{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T17:33:50Z","timestamp":1790098430166,"version":"4.0.1"},"reference-count":19,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2006,10,11]],"date-time":"2006-10-11T00:00:00Z","timestamp":1160524800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2006,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Background\u2002<\/jats:bold> Clinical efficacy of topical corticosteroids in alopecia areata (AA) is still controversial. Positive clinical results have been obtained using ointments with occlusive dressing but this approach has a low patient compliance. Recently, a new topical formulation (thermophobic foam: Versafoam\u00ae) of clobetasol propionate 0.05% has been introduced on the market (Olux\u00ae, Mipharm, Milan, Italy) (CF). This formulation is easy to apply. After application to the skin the foam quickly evaporates without residues and it has a good patient compliance. <jats:italic>In vitro<\/jats:italic> studies have also shown that this formulation enhances the delivery of the active compound through the skin.<\/jats:p><jats:p><jats:bold>Aim\u2002<\/jats:bold> To evaluate the efficacy, safety and tolerability of CF in the treatment of moderate to severe AA.<\/jats:p><jats:p><jats:bold>Subjects and methods\u2002<\/jats:bold> Thirty\u2010four patients with moderate to severe AA (eight men, mean age 40\u00a0\u00b1\u00a013\u00a0years) were enrolled in a randomized, double\u2010blind, right\u2010to\u2010left, placebo\u2010controlled, 24\u2010week trial. Alopecia grading score (AGS) was calculated at baseline and after 12 and 24\u00a0weeks of treatment using a 0\u20135 score (0\u00a0=\u00a0no alopecia; 5\u00a0=\u00a0alopecia totalis). Clobetasol foam and the corresponding placebo foam (PF) were applied twice a day for 5\u00a0days\/week for 12\u00a0weeks (phase 1) using an intrapatient design (right vs. left). From weeks 13 to 24 each enrolled patient continued only with the treatment (both on the right and left site) that was judged to have a greater efficacy than that on the contralateral side (phase 2). The primary outcome of the trial, evaluated on an intention\u2010to\u2010treat basis, was the hair regrowth rate, which was evaluated using a semiquantitative score (RGS) (from 0:\u00a0no regrowth, to 4: regrowth of\u00a0\u00a075%).<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> At baseline the AGS was 4.1 (range: 2\u20135). Nine (26%) patients prematurely concluded the trial. At the end of phase 1, a greater hair regrowth was observed in 89% of the head sites treated with CF vs. 11% in the sites treated with PF. The RGS was 1.2\u00a0\u00b1\u00a01.6 in the CF\u2010treated sites and 0.4\u00a0\u00b1\u00a00.8 in the PF\u2010treated sites (<jats:italic>P\u00a0=<\/jats:italic>\u00a00.001). A RGS of\u00a0\u00a02 (hair regrowth of more than 25%) was observed in 42% CF\u2010treated sites and in 13% of PF\u2010treated sites (<jats:italic>P\u00a0=<\/jats:italic>\u00a00.027). In seven subjects (20%) a RGS of 3 to 4 (hair regrowth of\u00a0\u00a050%) was observed in CF\u2010treated sites. In three subjects (9%) a RGS of 4 (hair regrowth of\u00a0\u00a075%) was observed in CF\u2010treated sites. In one patient only, in a PF\u2010treated region, a RGS of 3 was observed. The AS was reduced to 3.8 by CF treatment at the end of phase 1 and to 3.3 at the end of phase 2 (<jats:italic>P\u00a0=<\/jats:italic>\u00a00.01). From weeks 12 to 24 the treatment with CF induced a further increase in the RGS (from 1.2 to 1.5\u00a0\u00b1\u00a01.4). Forty\u2010seven per\u00a0cent of CF\u2010treated patients had a RGS of\u00a0\u00a02 at the end of the trial. A total of eight patients (25%) at the end of the treatment with CF showed a RGS of\u00a0\u00a03. Folliculitis occurred in two patients. No significant modifications in cortisol and ACTH blood levels were observed during the trial.<\/jats:p><jats:p><jats:bold>Conclusion\u2002<\/jats:bold> This new formulation of clobetasol propionate foam is an effective, safe and well\u2010tolerated topical treatment for AA. 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