with a clinical improvement of lichen sclerosus better than CP used in single therapy.
Highlights
Several researchers have shed new light on the importance of the action of extracellular nucleotides and nucleosides in increasing cell proliferation and reducing inflammation
All patients gave their informed consent to the treatment after an exhaustive explanation of effects, side or unwanted effects, especially related to ultrapotent corticosteroid topical application and subdermal administration of PDRN; all patients conduct rules before, during, and after treatment; in particular, the patients are informed that the clobetasol propionate— in accordance with the latest guidelines published by British Association of Dermatologists [10]—is the only first-line therapy in course of lichen sclerosus and that polydeoxyribonucleotide solution—proposed by us only as adjuvant therapy—is currently available in Italy as drug suitable for subcutaneous infiltration; PDRN are recognized by Pharmacopoeia as “drugs without side or unwanted known effects” and no side or un wanted effects are described in the international scientific literature”
We could observe a reduction of Investigator’s Global Assessment (IGA) (P = 0.003, Figure 4) and Dermatology Life Quality Index (DLQI) score (P < 0.0001, Figure 5) in group A greater than in group B
Summary
Several researchers have shed new light on the importance of the action of extracellular nucleotides and nucleosides in increasing cell proliferation and reducing inflammation. In the light of these preliminary results, and because of these specific properties, we decided to perform the clinical observation, before and after therapy, of a local subdermal administration of PDRN in lichen sclerosus genital lesions, focusing on the anti-inflammatory and positive regenerative effects of this A2A adenosine receptor. After 4 months of therapy, according to IGA and DLQI assessment, all patients (group A; n = 14) treated with PDRN + CP showed drastic improvement of the various signs of the disease, related to different aspects of LS, such as hypertrophy, atrophy, leukoplakia, erosion, pigmentation, and inflammation, as compared to patients (group B; n = 14) treated with topical CP therapy. To evaluate the efficacy of intradermal administration of PDRN in male patients suffering from genital lichen sclerosus in addition to topical 0.05% CP, as compared to administering 0.05% CP without PDRN injection. On site intradermal administration of PDRN, associated with CP 0.05% cream, seemed to be associated with a clinical improvement of lichen sclerosus better than CP used in single therapy
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