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CLINICAL TRIAL REPORT
Oral and Topical Administration of a Standardized
Saw Palmetto Oil Reduces Hair Fall and Improves the
Hair Growth in Androgenetic Alopecia Subjects –
A 16-Week Randomized, Placebo-Controlled Study
Heggar Venkataramana Sudeep
1
, Sriram Rashmi
2
, Thomas V Jestin
3
, Aleksander Richards
4
,
Kuluvar Gouthamchandra
1
, Kodimule Shyamprasad
1
1
Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd, Bangalore, Karnataka, India;
2
BGS Global Institute of
Medical Sciences, Bangalore, Karnataka, India;
3
Department of Clinical Research, Leads Clinical Research and Bio Services Private Ltd, Bangalore,
Karnataka, India;
4
Department of Clinical Studies, R&D, Vidya Herbs, Red Bank New Jersey USA
Correspondence: Heggar Venkataramana Sudeep, Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd, Bangalore,
Karnataka, India, Email research@vidyaherbs.com; sudeepkashyap.82@gmail.com
Purpose: Androgenetic alopecia (AGA) is the most common type of hair loss in humans, affecting self-esteem and emotional well-
being. This study aimed to assess the safety and efcacy of VISPO
TM
, a standardized saw palmetto oil (2–3% β-sitosterol), in subjects
with mild-to-moderate AGA.
Methods: In a double-blind, placebo-controlled, four-arm clinical study, 80 healthy male and female subjects aged 18–50 years were
randomly allocated (1:1:1:1) to receive either 400 mg capsules of VISPO or 5 mL of a topical formulation containing 20% VISPO or
the respective placebo once daily for 16 weeks. The primary endpoints included hair count (hair comb and hair pull tests) and the self-
assessment of perceived efcacy. Objective evaluation was performed using the global photographic assessment score. Hair density,
thickness, and anagen/telogen ratio were evaluated using phototrichogram analysis.
Results: At the end of the study, oral and topical formulations of VISPO reduced hair fall by up to 29% (p<0.001) and 22.19%
(p<0.01) from the baseline, respectively. Hair density increased by 5.17% and 7.61% in the oral and topical VISPO groups,
respectively (p<0.001). In addition, oral ingestion of VISPO resulted in a marked reduction in serum dihydrotestosterone (DHT)
levels in the subjects compared to placebo (p<0.001). However, the effect of the VISPO formulations on the anagen/telogen ratio was
insignicant. No serious adverse effects were observed during the study.
Conclusion: VISPO formulations reduced hair fall and promoted hair regrowth and scalp appearance in AGA patients.
Keywords: hair loss, androgenetic alopecia, saw palmetto, β-sitosterol, fatty acids
Introduction
Androgenetic alopecia (AGA) is a progressive hair loss condition, with a characteristic pattern in both men and women.
In men, AGA, also known as male pattern hair loss (MPHL), is caused by a greater sensitivity of the hair follicles to the
androgens;
1
however, the cause of female pattern hair loss (FPHL) and its association with androgen remain unclear.
2
The incidence of progressive hair loss by AGA has become more prevalent in recent years. AGA is common in nearly
80% of aging men.
3
Hair loss negatively impacts the psychological and social well-being of an individual.
4
Presently,
minoxidil and nasteride are the only FDA (Food and Drug Administration) approved medications for AGA. Minoxidil
is used for topical applications and works by stimulating hair follicles via anagen phase induction. Several clinical studies
have reported the efcacy of minoxidil against alopecia, including AGA, Alopecia areata, and scarring alopecia.
5–7
Minoxidil is associated with non-serious side effects such as scalp irritation, facial hypertrichosis, and allergic contact
dermatitis.
8
Finasteride, another well-known medication for AGA, functions by inhibiting the conversion of testosterone
Clinical, Cosmetic and Investigational Dermatology 2023:16 3251–3266 3251
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Clinical, Cosmetic and Investigational Dermatology Dovepress
open access to scientific and medical research
Open Access Full Text Article
Received: 16 August 2023
Accepted: 24 October 2023
Published: 11 November 2023
to dihydrotestosterone (DHT) via regulation of 5α-reductase enzyme activity.
9
Despite its efcacy against hair loss, the
associated side effects cannot be ignored. Long-term treatment with nasteride has been reported to have sexual side
effects such as erectile dysfunction and decreased libido.
10
Serenoa repens (Fam.) Arecaceae) dwarf trees, commonly known as saw palmetto (SP), grown largely in parts of
North America. Saw palmetto oil extracted from plant berries contains 85–90% fatty acids and other constituents such as
β-sitosterol, capric acid, caprylic acid, and caproic acid.
