摘要
This 12-month, double-blind, randomized study evaluated the safety and efficacy of topical minoxidil in the treatment of male pattern baldness. Three formulations were compared: 2% minoxidil solution, 3% minoxidil solution, and placebo. After 4 months all placebo patients crossed over to treatment with the 3% solution. Of the 96 patients randomized into the study, 79 were evaluable at month 12; 25 of these were in the 2% minoxidil group, 24 were in the 3% minoxidil group, and 29 were in the placebo-to-3% solution switchover group. At monthly intervals a hair count was obtained within a 1-inch diameter area on the scalp vertex. In addition, a gross visual estimate of the degree of new hair growth over the entire balding area was made independently by the investigator and the patient. At the end of 4 months there was significant regrowth of nonvellus (terminal and indeterminate) hairs in the patients using the 2% and 3% solutions (p = 0.0001). The mean nonvellus hair count at month 4 was 162.8 in the 2% minoxidil group, 155.4 in the 3% minoxidil group, and 107.1 in the placebo group. The mean increase in the 2% and 3% treatment groups was 58.2 and 48.8, respectively, whereas the mean increase in the placebo group was 4.0. Total hair counts at month 4 demonstrated significantly more growth of hair in the 2% minoxidil group than in the placebo group (p = 0.013), with no significant difference between the 3% minoxidil group and the other two treatment groups. All three groups treated with active medication showed significant increases in total hair count at month 12 (p < 0.001). The investigators' visual assessment of growth at month 4 showed nonvellus growth in 62% of the 2% minoxidil group, 60% of the 3% minoxidil group, and 16% of the placebo group. At month 12, 91% of all patients treated with active medication exhibited some growth, with moderate or dense growth in 58% of subjects in the 2% treatment group, 64% in the 3% group, and 48% in the placebo-to-3% minoxidil crossover group. Patients' estimates of hair growth were similar to those of the investigators. No serious adverse reactions were related to the drug. Nineteen patients complained at some time of mild to moderate itching, although no patients dropped out of the study during the 12 months because of contact dermatitis. Topical minoxidil appears to be safe and effective in the treatment of male pattern baldness. This 12-month, double-blind, randomized study evaluated the safety and efficacy of topical minoxidil in the treatment of male pattern baldness. Three formulations were compared: 2% minoxidil solution, 3% minoxidil solution, and placebo. After 4 months all placebo patients crossed over to treatment with the 3% solution. Of the 96 patients randomized into the study, 79 were evaluable at month 12; 25 of these were in the 2% minoxidil group, 24 were in the 3% minoxidil group, and 29 were in the placebo-to-3% solution switchover group. At monthly intervals a hair count was obtained within a 1-inch diameter area on the scalp vertex. In addition, a gross visual estimate of the degree of new hair growth over the entire balding area was made independently by the investigator and the patient. At the end of 4 months there was significant regrowth of nonvellus (terminal and indeterminate) hairs in the patients using the 2% and 3% solutions (p = 0.0001). The mean nonvellus hair count at month 4 was 162.8 in the 2% minoxidil group, 155.4 in the 3% minoxidil group, and 107.1 in the placebo group. The mean increase in the 2% and 3% treatment groups was 58.2 and 48.8, respectively, whereas the mean increase in the placebo group was 4.0. Total hair counts at month 4 demonstrated significantly more growth of hair in the 2% minoxidil group than in the placebo group (p = 0.013), with no significant difference between the 3% minoxidil group and the other two treatment groups. All three groups treated with active medication showed significant increases in total hair count at month 12 (p < 0.001). The investigators' visual assessment of growth at month 4 showed nonvellus growth in 62% of the 2% minoxidil group, 60% of the 3% minoxidil group, and 16% of the placebo group. At month 12, 91% of all patients treated with active medication exhibited some growth, with moderate or dense growth in 58% of subjects in the 2% treatment group, 64% in the 3% group, and 48% in the placebo-to-3% minoxidil crossover group. Patients' estimates of hair growth were similar to those of the investigators. No serious adverse reactions were related to the drug. Nineteen patients complained at some time of mild to moderate itching, although no patients dropped out of the study during the 12 months because of contact dermatitis. Topical minoxidil appears to be safe and effective in the treatment of male pattern baldness.