Peroneal mononeuropathy and polyneuropathy in adolescents with Anorexia Nervosa: a case report and literature review.

Peroneal neuropathy and polyneuropathy are displayed with a variable percentage in subjects affected by eating disorders and in particular by anorexia nervosa. Actually, little is known on features of these complications during the paediatric age. We describe the case of a female adolescent with right peroneal palsy and subclinical polyneuropathy associated with anorexia nervosa (AN). We review previous research about peroneal mononeuropathy and polyneuropathy associated with AN, and we develop a diagnostic and therapeutic protocol to help clinicians recognize and treat these disorders.

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.

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.

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.

Treatment of mild to moderate acne with a fixed combination of hydroxypinacolone retinoate, retinol glycospheres and papain glycospheres.

AIM: A fixed combination of 0.1% hydroxypinacolone retinoate (synthetic esther of 9-cis-retinoic acid), 1% retinol in glycospheres and 2% papain in glycospheres in aqueous gel has been recently introduced into the Italian market in order to reduce the incidence and severity of irritant contact dermatitis caused by topical retinoids, without compromising their efficacy. Primary objectives of this sponsor-free, pilot, open, multicenter study were to evaluate the efficacy and tolerability of this gel in patients with comedonal-papular, mild to moderate acne of the face. METHODS: Ninety-eight Caucasian patients (28 males and 70 females), with an age ranging from 15 to 40 years, were treated with the gel once daily for 12 weeks. Acne severity and treatment efficacy were evaluated by means of the Global Acne Grading System (GAGS) and lesions count. RESULTS: Ninety-four patients were considered evaluable. A 41% mean reduction in the GAGS score was observed; a 40.8% mean reduction of total lesions was recorded; 15.3% of patients experienced mild to moderate local side effects (dryness, peeling, erythema, burning). No patients stopped the treatment because of these side effects. CONCLUSION: This study, based on a high number of evaluable patients, demonstrates that this fixed combination is an effective and safe option for the treatment of comedonal-papular, mild to moderate acne of the face. A controlled clinical study is necessary to confirm these data.

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.

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.

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.

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.

First randomized trial on clobetasol propionate and mometasone furoate in the treatment of vulvar lichen sclerosus: results of efficacy and tolerability.

BACKGROUND: A 3-month topical application of clobetasol propionate (CP) represents the recommended and accepted first-line treatment for vulvar lichen sclerosus (VLS); however, to date, no randomized controlled trials have compared the efficacy and safety of CP with other topical corticosteroids. OBJECTIVE: To compare the effectiveness and tolerability of two different topical corticosteroids, CP 0·05% ointment and mometasone furoate (MMF) 0·1% ointment, in the treatment of VLS. METHODS: Fifty-four patients with VLS were enrolled in a 12-week active treatment phase (ATP) and randomized to apply either CP or MMF in a tapering regimen. The main efficacy parameters were the response rate, the rate of patients achieving an improvement from baseline of ≥ 75% in the subjective and objective scores, and the mean reduction in subjective and objective scores throughout the treatment. RESULTS: By the end of the 12-week ATP, 24 (89%) patients were considered to be responders among the CP patients and 24 (89%) among the MMF patients; 59% and 37% of patients in the CP group and 67% and 48% in the MMF group achieved an improvement of at least 75% in subjective and objective scores, respectively. The decrease in mean symptom and sign scores was significant compared with baseline with both treatments. No significant differences were found in any of the assessed efficacy endpoints between CP and MMF. Both treatments were well tolerated. CONCLUSIONS: Clobetasol propionate and MMF appeared similarly efficacious and well tolerated for the treatment of VLS and both may represent the first-line treatment for the disease.

Mometasone fuoroate 0.1% ointment in the treatment of vulvar lichen sclerosus: a study of efficacy and safety on a large cohort of patients.

BACKGROUND: Guidelines identify a 3-month topical application of an ultra-potent corticosteroid ointment as the mainstay of medical treatment for vulvar lichen sclerosus (VLS). However, there are no trials providing evidence that any specific corticosteroid is superior to another. OBJECTIVE: To assess the effectiveness and safety of a 12-week application of mometasone furoate (MMF) 0.1% ointment, with a tapering regimen, in achieving control of VLS signs and symptoms and to detect potential risk factors for VLS non-response. METHODS: 147 patients affected with VLS were enrolled in a 12-week active treatment phase (ATP) with topical 0.1% MMF. The primary efficacy endpoint was the rate of patients achieving clinical response, as defined by protocol parameters. The secondary efficacy endpoint was to assess the changes of mean VLS-related symptoms after the 12-week ATP compared with baseline. RESULTS: By the end of the ATP, 113 patients (80.7%) experienced a treatment response, whereas 27 women (19.3%) were judged as non-responders. Mean symptom scores decreased significantly in the study patients, regardless of their clinical response at the end of the ATP. Among all the epidemiological and clinical data considered, only the absence of previous medical therapies was found to be related to a significantly higher risk of non-response to treatment. CONCLUSIONS: Application of 0.1% MMF ointment for 12 weeks on a tapering regimen was found to be an effective and safe therapy option in the ATP of VLS and could represent an alternative first-line treatment to an ultra-potent molecule.

Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study.

BACKGROUND: The chronic and relapsing nature of vulvar lichen sclerosus (VLS) represents a challenge for its long-term management after an effective treatment with topical corticosteroids. OBJECTIVES: To assess the effectiveness of proactive, twice-weekly application of mometasone furoate 0·1% ointment, compared with daily topical vitamin E or cold cream, in keeping VLS in remission and reducing the risk of relapse after 3 months of treatment with topical corticosteroid. METHODS: In total, 27 patients affected with VLS were enrolled into a 12-week active treatment phase (AP) with topical mometasone furoate 0·1% ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase (MP) in which patients were randomized to apply either mometasone furoate 0·1% ointment twice weekly, a cold cream once daily or topical vitamin E once daily. The primary efficacy parameters were the relapse rate and the mean time to relapse. RESULTS: Twenty-five patients considered to have been completely or almost completely healed after the AP entered the MP. By the end of the 52-week MP, 10 patients (40%) experienced a relapse: five in the vitamin E group (56%) and five in the cold cream group (62%), while no patient in the mometasone furoate 0·1% ointment group had a relapse. The occurrence of VLS relapse for patients in therapy with both vitamin E and cold cream was significantly higher than for those in proactive therapy with topical corticosteroid. The median time to relapse was the same (21·6 weeks) for the vitamin E and the emollient groups. CONCLUSIONS: Once VLS has been stabilized with topical corticosteroids, twice-weekly proactive application of mometasone furoate 0·1% ointment over 56 weeks was found to be an effective and safe therapy option in maintaining VLS remission and in preventing the occurrence of relapse.

Low-cumulative dose isotretinoin treatment in mild-to-moderate acne: efficacy in achieving stable remission.

BACKGROUND: Aimed at the reduction of post-treatment relapse of severe acne, the cumulative dose of oral isotretinoin should be ≥120 mg/kg. However, data on the appropriate oral isotretinoin treatment regimen in mild and moderate acne are lacking. OBJECTIVE: The purpose of this study was to determine the efficacy of an isotretinoin-sparing protocol in inducing permanent remission of mild and moderate acne. METHODS: In this open, prospective, non-comparative study, 150 patients affected with mild-to-moderate acne were treated with isotretinoin until complete recovery and for a further month of treatment, independent of the total cumulative dose reached. Patients then underwent a 1-year maintenance therapy with adapalene 0.1% cream. Patients were followed up for a further year, without any treatment. RESULTS: A total of 139 patients completed the study. Overall, patients received a mean of 80.92 mg/kg cumulative dose of isotretinoin. In the 2-year follow-up, relapse only appeared in 13 patients (9.35%). CONCLUSION: Comparing our findings with published data, this isotretinoin-sparing regimen was shown to be effective in inducing stable remission and preventing acne relapses in patients with mild-to-moderate acne. Low-cumulative dose regimens may potentially lead to a lower incidence of side-effects and to lower costs than higher doses.

[What's new in acne? New therapeutic approaches]. / Quoi de neuf dans l'acné ? Nouvelles approches thérapeutiques.

Well-known topical and systemic treatments for acne have advanced little over the last 10 years. However, many therapeutic approaches are being evaluated both in terms of topical and systemic treatments. The purpose of this paper is to show the progress of innovative drug projects in treating acne. The topical use of new formulations using lipid nanoparticles and microspheres could help for new products based on anti-androgens or retinoids more concentrated and better tolerated. New active agents such as topical antimicrobial peptides, inhibitors of ectopeptidase, omiganan pentahydrochloride, antisense oligonucleotides, lauric acid are many original ways to explore for the treatment of acne. New treatment regimens for doxycycline and isotretinoin would increase tolerance. Dapsone has been evaluated for isotretinoin-resistant forms. Phototherapy narrowband light (blue or red) can find its place in the strategy for the management of acne. Finally, acne vaccines could be developed too.