Pictorial Representation of Illness and Self-Measure to assess the perceived burden in patients with chronic inflammatory vulvar diseases: an observational study.

BACKGROUND: Chronic inflammatory vulvar diseases can have a huge detrimental impact on patient welfare. A few studies have addressed this issue so far, mainly measuring patients' quality of life or sexual dysfunction. OBJECTIVE: To assess the burden of suffering in patients with chronic inflammatory vulvar diseases using the Pictorial Representation of Illness and Self-Measure (PRISM), a visual, non-verbal instrument. We also assessed (i) the concordance between PRISM and the Dermatology Life Quality Index (DLQI), (ii) whether some variables, both patient-related and disease-related, affect the patient's suffering and quality-of-life impairment. METHODS: We evaluated for inclusion in this cross-sectional study all patients who attended our Vulva Unit over a 9-month period with histologically proven lichen sclerosus (LS), lichen planus (LP), lichen simplex chronicus (LSC), eczema, plasma cell vulvitis and psoriasis (at least five for each disease). Demographics and disease-related subjective and objective scores were recorded. The PRISM and DLQI were administered. RESULTS: We included 87 patients affected with LS, 13 with LSC and seven with LP. Median PRISM values (0-273 mm) ranged from 95 to 120 mm, depending on the disease, and median DLQI scores (0-30) were five for all three groups. Neither PRISM nor DLQI scores differed significantly among the three groups. Moderate coherence was found between PRISM and DLQI (ρ = 0.5455, P < 0.001). Global subjective score was the only variable significantly associated with the degree of suffering and quality-of-life impairment. CONCLUSIONS: Pictorial Representation of Illness and Self-Measure proved to be a valuable, highly reliable tool for measuring the perceived burden in these patients. In spite of a moderate correlation, PRISM resulted more sensitive in capturing patient distress than DLQI.

Clearance in vulvar lichen sclerosus: a realistic treatment endpoint or a chimera?

BACKGROUND: According to the current guidelines, the aim of vulvar lichen sclerosus (VLS) treatment was to improve symptoms and signs, not to cure. OBJECTIVE: To assess (i) the rate of patients with VLS who achieved complete clearance of symptoms or objective features, or both, with a 12-week pharmacological treatment and (ii) the predictive value of therapeutic response to the demographic and clinical features. METHODS: We retrospectively included patients with VLS who had undergone any topical treatment for 12 weeks; demographics, history, VLS-related symptoms and objective features recorded at baseline and on completion of treatment were collected and elaborated. The primary study endpoint was to assess the rate of patients achieving complete clearance of global subjective score (GSS), or in global objective score (GOS), and in both scores. RESULTS: One hundred and ninety-six patients were included; 24 (12.2%) were asymptomatic at baseline, and nine (4.6%) dropped out. After treatment, 78 patients (47.3%) achieved GSS = 0, 40 (21.4%) achieved GOS = 0, and 23 (13.9%) achieved complete clearance of both symptoms and signs. Lower symptom scores at baseline and shorter disease duration were associated with the achievement of symptom clearance at the end of the treatment. Earlier disease onset, diagnosis and beginning of study treatment as well as lower baseline GOS were significantly associated with complete recovery of VLS signs and clearance of both symptoms and signs. CONCLUSION: A relevant part of patients who undergo a 12-week topical treatment is not completely cured of VLS. It may be hypothesized that these patients, in spite of a significant improvement, may still have substantial residual disease and, as a result, its effect on their quality of life.

In vivo monitoring of topical therapy for acne with reflectance confocal microscopy.

BACKGROUND: Acne vulgaris is a common disease of the pilosebaceous unit. The aim of the study was to evaluate compartment-specific treatment action through the microscopic non-invasive imaging of skin changes. METHODS: Mild-moderate acne patients, that were prescribed a topical anti-acne product, were followed by clinical and reflectance confocal microscopy (RCM) imaging every 14 days to 6 weeks. Mean and standard deviation of the scores were analyzed for each time point. RESULTS: After 2 weeks, the RCM count of papules/pustules and the RCM scores of exocytosis and dermal inflammation, decreased substantially. After 4 weeks, the RCM number of comedos was reduced. After 6 weeks, the number of regular follicles increased, while the infundibula with thickened bright border decreased significantly. CONCLUSION: The progressive reduction in the clinical scores was correlated with the improvement of the RCM parameters. RCM study of acne skin showed a different timing for inflammatory and hyperkeratotic components to achieve a significant reduction during topical therapy with the association of retinoid and antibacterial molecules. The microscopic changes observed showed the regularization of the skin and the improvement of acne related features. RCM may represent a useful tool for the objective assessment of treatment efficacy and individual response evaluation.

