SIIV position paper: clinical approach to vulval diseases. Need for quality standards.

This paper summarizes the position of the Italian Society of Vulvology on the clinical approach to vulval disease. A thorough history (general medical, gynaecological, and vulval history) is essential for a successful and fruitful vulvological examination. Characteristics of pruritus (itch) and pain, that are the two main vulval symptoms, should be collected and reported with precision, according to duration, temporal course, location, provocation, and intensity. Physical examination must consider both the general condition of the patient and the specific vulval region, that must be examined following a standardized methodology. The physical examination of the vulva is carried out with naked eye and adequate natural or halogen lighting. The subsequent use of instrumental magnification can be considered on particular parts of skin/mucosa, already highlighted with the first inspection. Also, palpation is essential, allowing to appreciate physical features of vulval lesions: consistency, surface, soreness, adherence to underlying plans. Finally, the five-step approach of the International Society for the Study of Vulvo-vaginal Disease about Terminology and Classification of Vulvar Dermatological Disorders (2012) is summarized. A vulval biopsy may be useful in the following situations: when clinical diagnosis is uncertain, lesion not responding to treatment; histologic confirmation for a clinical diagnosis and exclusion or confirmation of a suspected neoplastic intraepithelial or invasive pathology.

Gender differences in genital lichen sclerosus: data from a multicenter Italian study on 729 consecutive cases.

BACKGROUND: Studies specifically conducted to assess gender differences in genital lichen sclerosus (GLS) are not available. This multicenter study aimed to identify possible gender-related differences on GLS clinical features, history and course, through collecting data from a large mixed-sex sample of patients. 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 specifically collected: clinical features and severity of symptoms related to GLS, extragenital involvement, previous therapies, diagnostic suspicion at referral, type of referring physicians, development of genital squamous-cell carcinoma (SCC). RESULTS: Females complained of symptoms more frequent and severe than men; pallor and scarring-sclerosis-atrophy were the most frequent features without gender differences; itching-related signs were more frequent in females than in males as well as extragenital involvement; prior to receiving a definitive diagnosis, females received treatment more frequently than males; 40% of patients were referred with a misdiagnosis; the highest rate of correct suspected diagnosis at referral came from dermatologists than from other physicians; duration of the disease was found to predispose to SCC development. CONCLUSIONS: Our findings highlighted several gender differences on clinical presentation and symptom profile of GLS. In spite of some characteristic features, misdiagnosis at referrals was frequent.

Dyspareunia in vulvar lichen sclerosus: an overview of a distressing symptom.

BACKGROUND: Dyspareunia is a symptom of vulvar lichen sclerosus (VLS). This study specifically addressed prevalence and severity of dyspareunia in patients affected with VLS as well as the factors that can influence its occurrence. Changes in the severity of dyspareunia with treatment were also explored. METHODS: In this retrospective, cohort study we included VLS patients who had undergone any topical treatment for 12 weeks, between January 2011 and March 2016, at our Vulva Unit; demographics, history and clinical features recorded at baseline and at treatment completion were elaborated. RESULTS: The study included 177 patients; among the 90 patients who reported having sexual activity 56.7% complained of dyspareunia; the frequency and severity of dyspareunia was higher among the patients who had not previously been treated with topical corticosteroids than among those who had undergone previous treatments; the patients complaining of dyspareunia reported significantly higher scores for itching and burning compared with those who did not have painful intercourses; after the treatment, 52.5%, 78.4% and 64.3% of the patients reported an improvement ≥75% compared with baseline in dyspareunia, itching and burning scores, respectively. CONCLUSIONS: Dyspareunia occurred in more than half VLS patients. The patients who complained of dyspareunia had a more severe overall symptom profile than those who did not report having painful intercourses. The objective severity of VLS did not seem to significantly affect dyspareunia occurrence and severity. Dyspareunia was found to be the symptom most resistant to treatment, however early treatment can be expected to reduce its occurrence and severity.

Combining topical tretinoin with mometasone furoate in the treatment of vulvar lichen sclerosus: Results of dermoscopic assessment.

The main purpose of the present study was to compare the dermoscopic changes on vulvar lichen sclerosus (VLS) induced by two different 12-week treatment protocols, namely mometasone furoate 0.1% ointment plus tretinoin 0.05% cream in short-contact therapy (group A) versus the same corticosteroid plus emollient (group B). All dermoscopic images captured before and after treatment were assessed. Each dermoscopic variable selected for the study purpose was arbitrarily graded according to a 4-point scale by dermatologists blinded to both the time at which the images were captured and treatment allocation. Seventeen patients in group A and 15 in group B were included. The vessel mean dermoscopic scores increased significantly after treatment, whereas the scores of (a) patchy, structure-less, whitish areas, (b) whitish background, (c) comedo-like openings, and (d) purpuric blotches decreased. At the control visit, the two protocols did not differ significantly for any of the dermoscopic parameters, both in terms of mean score change and in the number of patients showing changes. Although the complementary action of the two molecules may suggest a therapeutic benefit, the association of tretinoin in short contact therapy with a potent corticosteroid did not induce significant changes in the dermoscopic features of VLS compared with the same corticosteroid alone.

