Efficacy of betamethasone valerate 0.1% thermophobic foam in seborrhoeic dermatitis of the scalp: an open-label, multicentre, prospective trial on 180 patients.
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.


OBJECTIVE
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.


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.


CONCLUSIONS
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.
Milani
Massimo
M
R&D Mipharm, Milan, Italy. massimo.milani@mipharm.it
Antonio Di Molfetta
Sabino
S
Gramazio
Raffaele
R
Fiorella
Carmen
C
Frisario
Costantino
C
Fuzio
Ernesto
E
Marzocca
Vincenzo
V
Zurilli
Maria
M
Di Turi
Giovanni
G
Felice
Giovanni
G
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001624:Betamethasone Valerate / Q000627:therapeutic use*; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012535:Scalp
D000893:Anti-Inflammatory Agents; D001624:Betamethasone Valerate