New insights into potential risk factors and associations in genital lichen sclerosus: Data from a multicentre Italian study on 729 consecutive cases.

BACKGROUND: Limited data are available on risk factors associated with lichen sclerosus and no data are available on gender differences in genital lichen sclerosus (GLS). OBJECTIVE: This multicentre study aimed at identifying potential risk factors for GLS, through data collection from a large, mixed-sex sample of patients comparing gender-related differences in relation to data from the general population. METHODS: This was a cross-sectional study on 729 subjects (53.8% females, 46.2% males) affected with GLS, consecutively observed within a network of 15 Italian dermatology units. The following information was collected: demographic data, anthropometric measures, comorbidities, family history of LS, clinical features and symptoms related to GLS. RESULTS: Overweight and obesity, blood hypertension, hypothyroidism and an educational attainment equal or above upper secondary school level were more frequent among the study patients than among the general Italian population. Moreover, a family history of GLS was reported more frequently than expected among GLS patients. These factors were similar in males and females. The disease tended to occur later in females than in males. CONCLUSIONS: Our findings suggest that metabolic factors, and possibly a sedentary lifestyle, may play a role in GLS pathogenesis in genetically predisposed patients, and that risk profile is similar in males and females despite some difference in the onset of symptoms.

Clobetasol propionate vs. mometasone furoate in 1-year proactive maintenance therapy of vulvar lichen sclerosus: results from a comparative trial.

BACKGROUND: Twice-weekly proactive application of mometasone furoate 0.1% ointment (MMF) over 52 weeks was found to be an effective and safe therapy option in maintaining vulvar lichen sclerosus (VLS) remission and in preventing relapse. OBJECTIVE: To assess and compare the effectiveness and safety of two different topical corticosteroids, clobetasol propionate 0.05% ointment (CP) and MMF, administered twice weekly as a maintenance therapy of VLS previously stabilized with a topical corticosteroid course. METHODS: Forty-eight patients affected with VLS who had responded to therapy with either CP or MMF in an earlier 12-week randomized active treatment phase trial were enroled in a 52-week maintenance phase (MP) to apply their previous treatment twice weekly. The main efficacy parameters were the relapse rate, the mean time of relapse, and the change in symptom and sign severity throughout MP. RESULTS: By the end of the 52-week MP, 2 (8.33%) subjects among the CP patients and 1 (4.17%) among the MMF patients experienced a relapse; among relapsing patients the mean time to relapse was 30 weeks. Neither subjective nor objective scores changed significantly during MP among CP and MMF patients. No significant differences were found in any of the assessed efficacy endpoints between CP and MMF. Both treatments were well tolerated and the proactive regimen was judged as convenient by patients. CONCLUSIONS: Proactive application of the ultra-potent CP and the potent MMF was found to be an effective, safe and suitable maintenance treatment for long-term management of VLS. There were no differences between the two corticosteroids.

Hidradenitis suppurativa: guidelines of the Italian Society of Dermatology and Venereology (SIDeMaST) for the use of anti-TNF-α agents.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by nodules, abscesses and sinus tracts, primarily affecting the intertriginous areas. The occlusion of the upper part of the folliculopilosebaceous unit, leading to rupture of the sebofollicular canal with the consequent development of perifollicular lympho-histiocytic inflammation, is believed to be the initial pathogenic event in HS. Giving the chronic nature of HS, its destructive impact on social, working and daily life of patients, its management is often frustrating both for patients and physicians. The HS treatment choices are influenced by disease severity and its individual subjective impact. In this article, the Board of the Italian Society of Dermatology and Venereology (SIDeMaST) on HS has prepared a document focusing on the role of biologic drugs (anti-TNF-α) in HS management, providing also a flow-chart for HS handling and the inclusion and exclusion criteria for HS treatment with anti-TNF-α.

Continuous vs. tapering application of the potent topical corticosteroid mometasone furoate in the treatment of vulvar lichen sclerosus: results of a randomized trial.