Dermoscopy of Inflammatory Genital Diseases: Practical Insights.

Diagnosis of genital inflammatory disorders may be difficult for several reasons, such as their similar appearance, possible misdiagnosis with infectious and malignant conditions, and peculiar anatomic conditions that may lead to modification of clinical features. Dermoscopy could be included as a part of the clinical inspection of genital diseases to support diagnosis, as well as to ideally avoid unnecessary invasive investigation. Practical guidance for the use of dermoscopy in the assessment of the main inflammatory genital diseases is provided, namely for lichen sclerosus, lichen planus, psoriasis, lichen simplex chronicus, and plasma cell mucositis.

Mometasone furoate in the treatment of vulvar lichen sclerosus: could its formulation influence efficacy, tolerability and adherence to treatment?

PURPOSE: To assess the effectiveness, tolerability, and convenience of the cream formulation of mometasone furoate 0.1% (MMF) in the treatment of active vulvar lichen sclerosus (VLS) and to compare the cream with the ointment formulation. METHODS: The following efficacy parameters were assessed in 27 VLS patients treated with MMF cream for 12 weeks (group A): (i) response rate, (ii) percentage of patients achieving an improvement from baseline of ≥75% in subjective and objective scores, and (iii) mean reduction in subjective and objective scores. These efficacy assessments, as well as those regarding safety and adherence, were compared with the assessments recorded among 37 VLS patients treated with MMF ointment (group B). RESULTS: 59.3% (group A) and 78.4% (group B) of patients were considered responders; 44.4% and 40.7% of patients in group A and 54.1% and 45.9% in group B achieved an improvement of at least 75% in subjective and objective scores, respectively. MMF ointment obtained a significantly higher improvement in symptom scores in comparison with the cream formulation. CONCLUSIONS: MMF in ointment formulation seems to be more effective in treating active VLS in comparison with MMF cream. Both formulations are well tolerated and there is no difference in patient adherence and satisfaction.

Impact of socioeconomic status and district of residence on cutaneous malignant melanoma prognosis: a survival study on incident cases between 1991 and 2011 in the province of Ferrara, northern Italy.

The aim of this study was to analyse the impact of socioeconomic status (SES) on the prognosis of patients with invasive malignant melanoma (MM) incident from 1991 to 2011 in the province of Ferrara, northern Italy. A total of 750 patients provided by the Area Vasta Emilia Centrale Cancer Registry were included in this retrospective cohort study. Prognosis was analysed in terms of overall survival and specific survival. The study determinants were the patients' SES and district of residence. The confounding effect of sex, age, period and TNM stage at diagnosis was evaluated. In the study population, neither overall survival nor specific survival showed significant differences among different layers of SES and districts of residence. The risk for death from MM was lower for the female sex [hazard risk (HR)=0.68, 95% confidence interval (CI): 0.50-0.94] and for diagnoses made in the most recent period (2005-2011: HR=0.56, 95% CI: 0.36-0.89 with respect to 1991-1997). A worse prognosis was observed in patients older than 70 years at the time of diagnosis (HR=2.33, 95% CI: 1.39-3.91 with respect to the <40-year age group) and in patients with more than pT1 tumours (up to 20 times for pT4 tumours). SES and district of residence did not constitute prognostic factors for MM patients residing in the province of Ferrara. Homogeneity in MM staging, treatment and follow-up strategies due to the relatively small extent of the study area and the presence of a single university hospital of reference, as well as less marked social and economic differences among the study patients in comparison with other previously analysed populations, may account for this finding.

Glycaemic index, glycaemic load and risk of cutaneous melanoma in a population-based, case-control study.

Glycaemic index (GI) and glycaemic load (GL) are indicators of dietary carbohydrate quantity and quality and have been associated with increased risk of certain cancers and type 2 diabetes. Insulin resistance has been associated with increased melanoma risk. However, GI and GL have not been investigated for melanoma. We present the first study to examine the possible association of GI and GL with melanoma risk. We carried out a population-based, case-control study involving 380 incident cases of cutaneous melanoma and 719 age- and sex-matched controls in a northern Italian region. Dietary GI and GL were computed for each subject using data from a self-administered, semi-quantitative food frequency questionnaire. We computed the odds ratio (OR) for melanoma according to quintiles of distribution of GL and GL among controls. A direct association between melanoma risk and GL emerged in females (OR 2·38; 95 % CI 1·25, 4·52 for the highest v. the lowest quintile of GL score, P for trend 0·070) but not in males. The association in females persisted in the multivariable analysis after adjusting for several potential confounders. There was no evidence of an association between GI and melanoma risk. GL might be associated with melanoma risk in females.

