mometasone-furoate and Lichen-Sclerosus-et-Atrophicus

Lichen sclerosus is a chronic, inflammatory skin condition that most commonly occurs in adult women, although it may also be seen in men and children. It primarily affects the genital area and around the anus, where it causes persistent itching and soreness. Scarring after inflammation may lead to severe damage by fusion of the vulval lips (labia); narrowing of the vaginal opening; and burying of the clitoris in women and girls, as well as tightening of the foreskin in men and boys, if treatments are not started early. Affected people have an increased risk of genital cancers.. To assess the effects of topical interventions for genital lichen sclerosus and adverse effects reported in included trials.. We searched the following databases up to 16 September 2011: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2007), LILACS (from 1982), CINAHL (from 1981), British Nursing Index and Archive (from 1985), Science Citation Index Expanded (from 1945), BIOSIS Previews (from 1926), Conference Papers Index (from 1982), and Conference Proceedings Citation Index - Science (from 1990). We also searched ongoing trial registries and scanned the bibliographies of included studies, published reviews, and papers that had cited the included studies.. Randomised controlled trials (RCTs) of topical interventions in genital lichen sclerosus.. Two authors independently selected trials, extracted data, and assessed the risk of bias. A third author was available for resolving differences of opinion.. We included 7 RCTs, with a total of 249 participants, covering 6 treatments. Six of these RCTs tested the efficacy of one active intervention against placebo or another active intervention, while the other trial tested three active interventions against placebo.When compared to placebo in one trial, clobetasol propionate 0.05% was effective in treating genital lichen sclerosus in relation to the following outcomes: 'participant-rated improvement or remission of symptoms' (risk ratio (RR) 2.85, 95% confidence interval (CI) 1.45 to 5.61) and 'investigator-rated global degree of improvement' (standardised mean difference (SMD) 5.74, 95% CI 4.26 to 7.23).When mometasone furoate 0.05% was compared to placebo in another trial, there was a significant improvement in the 'investigator-rated change in clinical grade of phimosis' (SMD -1.04, 95% CI -1.77 to -0.31).Both trials found no significant differences in reported adverse drug reactions between the corticosteroid and placebo groups. The data from four trials found no significant benefit for topical testosterone, dihydrotestosterone, and progesterone. When used as maintenance therapy after an initial treatment with topical clobetasol propionate in another trial, topical testosterone worsened the symptoms (P < 0.05), but the placebo did not.One trial found no differences between pimecrolimus and clobetasol propionate in relieving symptoms through change in pruritus (itching) (SMD -0.33, 95% CI -0.99 to 0.33) and burning/pain (SMD 0.03, 95% CI -0.62 to 0.69). However, pimecrolimus was less effective than clobetasol propionate with regard to the 'investigator-rated global degree of improvement' (SMD -1.64, 95% CI -2.40 to -0.87). This trial found no significant differences in reported adverse drug reactions between the pimecrolimus and placebo groups.. The current limited evidence demonstrates the efficacy of clobetasol propionate, mometasone furoate, and pimecrolimus in treating genital lichen sclerosus. Further RCTs are needed to determine the optimal potency and regimen of topical corticosteroids, examine other topical interventions, assess the duration of remission or prevention of flares, evaluate the reduction in the risk of genital squamous cell carcinoma or genital intraepithelial neoplasia, and examine the efficacy in improving the quality of the sex lives of people with this condition.