BACKGROUND: Topical corticosteroids are the first-line treatment for vulvar lichen sclerosus (VLS). However, evidence on the most appropriate treatment regimen is lacking. OBJECTIVES: To compare the effectiveness and tolerability of tapering vs. continuous application of mometasone furoate (MMF) 0·1% ointment in the treatment of active VLS. METHODS: Sixty-four patients with VLS who enrolled in a 12-week active treatment phase were randomized to apply MMF either (i) once daily for 5 days per week for 4 weeks, then on alternate days for 4 weeks, then twice weekly for 4 weeks (group A) or (ii) for five consecutive days per week for the entire treatment duration (group B). The efficacy parameters were the response rate, the proportion of patients achieving an improvement from baseline of ≥ 75% in subjective and objective scores, and the mean reduction in subjective and objective scores. RESULTS: By the end of the active treatment phase, 27 patients (84%) were considered to be responders in group A, and 25 patients (78%) in group B; 69% and 47% of patients in group A and 62% and 28% in group B achieved ≥ 75% improvement in subjective and objective scores, respectively. The decreases in mean symptom and sign scores were significant compared with baseline with both regimens. No significant differences were found in any of the assessed efficacy end points between the two treatment protocols. Both regimens were well tolerated. CONCLUSIONS: Both tapering and continuous application of MMF showed similar efficacy and tolerability in the treatment of active VLS, without any difference in patient adherence to therapy.

Is hormonal treatment still an option in acne today?

Hormonal treatment is indicated in cases of papulopustular, nodular and conglobate acne in females with identified hyperandrogenism, in adult women who have monthly flare-ups and when standard therapeutic options are unsuccessful or inappropriate. This review summarizes the latest information on hormonal therapies including: combined oral contraceptives; anti-androgens, such as cyproterone acetate, spironolactone and flutamide; low-dose glucocorticoids and gonadotropin-releasing hormone agonists. It also shares the authors' recommendations for treatment based on the studies discussed here, and personal experience.

Growing evidence for topical mometasone fuoroate in the treatment of Vulvar Lichen Sclerosus.

Vulvar lichen sclerosus (VLS) is a chronic inflammatory disease with a huge impact on a person's quality of life. On the basis of the immunologic changes in VLS, treatment with a high potency topical corticosteroid is recommended. The currently available guidelines identified the ultra-potent corticosteroid clobetasol propionate 0.05% (CP) as the first-line recommended treatment but growing evidence supports the use of the potent corticosteroid mometasone furoate 0.1% (MMF). We reviewed the available studies assessing MMF in the treatment of VLS. Both non comparative and comparative studies were included in this review. Findings from clinical trials indicate that MMF is an effective and safe option in the treatment of VLS both in the active phase and in long-term maintenance treatment. Consistent with the findings from the comparative studies, MMF shows similar efficacy and safety to CP.

Avocado and soybean extracts as active principles in the treatment of mild-to-moderate vulvar lichen sclerosus: results of efficacy and tolerability.

OBJECTIVE: Limited evidence is available on the effectiveness of treatments alternative to corticosteroids for vulvar lichen sclerosus (VLS). The present study aimed to assess the efficacy and tolerability of avocado and soybean extracts (ASE) as active principles of both a topical product and a nutritional supplement in the treatment of active mild-to-moderate VLS. MATERIALS AND METHODS: Twenty-three patients were enrolled. Treatment consisted of a topical product containing ASE and other lenitive and anti-oxidant principles administered twice daily for 24 weeks, in association with a dietary supplement containing ASE, vitamin E and para-aminobenzoic acid for the first 12 weeks. The primary efficacy endpoint was the rate of patients achieving an improvement from baseline in global subjective score (GSS) and global objective score (GOS) of ≥ 75%. Secondary efficacy endpoint was the rate of patients achieving GSS50 and GOS50. Tertiary efficacy endpoint was the mean reduction in subjective and objective scores throughout the treatment. RESULTS: By the end of the 24-week treatment, 12 (70.5% of symptomatic patients) and 13 patients (72.2%) achieved an improvement of at least 75% in subjective and objective global scores, respectively; 100% and 88.9% reached GSS50 and GOS50, respectively. Mean symptom and sign scores decreased significantly after treatment. The treatment was well tolerated. CONCLUSIONS: Our results provide evidence that the topical and dietary supplements used in the study, which contain active principles exerting anti-inflammatory, anti-fibrotic, emollient and lenitive actions, are effective alternatives in the treatment of symptoms and signs of mild-to-moderate VLS.

Malignant melanoma in Ferrara, Northern Italy: epidemiologic survey focusing on tumor thickness.

