was performed to test if the proportion of the combined agree responses was equal to the combined disagree responses for each applicable question.
Subject satisfaction questionnaires were completed at weeks 4, 6, and 12 using a 5-point Likert response scale (1 = Strongly Agree to 5 = Strongly Disagree) to rate satisfaction
with improvement in hair volume, texture, and quality as well as with the use of the regimen. Frequency and percentage
of all response options were recorded and pooled as “Agree†(combining “Strongly Agree†and “Agreeâ€), “Neutral†(“Neither Agree nor Disagreeâ€), and “Disagree†(combining “Strongly Disagree†and “Disagreeâ€). A binomial (sign) test was performed to test if the proportion of the combined agree responses was equal to the combined disagree responses for each applicable question. All statistical tests were 2-sided at significance level α = 0.05.
RESULTS
A total of 56 male subjects between the ages of 22 and 60 with type III and IV Norwood hair loss pattern were included in the
intent-to-treat (ITT) study population (Table 1). The mean age was 45.5 years, 60.7% of the subjects were Caucasian, 19.6% were Hispanic or Latino, and 8.9% were Black or African American. Investigator
assessment ratings of subject photographs showed that the twice-daily regimen of minoxidil 5% foam in combination
with BHS significantly improved scalp hair coverage and demonstrated overall treatment benefit at weeks 4, 6, and 12, relative
to baseline (P<.001) (Figure 1). Representative photographs are shown in Figure 2. In addition, investigator ratings indicated significant improvement in hair growth (33.9% Agree vs 0% Disagree)
(P<.001) at week 4, and hair thinning (50.0% Agree vs 1.8% Disagree) (P<.001) at week 6 (data not shown).
Subject self-assessment ratings indicated that a significant proportion of subjects agreed with improvement in the appearance
of their hair and satisfaction with overall improvement at weeks 6 and 12, relative to baseline (P<.05) (Figure 3). In addition, subjects significantly agreed that they were satisfied with their hair growth (71.4% Agree vs 8.9% Disagree) and the hair on the top of their head (64.3% Agree vs 12.5% Disagree) (P<.001) as early as week 6 (data not shown).