Topics: Adult; Anti-Inflammatory Agents; Child; Clobetasol; Dermatologic Agents; Dihydrotestosterone; Female; Genital Diseases, Male; Humans; Lichen Sclerosus et Atrophicus; Male; Mometasone Furoate; Pregnadienediols; Randomized Controlled Trials as Topic; Tacrolimus; Testosterone Propionate; Vulvar Lichen Sclerosus

To assess the efficacy and safety of treating vulvar lichen sclerosus with mometasone furoate, a synthetic analogue of beclomethasone.. Thirty-one consecutive patients with biopsy-proven vulvar lichen sclerosus (LS) seen at the Florence Vulvar Clinic were entered into the study. Each subject's symptoms and the gross appearance of the lesions were recorded using a severity score according to the authors' previous studies. The patients were treated with a regimen of 0.1% mometasone furoate cream applications to the affected areas once daily for 4 weeks and then twice weekly for 8 weeks. After 12 weeks of treatment, the subjects were asked to rate the changes in their symptoms and were reevaluated by the same examiner for the gross appearance of the lesions. In every patient the before/after treatment total severity scores were compared using Wilcoxon's signed-rank test for statistical significance.. With mometasone furoate all the patients had a significant improvement (P < .001) in the gross aspects of the disease and a very dramatic decrease in symptoms (P < .001), with nearly all the subjects having complete symptomatic remission. Compliance was excellent, and no side effects were observed.. The improved risk/benefit ratio of mometasone furoate may minimize the possible long-term side effects expected when using a very potent topical steroid. Therefore, momentasone furoate cream may be an alternative to clobetasol propionate for treatment of vulvar LS, with similar efficacy but higher levels of safety and tolerability.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Female; Glucocorticoids; Humans; Lichen Sclerosus et Atrophicus; Middle Aged; Mometasone Furoate; Pregnadienediols; Severity of Illness Index; Treatment Outcome; Vulvar Diseases

Lichen sclerosus (LS) is a disabling chronic inflammatory disease of skin and genital mucous membrane causing itch, pain, dysuria and restriction of micturition, and significant sexual dysfunction and dyspareunia both in women and men. If left untreated, LS is associated with a high degree of sclerosis and scarring, as well as with an elevated risk of cancer in the genital area. Although a central role of autoimmunity is suggested, the pathogenesis of LS is still not clearly understood and the disease remains difficult to treat. The goals of treatment of LS are to alleviate symptoms and discomfort, prevent anatomical changes and prevent malignant transformation. This guideline has been developed by an Italian group of experts. It summarizes evidence-based and expert- based recommendations. The highest level of evidence favors the use of topical high potency corticosteroids; second- and third-line treatments include topical calcineurin inhibitors and topical retinoids, respectively. Surgical treatment has become the treatment of choice in male genital LS with persistent phimosis not responsive to medical treatment. The aim of this paper is to offer evidence-based and easily applicable recommendations for the management of LS.

Topics: Calcineurin Inhibitors; Dermatology; Female; Humans; Italy; Lichen Sclerosus et Atrophicus; Male; Mometasone Furoate

Lichen sclerosus (LS) is a disease of the skin of unclear etiology that can occur in the foreskin. Topical therapy with corticosteroids is recommended, but they can have side effects.. We aimed to compare the effects of ozonides with vitamin E acetate (OZOILE) versus topical corticosteroid in children undergoing circumcision.. Twenty children undergoing circumcision were treated before surgery: 10 children with OZOILE cream and 10 with 0.1% mometasone furoate once a day for 7 days. Ten age-matched patients with LS of the foreskin without any treatment were recruited as controls. Transcript levels of proinflammatory and anti-inflammatory cytokines and e-cadherin were evaluated in removed foreskins by qRT-PCR.. OZOILE and steroid topical treatment produced a similar reduction of TNF-α and IL-1β mRNA levels in foreskins from patients with LS when compared to untreated patients (p < 0.001). OZOILE and steroid treatment caused an increase in the transcript levels of IL-13 and e-cadherin in the foreskin of patients affected by LS in comparison to untreated foreskin (p < 0.001).. On the basis of our biochemical data, a randomized clinical trial might be useful to verify the actual clinical effect of OZOILE as alternative treatment to corticosteroids in children affected by LS of the foreskin.

Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Child; Child, Preschool; Foreskin; Genital Diseases, Male; Humans; Inflammation; Lichen Sclerosus et Atrophicus; Male; Mometasone Furoate; Olive Oil; Ozone; Retrospective Studies; Vitamin E