Propecia Clinical Trials and Studies

The efficacy of active ingredient of Propecia, Finasteride was demonstrated in men (88% Caucasian) with mild to moderate androgenetic alopecia (male pattern hair loss) between 18 and 41 years of age. In order to prevent seborrheic dermatitis which might confound the assessment of hair growth in these studies (controlled phase and extensions), all men, whether treated with finasteride or placebo, were instructed to use a specified, medicated, tar-based shampoo (Neutrogena T/Gel Shampoo).

There were three double-blind, randomized, placebo-controlled studies of 12-month duration. The two primary endpoints were hair count and patient self-assessment; the two secondary endpoints were investigator assessment and ratings of photographs. The three studies were conducted in 1,879 men with mild to moderate, but not complete, hair loss. Two of the studies enrolled men with predominantly mild to moderate vertex hair loss (n=1,553). The third enrolled men having mild to moderate hair loss in the anterior mid-scalp area with or without vertex balding (n=326).

Two Propecia studies on Vertex Baldness

Of the men who completed the first 12 months of the two vertex baldness trials, 1,215 elected to continue in double-blind, placebo-controlled, 12-month extension studies. There were 547 men receiving finasteride for both the initial and extension periods (up to 24 months) and 60 men receiving placebo for the same periods. In addition, there were 65 men who received finasteride for the initial 12 months followed by placebo in the 12-month extension period, and 543 men who received placebo for the initial 12 months followed by finasteride in the 12-month extension period (See Figure below).

Hair counts were assessed by photographic enlargements of a representative area of active hair loss. In these two studies in men with vertex baldness, significant increases in hair count were demonstrated at 6 and 12 months in men treated with finasteride, while significant hair loss from baseline was demonstrated in those treated with placebo. At 12 months there was a 107-hair difference from placebo (p<0.001, finasteride [n=679 evaluable men] vs placebo [n=672 evaluable men]) within a 1-inch diameter circle (5.1 cm2). Hair count was maintained in those men taking finasteride (n=433 evaluable men) for up to 24 months, while the placebo group (n=47 evaluable men) continued to show progressive hair loss. At 24 months, this resulted in a 138-hair difference between treatment groups (p<0.001) within the same area. Patients who switched from placebo to finasteride (n=426 evaluable men) at the end of the initial 12 months had an increase in hair count at 24 months. A change of treatment from finasteride to placebo (n=48 evaluable men) at the end of the initial 12 months resulted in reversal of the increase in hair count 12 months later, at 24 months. See figure below for combined study results.

Effect on Hair Count† Number of Hairs in a 1-Inch Diameter Circle Mean Change + 1 S.E.

† Pooled data from vertex hair loss studies (mean baseline hair count = 876) †† At the end of initial 12-month period treatment switched from finasteride to placebo (- - - - finasteride/ Placebo) or from placebo to finasteride (------------ Placebo/finasteride)

At 12 months, 14% of men treated with finasteride had hair loss (defined as any decrease in hair count from baseline) compared with 58% of men in the placebo group. In men treated for up to 24 months, 17% of those treated with finasteride demonstrated hair loss compared with 72% of those in the placebo group.

Patient self-assessment was obtained at each clinic visit from a self-administered questionnaire, which included questions on their perception of hair growth, hair loss, and appearance. This self-assessment demonstrated an increase in amount of hair, a decrease in hair loss, and improvement in appearance in men treated with finasteride. Overall improvement compared with placebo was seen as early as 3 months (p<0.05), with continued improvement over 24 months.

Investigator assessment was based on a 7-point scale evaluating increases or decreases in scalp hair at each patient visit. This assessment showed significantly greater increases in hair growth in men treated with finasteride compared with placebo as early as 3 months (p<0.001). At 12 months, the investigators rated 65% of men treated with finasteride as having increased hair growth compared with 37% in the placebo group. At 24 months, the investigators rated 80% of men treated with finasteride as having increased hair growth compared with 47% of men treated with placebo.

Standardized photographs of the head were assessed in a blinded fashion, at the beginning of the study and at 6, 12, 18 and 24 months. An independent panel rated increases or decreases in scalp hair on the same 7-point scale as the investigator assessment. At 12 months, 48% of men treated with finasteride had an increase as compared with 7% of men treated with placebo. At 24 months, an increase in hair growth was demonstrated in 66% of men treated with finasteride compared with 7% of men treated with placebo. Based on this assessment, continued treatment with finasteride resulted in further improvement. These results were observed in the context of no further increase in hair count between month 12 and month 24.

In one of the two vertex baldness studies, patients were questioned on non-scalp body hair growth. Finasteride did not appear to affect non-scalp body hair.

Summary of Propecia Clinical Trials and Studies

Clinical studies were conducted in men aged 18 to 41 with mild to moderate degrees of androgenetic alopecia. All men treated with finasteride or placebo received a tar-based shampoo (Neutrogena T/Gel®** Shampoo). Clinical improvement was seen as early as 3 months in the patients treated with finasteride and led to a net increase in scalp hair count and hair regrowth. In addition, clinical studies demonstrated slowing of hair loss with finasteride by patient self-assessment. These effects were maintained through the second year of treatment. Maintenance of or improvement in clinical efficacy has also been demonstrated in controlled and open-extension studies for up to 3 years.

Ethnic Analysis of Propecia Clinical Data

In a combined analysis of the two studies on vertex baldness, mean hair count changes from baseline were 91 vs –19 hairs (finasteride vs placebo) among Caucasians (n=1,185), 49 vs –27 hairs among Blacks (n=84), 53 vs –38 hairs among Asians (n=17), 67 vs 5 hairs among Hispanics (n=45) and 67 vs -15 hairs among other ethnic groups (n=20). Patient self-assessment showed improvement across racial groups with finasteride treatment, except for satisfaction of the frontal hairline and vertex in Black men, who were satisfied overall.

A sexual function questionnaire was self-administered by patients participating in the two vertex baldness trials to detect more subtle changes in sexual function. At Month 12, statistically significant differences in favor of placebo were found in 3 of 4 domains (sexual interest, erections, and perception of sexual problems). However, no significant difference was seen in the question on overall satisfaction with sex life.