MOMETASONE FUROATE SOLUTION 0.1-PERCENT COMPARED WITH KETOCONAZOLE SHAMPOO 2-PERCENT FOR SEBORRHEIC DERMATITIS OF THE SCALP

This double-masked, randomized, parallel-group, comparative study of p atients with moderate-to-severe seborrheic dermatitis of the scalp com pared the efficacy of mometasone furoate solution 0.1% (MFS) once dail y with ketoconazole shampoo 2% (KS) used twice a week. It also attempt ed to show time to onset of action for both agents. A total of 54 pati ents (40 men and 14 women) were randomized to receive either MFS or KS for 4 consecutive weeks. Erythema and scaling were graded according t o a four-point scale (0 = none, 1 = slight, 2 = moderate, and 3 = seve re) at study entry and at follow-up visits at 2 and 4 weeks. Patients recorded symptom scores daily in a diary. Pruritus, if present, was ra ted on the same scale; however, it was not required for enrollment. In vestigators used the same scale to rate symptoms at baseline and at fo llow-up visits at 2 and 4 weeks. These scores were compared with the p atients' scores. In addition, patients and investigators rated efficac y according to the following scale: 1 = cleared, 2 = marked improvemen t (75% to 100% clearance), 3 = moderate improvement (50% to 75% improv ement), 4 = slight improvement (<50% clearance), 5 = no change, and 6 = exacerbation. A total of 37 patients (22 MFS, 15 KS) were cleared or markedly improved during the study. The results show that 10 patients (8 MFS, 2 KS) were cleared after 2 weeks and 22 patients (15 MFS, 7 K S) were cleared after 4 weeks of treatment. There were 7 cleared patie nts treated with MFS and 1 cleared patient treated with KS who discont inued treatment at day 14 due to 100% reduction of symptoms. No advers e events were observed among patients treated with MFS; 1 patient in t he KS group experienced mild itching on day 10, and therapy was withdr awn. According to patients' ratings in diary cards and investigators' judgments, the results of our study indicate a more rapid onset of act ion in the treatment of seborrheic dermatitis when MFS is used compare d with KS.