Abstract:
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Patients and methods
The study group comprised 52 otherwise healthy subjects with androgenic alopecia (28 males and 24 females; aged 18 to 38 years, mean 28; Table I). No patient had received therapy for alopecia or other cutaneous or noncutaneous diseases for at least 1 month prior to beginning the protocol. Moreover, no female patient had been taking oral contraceptives during the previous year. After informed consent had been obtained, patients were randomly allocated into two study groups: 26 patients received a 0.005% solution of finasteride; the remainder received the vehicle only (consisting of 50% ethyl alcohol, 25%
propylene glycol, and 25% distilled water). The identity of the treatment was concealed from the patients, according
to a single-blind study design. The trial was conducted over a 16-month period during which each patient applied 1.0 ml of the study medication using a graduated dropper twice daily to the balding area(s) of the scalp. All patients were examined at monthly intervals. At each visit, photographs were taken. During treatment the clinical response was followed by comparing sequential photo- graphs.
At the end of the study, the assessment of the results in terms of hair regrowth was made by the same staff member according to the six-point scale shown in Table 11.
The results were also evaluated in terms of hair loss by performing a 'wash test' at 2-month intervals. The wash test was carried out according to the following standardized procedure: patients were asked not to wash their scalp for 1 week, during which they had to comb their hair twice a day (morning and evening). They were instructed to collect all hairs lost during shampooing at the end of this period (this was accomplished by placing a small-mesh net over the drain of the bathtub at home). The bimonthly hair counts of all patients were then recorded and the unpaired Student's t-test was used to evaluate the significance of differences observed between the two study groups throughout the treatment course. Furthermore, at the end of treatment the patients' opinions and self-perceived changes in the status of the scalp hair were recorded and categorized according to a four-point scale of effectiveness with 3 indicating high effectiveness and 0 indicating no effect.
Prior to treatment and every 3 months, the following laboratory tests were carried out: complete blood cell count; full serum and urine chemistry panel; and determination of plasma concentration of total testosterone, free testosterone and dihydrotestosterone. The latter investigations were performed only in the group receiving finasteride, in order to detect any possible systemic effect related to percuta- neous absorption of finasteride. In females, blood samples were taken on day 21 of the menstrual cycle.
ResuIt s
Of the 52 patients enrolled, 36 (69.2%) completed the entire study period. Notably, all dropouts occurred in the placebo group after 1 to 10 months. Moreover, the overall tolerability of the treatment was excellent. No patient experienced any local or systemic untoward effect. In particular, in the finasteride group laboratory data revealed no relevant change in plasma levels of total testosterone, free testosterone or dihydrotestosterone. On the basis of these findings any significant percutaneous absorption of the drug could reasonably be excluded.
Evaluation of hair regrowth
During the first 3 months of the trial, the clinical response was not significant. The scores for hair regrowth ranged from 1 to 2 with no significant difference between the two study groups. By contrast, throughout the subsequent course of the study a significant improvement in the status of the scalp hair was observed among the finasteride- treated patients. At the end of the study, the clinical results were scored 4 in 12 patients and 3 in the remaining 14. Response to treatment was substantiated by both an increase in the hair density at the periphery of balding areas and a progressive, though slow and incomplete retrieval of the hair texture within previously bare sites. Patients initially grew vellus-type hair that tended to
change to thicker, pigmented terminal hair as the clinical response progressed. As for the group receiving placebo, only ten patients were evaluable at the end of the study. The high number of dropouts was a result of the lack of any improvement in the status of the scalp hair. These results were scored as follows: 2 in three patients, 1 in three patients and 0 in four patients.
Evaluation of hair loss
As shown in Table 111 and Figure 1, differences between the two study groups in terms of hair counts after the wash test were not significant at baseline or during the first 4 months of treatment. However, beginning from the Gth month, a progressive decrease in the rate of hair loss was observed in the finasteride group. Differences between the groups showed a gradually higher level of significance (P>O.l to
<0.0001).
Patients' opinion on the effectiveness of treatment
Among the finasteride group the overall judgement of cosmetic improvement was positive. Effectiveness was scored 3 by 19 patients (73%) and 2 by the remaining 7. By contrast, among the placebo group the results in the 16 patients who completed the study were scored as follows: 2 in one patient, 1 in three patients and 0 in six patients.