Efficacy of Betamethasone Valerate 0.1% Thermophobic Foam In Seborrhoeic Dermatitis of the Scalp: An Open-Label, Muticentre, Prospective Trial on 180 Patients

Massimo Milani, Sabino Antonio Di Molfetta, Raffaele Gramazio, Carmen Fiorella, Costantino Frisario, Ernesto Fuzio, Vincenzo Marzocca, Maria Zurilli, Giovanni Di Turi, Giovanni Felice

Disclosures

Curr Med Res Opin. 2003;19(4) 

In This Article

Abstract and Introduction

Background: 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.
Study 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 enrolled in the trial. Efficacy was evaluated by analysing SD lesions for erythema, scaling and itching using a five-point grading score (0 = lesion completely cured; 1 = mild; 2 = moderate; 3 = severe and 4 = very severe lesion). The clinical global (sum) score was obtained adding the score of each item. Efficacy and safety were assessed at baseline, after 4 weeks of active treatment, followed by an 8-week follow-up period with no treatment.
Results: In comparison with baseline, BVM significantly improved SD lesions. The sum score was reduced from 6.3 ± 1.8 to 1.4 ± 1.4 at the end of the active treatment period, (p < 0.0001) and to 1.7 ± 1.8 at the end of the 8-week follow-up period (p < 0.0001). After active treatment, 93% of the patients had a sum score of ≤ 3). At the end of 8-week of follow-up, 88% of patients maintained a sum score ≤ 3. In addition, 85% of patients considered BVM foam to be a better topical formulation both in terms of efficacy and acceptability compared with previous treatments used.
Conclusion: BVM is an effective and well-tolerated topical treatment of scalp SD. Its clinical effect is also maintained after a 2-month wash-out period.

Seborrhoeic dermatitis (SD) is a common chronic inflammatory disease of the skin.[1] It is characterised by red scaly lesions predominantly located in regions rich in sebaceous glands such as the scalp, face and upper trunk. Pityrosporum ovale is probably the causative agent.[2] SD tends to persist into adulthood, but it often undergoes periods of remission and exacerbation. There is no definitive cure for this clinical condition. Topical products such as steroids[3] and/or antifungal agents are commonly used but only non-resolutive therapies are available so far. Mild corticosteroids are effective in the treatment of SD;[4] however, the disease recurs quickly, often within just a few days. Betamethasone valerate is a medium-potency glucocorticoid molecule used in the treatment of corticosteroid-responsive dermatoses. Betamethasone for topical application is currently available in three formulations: cream, ointment and lotion. A new formulation of betamethasone valerate 0.1% in a thermophobic, low-residue, high-bioavailability foam vehicle (Bettamousse*) (BVM) is now available for the treatment of scalp dermatoses.[5] Controlled randomised trials have demonstrated that BVM is clinically superior to betamethasone valerate and betamethasone dipropionate lotions in scalp dermatoses such as psoriasis[6] and alopecia areata. However, no clinical data have previously been available regarding the efficacy, safety and patient acceptability of this new formulation for the treatment of SD of the scalp.

In an open-label, 3-month, prospective, multicentre trial, the efficacy, safety and patient acceptability of BVM, as compared to baseline, in scalp SD were evaluated. Efficacy and safety were assessed at baseline (T0), after 4 weeks of active treatment (T1) and after an 8-week follow-up period with no active treatment (T2).

The study protocol was approved by local ethics committees and all patients gave oral informed consent. Nine second-level specialist dermatological clinics participated in the trial. Starting from September 2001, a total of 180 patients with moderate-to-severe scalp SD were enrolled. Enrolment was concluded in April 2002. Study inclusion criteria were: men and women, aged 18-70 years, with moderate-to-severe SD with an involvement of at least 15% of the scalp. Exclusion criteria were the following: clinical evidence of bacterial infections of the skin, previous (< 2 weeks) therapies with antimycotic drugs, corticosteroids or antibacterial agents, pregnancy or lactation, Parkinson's disease and/or plasma creatine > 2 mg/day, a positive history of allergic dermatitis to corticosteroids. Efficacy was evaluated by analysing SD lesions for erythema, scaling and itching using a five-point grading score (0 = lesion completely cured, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe lesion). The clinical global (sum) score was obtained by adding the score of each item (i.e.= erythema + scaling + itching). Moderate-to-severe disease was defined as an involvement of at least 15% of the scalp and a minimum sum score of 5. No topical or systemic treatment with antimycotics, corticosteroids or immunosuppressive drugs, as well as medicated shampoo, was allowed for 2 weeks prior to the study start and for the entire study duration (3 months). The primary endpoint of the study was to evaluate the effects of BVM on the clinical global score of erythema, scaling and itching. The secondary endpoint of the study was to assess the efficacy of the treatment 2 months after stopping the application of the foam. Spontaneously reported side-effects were recorded on a case report form using the WHO scale (grade 1 = mild; grade 2 = moderate; grade 3 = severe; grade 4 = serious).

The sample size was based on the assumption of an absolute difference of 0.5 ± 1.4, in the clinical global score in favour of BVM versus the baseline values. With a power of 95% and a type I error of 0.05, at least 164 patients needed to be recruited for the trial. The Wilcoxon signed ranks test, the Friedman test and the paired t-test were used to compare continuous variables. The Fisher exact test was used to compare categorical variables. A p-value of < 0.05 was considered significant. All tests were two-tailed.

A total of 180 patients with moderate-to-severe SD were enrolled in the trial. Study treatment was betamethasone valerate 0.12% foam (Bettamousse, Mipharm, Italy). Clinical evaluations were performed at baseline (T0), after 1 month of BVM treatment (T1) and after 2 months of follow-up without active treatment (T2). The treatment schedule was an application of 2 g of BVM foam to the scalp once daily for 15 days and 2 g every other day for an additional 15 days. After the 1 month of therapy and 2 months of follow-up without treatment, every patient was evaluated for safety and efficacy.

*Bettamousse is a registered trademark of Mipharm, Italy

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