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

Results

Between September 2001 and June 2002, 320 out-patients with SD of the scalp were screened for the study. A total of 180 patients (84 men and 96 women, age mean ± SD: 44 ± 14 years) were enrolled in the trial. Table 1 reports patients' main characteristics at baseline. Eleven patients (6.1%) prematurely withdrew from the study. For patients who concluded the trial prematurely, the LOCF (last observation carried forward) method was utilised.

In comparison with baseline, the results were statistically significant: the sum score for efficacy was reduced from 6.3 ± 1.8 to 1.4 ± 1.4 at the end of the active treatment period, (p < 0.0001; 95% CI of the difference = -5.2/-4.4) and to 1.7 ± 1.8 at the end of the 8-week follow-up period (p < 0.0001; 95% CI of the difference = -5.0/-4.1). No statistically significant differences were found between the end of the active treatment period and the end of the follow-up period. Table 2 shows the evolution of erythema, scaling, itch and sum scores from baseline (T0) to T1 and T2. After active treatment, 93% of patients had a sum score of ≤ 3. At the end of the 8-week of follow-up, 88% of patients continued to have a sum score of ≤ 3. Only 5.7% of patients presented with a relapse of SD (sum score >6) at the end of the follow-up. In addition, 85% of patients considered BVM foam to be a better topical formulation, both in terms of efficacy and acceptability, in comparison with previous treatments used.

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