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Massimo Milani - One of the best experts on this subject based on the ideXlab platform.

  • efficacy of Betamethasone Valerate foam formulation in comparison with Betamethasone dipropionate lotion in the treatment of mild to moderate alopecia areata a multicenter prospective randomized controlled investigator blinded trial
    International Journal of Dermatology, 2003
    Co-Authors: Giuseppe Mancuso, Antonella Balducci, Chiara Casadio, Paolo Farina, Mauro Staffa, Lorenzo Valenti, Massimo Milani
    Abstract:

    Background Betamethasone Valerate foam (BVF) is a new topical corticosteroid formulation. In scalp psoriasis patients BVF has induced a significantly greater clinical improvement in comparison with corticosteroid lotions. No data are available to date regarding the efficacy and safety of BVF in mild-to-moderate alopecia areata (AA). Study aim To evaluate the efficacy, tolerability and safety of BVF treatment in patients with mild-to-moderate AA. Subjects and Methods Sixty-one patients (26 men and 35 women; mean age 41 ± 13 years) with mild-to-moderate AA (hair loss < 26%) were enrolled in a parallel-group, investigator-blinded trial. Subjects were assigned randomly to BVF (31 patients) or to Betamethasone dipropionate lotion (BDL) (30 subjects). Both treatments were applied to the affected areas twice a day for 12 consecutive weeks. Outcomes The primary study outcome was to compare the hair regrowth rate. Efficacy was evaluated at weeks 8 and 12 and at follow up (week 20), using a hair regrowth score (RGS) with a scale ranging from 0 (regrowth  75%). Results Fifty-seven subjects (93%) completed the trial. At week 20, the RGS was 3.1 ± 1.5 and 1.8 ± 1.6 in the BVF and BDL groups, respectively (P   3 was observed in 61% of patients in the BVF group (19/31) in comparison with 27% (8/30) in the BDL group (P < 0.03). No serious adverse events were observed in both groups during the study. Conclusion Betamethasone Valerate foam has shown to be an effective and well-tolerated treatment of mild-to-moderate AA. Further trials are warranted to evaluate the role of this new formulation in comparison or in combination with intralesional corticosterioids in AA treatment.

  • efficacy of Betamethasone Valerate 0 1 thermophobic foam in seborrhoeic dermatitis of the scalp an open label multicentre prospective trial on 180 patients
    Current Medical Research and Opinion, 2003
    Co-Authors: Massimo Milani, Sabino Antonio Di Molfetta, Raffaele Gramazio, Carmen Fiorella, Costantino Frisario, Ernesto Fuzio, Vincenzo Marzocca, Maria Zurilli, Giovanni Di Turi, Giovanni Felice
    Abstract:

    SUMMARYBackground: Seborrhoeic dermatitis (SD) is a common chronic inflammatory disease of the skin. Topical steroid creams and/or antifungal agents are commonly used in SD, but no resolutive therapies have been available up to now. Furthermore, little data have been available regarding clinical outcomes after cessation of topical treatments. A new formulation of Betamethasone Valerate 0.1% in a thermophobic, low-residue, foam vehicle (Bettamousse ) (BVM) has become available for the topical treatment of scalp dermatoses. No data have been published hitherto regarding efficacy, safety and patient acceptability of this new formulation for the treatment of SD of the scalp. * Bettamousse is a registered trademark of Mipharm, ItalyStudy aim: To assess in an open-label, prospective, multicentre trial, the efficacy, safety and patient acceptability of BVM, as compared to baseline, in SD subjects with scalp involvement.Patients and methods: A total of 180 patients with moderate-to-severe SD of the scalp were enr...

  • efficacy of Betamethasone Valerate mousse in comparison with standard therapies on scalp psoriasis an open multicentre randomized controlled cross over study on 241 patients
    British Journal of Dermatology, 2003
    Co-Authors: L Andreassi, Alberto Giannetti, Massimo Milani
    Abstract:

