Brief Methodology:
It is an open label, single arm, prospective clinical study
to evaluate efficacy and safety of Hair Oil formulation in mild to moderate
Hair loss in females. The study will be conducted at one site in India. Subjects will be
advised to apply 5 to 10 ml hair oil daily on the scalp with fingertips before going to bed at
night or before bath for 60 days. The Primary objectives of study will be
assessment of hair fall by running finger test and assessment of hair breakage
by comb test over a period of 60 days. The Secondary objectives of study will
be assessments of hair fall by Hair Pull test, assessment of hair growth by
comparing against standard nonusers, assessment of effect of hair oil on
dandruff in females by standard dandruff evaluation strip, assessment of effect
of hair oil on quality of hair based on subject questionnaire, global assessment
for overall change in hair loss by the physician and subject, and assessment of
safety by observing episodes, severity and duration of any allergic reactions
and adverse events. Results:
A). Primary Objectives:
1)
Assessment of hair fall reduction by running finger test over a period
of 2 months:
There
is a significant reduction in hair fall as analyzed by Running Finger test from
baseline to 15 days, which continued till the end of the study. The average
hair fall at the baseline visit was 79.35 ±28.54, which significantly reduced
to 53.60 ±32.05 at the end of 15 days. At the end of 30 days the hair fall further
reduced to 41.42 ±27.19 while at the end of 45 days it was observed to be 37.36
±25.94. At the end of 60 days the average hair fall was seen to be 34.36 ±32.72,
which was significant as compared to its baseline reading. It was also observed
that there was a 47.8% reduction in hair fall at the end of one month while at
the end of 60 days the average hair fall reduced by 56.69%.
2)
Assessment of hair breakage by comb test over a period of 2
months:
The average no of hair as per comb test were 16.04 ±13.16 at
the baseline visit. This reduced to 11.04 ±9.55 and 9.36 ±10.18 at the end of
15 days and 30 days respectively, which was found to be statistically
significant. At the end of 45 days and 60 days the counts were 8.13 ±9.71 and 8.55
±8.94 respectively. These reductions were found to be significant as compared
to the baseline. There was a 41.64% reduction in hair count by comb test at the
end of 30 days, which further improved to 46.7% at the end of 60 days.
B). Secondary Outcome: 1). Assessment of
hair fall by Hair Pull test over a
period of 2 months
The average no of hair fall as per pull test were 1.64 ±1.68 at the baseline visit. This reduced to 1.04 ±1.20 and 0.76 ±1.09
at the end of 15 days and 30 days respectively, which was found to be
statistically significant. At the end of 45 days and 60 days the counts were 0.82
±1.33 and 0.78 ±1.49 respectively. These reductions were found to be
significant as compared to the baseline. There was a 53.85% reduction in hair fall
by pull test at the end of 30 days which further improved to 52.75% at the end
of 60 days. 2). Assessment of effect of EM/HO-01 hair oils on dandruff in
females by standard dandruff evaluation strip.
The
Dandruff score was 1.75 ±1.27 at the baseline visit. This
reduced to 1.38 ±1.16 and 1.47 ±1.39 at the end of day 15 and day 30 respectively which was
found to be statistically significant. This continued further at 45 days and 60
days where the score were 1.31 ±1.44 and 0.95 ±1.10 respectively. These
reductions were found to be statistically significant. The percentage reduction
in Dandruff score was found to
be 20.83 % at the end of 15 days, 15.62% at day 30, 25 % at day 45 and 45.83 %
at day 60 as compared to the baseline. 3). Assessment of effect on quality of hair based on subject
questionnaire. a)
a). Assessment of
effect on Visibility of scalp, Smoothness of Hair, Thickness of Hair.
The visibility of scalp as evaluated on VAS. It is observed
that at day 30, subjects had an average score of 0.94 ±1.06 (improvement), while
the end of 60 days the score was 1.70 ±1.10. This change was found to be
statistically significant between these two visits.
Smoothness was evaluated on VAS scale by the subject on Day
30 and day 60. It is observed that the average smoothness was found to be 2.14
±0.64, while it was 2.78 ±1.06 at the end of 60 days. The difference between
day 30 and day 60 was found to be statistically significant.
Thickness
of hair was evaluated on VAS scale by the subject on Day 30 and day 60. It was
observed that the average thickness was found to be 1.62 ±0.85 in EM/HO-01
group. Thickness showed a further increase of average to 2.30 ±1.13 at the end
of day 60. b). Assessment of effect on hair growth
It is observed that 6% of subjects showed mild worsening of
their condition of hair fall at Day 30. On day 60 this percentage was observed
as 8%. It was also observed that 24% had no change at day 30 and 6% were
recorded to have no change on day 60. 72% and 86% of subjects reported of
Slight to moderate improvement in their condition at Day 30 and Day 60
respectively. c). Assessment of effect on appearance of hair: It is observed that 6% of subjects showed mild worsening of
their condition of hair fall at Day 30. On day 60 this percentage was observed
as 8%. Of these 24% had no change at day 30 and 6% were recorded to have no
change on day 60. It was observed that 72% and 86% of subjects reported of
Slight to Moderate improvement in their condition at Day 30 and Day 60
respectively. d)
Assessment of effect in
slowing down hair loss:
It is observed that 6% of subjects showed either severe or
moderate or mild worsening of their condition of hair fall at Day 30. On day 60
this percentage was observed as 8%. In the study it was observed that 30% had
no change at day 30 and 20% were recorded to have no change on day 60. 64% and 72%
of subjects reported of Slight to Marked improvement in their condition at Day
30 and Day 60 respectively.
e)
Assessment of effect on greying of hair:
It is observed that all the subjects showed no change in
their greying of hair at day 30 while at day 60, 98% of the subjects showed no
change while 2% subjects showed slight improvement. 4) Global
assessment of Overall Change in hair loss by the Physician:
Physicians Global improvement scale (CGI-I) showed that 82%
of the subjects were very much improved, much improved or minimally improved. 10%
of subjects did not have any change while 8% subjects were minimally to much
worse. 5) Global assessment
of Overall Change in hair loss by Subject:
Subject’s Global improvement scale (CGI-I) showed that 82%
of the subjects were very much improved, much improved or minimally improved.
10% of subjects did not have any change while 8% subjects were minimally to
much worse. 6) Assessment of
Overall Safety as per the Physician:
It is observed that 90% of the subjects had excellent
overall safety while 10% had good overall safety. Assessment of adverse events
showed apart from a few subjects complaining of itching in the scalp none of
the adverse events were related to the study product. Assessment of vitals like
pulse, temperature and respiratory rate also observed that there were no
significant changes on these parameters over the period of 60 days of study in
both the groups. 7) Assessment of safety by observing episodes, severity and
duration of any allergic reactions & adverse events:
There were total few adverse events (AEs) such as cough,
facial palsy, nausea, insomnia, burning throat, loose motion, vomiting and
hyperacidity during the trial. Among this no AEs were related to the study Product. Conclusion: It
can be concluded from the study that there was a significant reduction in hair
fall as assessed by running finger test. Assessment by comb test for hair
breakage observed that there was a significant reduction at the end of 60 days
of study. Assessment on
other parameters also showed significant improvement in the quality of hair,
dandruff etc. Assessment of safety showed that all the subjects
showed excellent to good safety with only a few subjects having mild episodes
of itching of the scalp.
|