Efficacy and safety of a 12-month treatment with a combination of hydroxypinacolone retinoate and retinol glycospheres as maintenance therapy in acne patients after oral isotretinoin.

BACKGROUND: A correct therapeutic management of acne should include a maintenance therapy to prevent recurrences after discontinuing a successful treatment. The aim of this study is to investigate efficacy and safety of a 12-month maintenance treatment with a product, based on Retinsphere technology that combines retinol encapsulated in glycospheres and hydroxypinacolone retinoate (Biretix gel®), to control acne relapse after a treatment with oral isotretinoin (O.I.). METHODS: The study consisted of 2 phases: active treatment phase (AP) and maintenance phase (MP). In the AP, 40 consecutive patients with moderate facial acne were treated with O.I. until acne remission. Then, the patients entered in the MP and were treated with Biretix gel® once-daily for 12 months. The efficacy parameter was the relapse rate during MP. RESULTS: Thirty-nine patients completed the study. Relapse appeared in 6 patients (15.38%). The new product with Retinsphere technology was well tolerated and none of the subjects complained of adverse events. CONCLUSIONS: Our findings seems to provide favorable evidence of the efficacy and the safety of this new product in the maintenance treatment after O.I. in patient with moderate acne. The efficacy is maintain for a period as long as a year after O.I. suspension.

Combined therapy in vulvar lichen sclerosus: does topical tretinoin improve the efficacy of mometasone furoate?

Abstrract Purpose: To assess efficacy and safety profile of combining a potent corticosteroid with a retinoid in the treatment of vulvar lichen sclerosus (VLS). METHODS: We retrospectively compared 21 VLS patients treated with tretinoin (T) in short-contact therapy and mometasone furoate (MMF) (group A) and 20 treated with cold cream (CC) and MMF (group B) for 5 consecutive days/week for 12 weeks. The efficacy parameters were the response rate, the percentage of patients achieving an improvement from baseline of ≥75% in subjective and objective scores and the mean reduction in subjective and objective scores. RESULTS: Thirteen patients (75.2%) were considered as responders in group A and 15 (78.9%) in group B; 50% and 61.1% of patients in group A and 100% and 63.1% in group B achieved an improvement of at least 75% in subjective and objective scores, respectively. The scheme combining MMF and CC was better tolerated than the combination of MMF and T. CONCLUSIONS: The combination with a topical retinoid did not enhance the effectiveness of a potent corticosteroid in the treatment of VLS. Either the scarce efficacy of the short-contact therapy regimen or a less favorable safety profile of such combination may account for these findings.

Rosacea fulminans or acute rosacea? Report of 5 cases and review of the literature.

Rosacea fulminans, previously called pyoderma faciale, is an inflammatory disease considered a dramatic form of rosacea rather than of acne. Typical features are: exclusive facial involvement of young women, sudden onset of large nodules without other signs of acne, remission without scarring or with minimal scars, no recurrences or systemic symptoms. Oral isotretinoin associated with a short course of systemic and topical corticosteroids represent the recommended treatment. Personal observation of 5 cases has induced us to make a review of worldwide literature in order to better define this clinical entity. In our opinion, rosacea fulminans is a valid diagnosis, but clinical criteria should be rigorously respected to fully exclude rosacea conglobata and acne fulminans.

Contact Sensitization to Emulsifying Agents: An Underrated Issue?

BACKGROUND: The evidence on the safety of topical preparations containing emulsifiers is limited. OBJECTIVES: The aims of the study were to assess (1) the prevalence of sensitization to some emulsifiers commonly found in topical products, (2) the sensitization to emulsifiers in relation to sex, age, and predisposing factors, and (3) the frequency of concomitant sensitization to other common allergens. METHODS: All consecutive patients presenting to the Allergy Unit of our Dermatological Department for allergological investigation were enrolled. All patients were patch tested with the Italian Società Italiana di Dermatologia Allergologica Professionale ed Ambientale baseline series and an additional emulsifiers series. Doubtful patch test reactions were not considered. RESULTS: Of 310 patients, 50 (16%) were sensitized to emulsifiers with 72 positive reactions. Lauryl polyethylene glycol/polypropylene glycol-18/18 methicone gave 26 positive reactions, glyceryl oleate 19, myristyl alcohol, and Amerchol L101 11. Concomitant sensitization to emulsifiers was found in 16 patients. Patients allergic to emulsifiers showed concomitant allergic reactions to allergens commonly found in cosmetics. No significant differences by sex, age, atopic diathesis, and clinical pattern at presentation were noticed. CONCLUSIONS: Contact allergy to emulsifiers is more frequent than reported. Patients allergic to emulsifiers show frequent positive patch tests to other constituents of cosmetics and topical products.