    Summary Background  The scalp is a common area for plaque psoriasis. Corticosteroid-based lotions are the most widely used therapy in this clinical setting. A new formulation of Betamethasone Valerate 0·12% in a thermophobic, low-residue foam vehicle (Bettamousse™, Mipharm, Italy; BVM) is available for the treatment of scalp dermatoses. Objectives  In an open, investigator-blinded, multicentre (28 dermatology clinics), randomized, cross-over study, the efficacy, safety and patient acceptability of BVM in scalp psoriasis were evaluated in comparison with standard therapies (ST, i.e. corticosteroids or vitamin D analogues). ST were chosen by each centre according to its usual therapeutic protocols. Methods  In total, 241 patients with moderate to severe scalp psoriasis participated in the trial. After a 2-week run-in period, each active treatment (BVM or ST) was applied for 4 weeks, with a wash-out period between the two active treatment phases of at least 4 weeks. Efficacy was evaluated by investigators unaware of treatment sequence analysing a ‘target’ lesion for erythema, scaling, itching and burning using a five-point grading score. Patient treatment acceptability and assessment of the influence on Psoriasis Disability Index were evaluated using an eight-item modified Finlay–Khan questionnaire at baseline and at the end of each treatment period. Safety was evaluated by recording any adverse event occurring during the study duration. BVM was applied twice daily, and ST were applied once or twice daily, according to the approved scheduled regimens. Results  Analyses were by intention-to-treat. Two hundred and ten patients concluded the study. Fifteen patients withdrew from the study during BVM treatment, and 16 during ST (not significantly different). Both treatments were well tolerated. At baseline, the mean ± SD clinical global score (the ‘Sum’ score = erythema + scaling + itching + burning) was 7·6 ± 2·6. The ST chosen were topical corticosteroids (55% of cases; mainly mometasone and Betamethasone dipropionate) or calcipotriol lotion (45% of cases). At the end of active treatments, BVM was significantly superior to ST (P < 0·001) in reducing, as compared with baseline, the mean ± SD Sum score (1·5 ± 1·9 with BVM and 3·1 ± 2·7 with ST). During BVM treatment, 88% (95% confidence interval, CI 82–94%) of patients had a complete or nearly complete resolution of scaling in comparison with 66% (95% CI 58–74%) during ST therapy (P < 0·001). BVM was also considered an easier and more convenient formulation to use in comparison with ST (P < 0·01). Conclusions  BVM is more effective than lotion-based ST commonly used in the treatment of scalp psoriasis, and has higher patient acceptability.

Luigi Naldi - One of the best experts on this subject based on the ideXlab platform.

  • Betamethasone Valerate dressing is non inferior to calcipotriol Betamethasone dipropionate ointment in the treatment of patients with mild to moderate chronic plaque psoriasis results of a randomized assessor blinded multicentre trial
    Journal of The European Academy of Dermatology and Venereology, 2014
    Co-Authors: J P Ortonne, Sergio Chimenti, Luigi Naldi, M Esposito, M Kapinskamrowiecka, A Grodzinska, V Frangione
    Abstract:

    Background A ready-to-use Betamethasone Valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP). Methods This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol–Betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients’ quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group. Results Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a −0.288 (95% CI: −0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group. Conclusions BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients’ psoriasis and QoL.

  • efficacy and safety of the Betamethasone Valerate 0 1 plaster in mild to moderate chronic plaque psoriasis a randomized parallel group active controlled phase iii study
    American Journal of Clinical Dermatology, 2011
    Co-Authors: Luigi Naldi, Nikhil Yawalkar, Andrzej Kaszuba, Jeanpaul Ortonne, Paolo Morelli, Stefano Rovati, Giuseppe Mautone
    Abstract:

    Background: Corticosteroids are a versatile option for the treatment of mild-to-moderate psoriasis due to their availability in a wide range of potencies and formulations. Occlusion of the corticosteroid is a widely accepted procedure to enhance the penetration of the medication, thereby improving its effectiveness. Betamethasone Valerate (BMV) is a moderately potent corticosteroid that is available as a cream, ointment, and lotion. A ready-to-use occlusive dressing, which provides a continuous sustained release of BMV, has been developed for the treatment of psoriasis.

Giuseppe Mautone - One of the best experts on this subject based on the ideXlab platform.

Chung Cheng Wang - One of the best experts on this subject based on the ideXlab platform.

  • highly potent and moderately potent topical steroids are effective in treating phimosis a prospective randomized study
    The Journal of Urology, 2005
    Co-Authors: Stephen Sheidei Yang, Yao Chou Tsai, Shihping Liu, Chung Cheng Wang
    Abstract:

    Purpose: We report a prospective randomized study comparing the effects of highly potent and moderately potent topical steroids in treating pediatric phimosis. Materials and Methods: A total of 70 boys 1 to 12 years old with phimosis were randomly assigned to receive topical application of either Betamethasone Valerate 0.06% (a highly potent steroid) or clobetasone butyrate 0.05% (a moderately potent steroid). Parents of the boys were instructed to retract the foreskin gently without causing pain, and to apply the topical steroids over the stenotic opening of the prepuce twice daily for 4 weeks, then for another 4 weeks if no improvement was achieved. Retractibility of the prepuce was graded from 0 to 5. Response to treatment was arbitrarily defined as improvement in the retractibility score of more than 2 points. Results: Mean treatment and followup periods were 4.3 and 19.1 weeks, respectively. The response rates in boys treated with Betamethasone Valerate and clobetasone butyrate were 81.3% and 77.4%, respectively (p 0.63). Mean retractibility score decreased from 3.9 1.0 to 1.7 1.1, and 4.2 1.0 to 1.9 1.0 in the Betamethasone and clobetasone groups, respectively. Both steroids were effective in all age groups. Pretreatment retractibility score did not affect treatment outcomes. No adverse effect was encountered. Conclusions: Highly potent and moderately potent topical steroids are of comparable effectiveness in treating phimosis. A less potent steroid may be considered first to decrease the risk of the potential adverse effects.

H Overgaardpetersen - One of the best experts on this subject based on the ideXlab platform.