AIM: Estimates of malignant melanoma (MM) incidence and prognosis vary widely. The present study was performed to analyze epidemiologic and prognostic aspects of primary MM mainly in relation to tumor thickness. METHODS: We conducted a retrospective study on a cohort of 435 patients with diagnosis of primary MM between 1997 and 2011. RESULTS: In the period 2009-2011, among the MM diagnosed 50.00% were thin, 32.43% in situ and 17.57% thicker while in 1997-1999 MM>1 mm accounted for 51.61% of diagnoses. Mean age of patients affected with thin MM was significantly lower than that of patients with MM>1 mm, and mean thickness resulted significantly lower in female patients than in males. Mean thickness of MM located on easily self-evaluable body areas was significantly lower than in those not accessible for skin self-examination. The commonest histogenetic type was superficially spreading melanoma. Mitotic rate, ulceration and vertical growth phase all resulted related to MM thickness. Out of 61 patients with thin MM who underwent SLNB, 3 resulted positive (4.92%): neither thickness >0.75 mm, nor ulceration, mitotic rate or Clark level were found to be associated with SLNB positivity. Five-year survival rate was 98.3% for thin MM patients and 76.4% for thick MM patients. CONCLUSION: Our trend analysis evidences a continuing increase of thinner primary MM throughout the study period, potentially enhancing patient prognosis. Regular skin self-examination could contribute to earlier recognition of MM. Identification of more powerful predictors of thin MM prognosis is necessary.

Acne: in vivo morphologic study of lesions and surrounding skin by means of reflectance confocal microscopy.

BACKGROUND: Acne vulgaris is a common disease of the pilosebaceous unit, clinically showing alteration of the keratinization process leading to comedos formation and subsequent inflammatory process. OBJECTIVE: To characterize the morphology of acne lesions and pilosebaceous units by means of in vivo reflectance confocal microscopy, in order to non-invasively define the microscopic alterations occurring during the acne process. METHODS: A set of standardized clinical pictures and a set of reflectance confocal images were acquired from 25 volunteers, presenting mild-to-moderate acne, and 10 healthy volunteers, using Vivascope 3000, and 10 mosaics on apparently normal skin were acquired by 5 acne patients and 5 healthy volunteers by Vivascope 1500, and evaluated by experts. RESULTS: Confocal microscopy enabled to identify morphological aspects characterizing different types of acne lesions. Apparently normal skin of acne patients, compared with healthy skin of patients with no history of acne, revealed peculiar confocal features, such as bright rings around hair follicle that may represent the early events in acne lesion formation. CONCLUSION: The fast and reliable characterization of acne lesions and identification of subclinical alterations in acne-prone skin through confocal examination, corresponding to infundibular hyper-keratinization, may have important clinical consequences in the assessment of acne severity, therapeutic decisions and treatment efficacy monitoring.

Comparative study on topical immunomodulatory and anti-inflammatory treatments for plasma cell vulvitis: long-term efficacy and safety.

BACKGROUND: Evidence on the treatment of plasma cell vulvitis (PCV) is scarce and comparative studies are lacking. OBJECTIVE: To assess and compare the effectiveness and safety, on a long-term basis, of three topical interventions for the treatment of PCV. METHODS: Retrospectively collected efficacy and safety data of a cohort of PCV patients treated with fusidic acid 2% and betamethasone valerate 0.1% cream fixed combination (FA/BM, 14 patients), clobetasol propionate 0.05% ointment (CP, six patients) and tacrolimus 0.1% ointment (TC, four patients) at different regimens between January 2000 and June 2013 were analysed. Treatment outcome was assessed according to Investigator Global Assessment (i) symptoms and (ii) signs, at 12, 24 and 52 weeks. RESULTS: After 12 weeks, 85% of all patients achieved satisfactory improvement in PCV-related symptoms and maintained the improvement across a 52-week observation period. About 45% achieved a satisfactory result in clinical signs after 12 weeks, without further improvement during the following 9 months. No statistical differences in response were found among treatment groups at 12, 24 and 52 weeks. All study treatments were significantly more effective in improving PCV symptoms rather than clinical signs. With regard to treatment tolerability, one patient (7.1%) in FA/BM group and one (25%) in TC group discontinued the treatment due to local side-effects. CONCLUSIONS: CP, FA/BM and TC are effective and safe in treating PCV, inducing both a rapid improvement of the disease, notably of symptoms, and stabilizing its control.