11,12
SP competitively inhibits 5α-reductase activity and restricts
the conversion of testosterone to DHT.
13
Due to its anti-androgenic properties SP has gained potential as a dietary
supplement and medication for conditions such as benign prostate hyperplasia and hair loss.
14
Previously, SP in food
supplements has been clinically evaluated for the prevention of hair loss in AGA subjects.
15–17
However, most clinical
studies have been conducted on formulations of SP with vitamins and minerals, making it difcult to understand the
magnitude of efcacy of SP alone. Hence, it is important to study the hair care potential of SP individually, using
randomized clinical trials.
VISPO
TM
is a proprietary extract containing standardized β-sitosterol and total fatty acid contents. Previously, the
efcacy of VISPO was studied in a preclinical model of benign prostate hyperplasia (BPH).
18
Further in a comparative
clinical study with conventional SP extract, the efcacy and safety of VISPO were conrmed in BPH subjects.
19
Here,
the protective effect of VISPO as an oral and topical supplement against hair fall was observed in subjects with AGA.
Materials and Methods
VISPO
TM
The investigational product VISPO
TM
used in this study was manufactured by Vidya Herbs Pvt. Ltd. (Bangalore, India)
via supercritical uid extraction. VISPO is a standardized saw palmetto extract containing 2–3% β-sitosterol and ≥ 85%
total fatty acids. The extract was formulated for ingestion and topical application. Each 400 mg capsule contained
100 mg of VISPO. The placebo capsules contained maltodextrin and had a similar appearance and color to VISPO
capsules. VISPO was formulated into a lotion form for topical application, such that each 100 g lotion contained 20
g VISPO. The composition details of the oral and topical formulations are provided in Supplementary Table 1 and 2.
Study Design
This 16-week double-blind, randomized, placebo-controlled, parallel-group, single-center, four-arm study was conducted
on an Indian population at the BGS Global Institute of Medical Sciences, Bengaluru, Karnataka, India. The study
Protocol No (Protocol no. LCBS-VH-95) was approved by the Institutional Ethics Committee (IEC) (Reg. No. ECR/
1307/Inst/KA/2019), on 11th October 11, 2022. The trial was prospectively registered in the Clinical Trial Registry, India
(CTRI/2022/10/046767), on October 25, 2022. This study was performed in accordance with the Declaration of Helsinki
and Good Clinical Practice (GCP) guidelines.
Sample Size Calculation
A sample size of 80 subjects (20 in each group) was required to establish a power of 80% and 5% level of signicance.
This sample size was sufcient to demonstrate a clinically meaningful difference between the VISPO and placebo groups
in terms of reduction in hair fall from baseline to week 16 (Supplementary Material).
Study Participants
Healthy adult male and female subjects aged 18–50 years with mild-to-moderate AGA were enrolled in this study.
Subject inclusion was based on the Norwood Hamilton scale (grade II to grade VA with vertex involvement) in males
and the Sinclair scale (Grade II to IV) in females. The exclusion criteria were as follows: (a) conditions such as
alopecia areata, alopecia totalis, alopecia universalis, and alopecia diffusa; (b) scarring of the scalp or any other
condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue the use of hair
weaving; (c) history of chronic health conditions (eg, diabetes, hypertension, chronic renal failure, heart and liver
disease), endocrine abnormalities including stable thyroid disease, psychiatric illness, drug abuse, smoking, addiction
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to alcohol, bariatric surgery/eating disorders such as bulimia or binge eating, cardiovascular surgery, or history of any
other major surgery; (d) use of medications such as minoxidil, drugs with anti-androgenic properties (for example,
cyproterone acetate, spironolactone, ketoconazole, utamide, bicalutamide), drugs potentially causing hypertrichosis
(eg, cyclosporine, diazoxide, phenytoin psoralens), Anabolic steroids, Lithium and phenothiazines during six months
prior to screening; use of systemic steroids for more than 14 days within the past 2 months prior to enrolment in the
study; use of isotretinoin, light therapy, radiation to the scalp, or chemotherapy within the past year; (e) subjects
allergic to herbal products; (f) subjects with any clinically signicant systemic or cutaneous disease, which may
interfere with study treatments or procedures. All enrolled subjects signed an IEC-approved informed consent form
before participation.
Randomization and Blinding
After baseline measurements, the subjects were randomly assigned to one of the following four groups through block
randomization: the VISPO oral intervention group (n=20), placebo oral group (n=20), VISPO topical intervention group
(n=20), and placebo topical group (n=20). Each participant received an IP bottle with unique code. The code for each
group and patient in the study was generated by a statistician using the R statistical software (version 4.2.1).
Randomization numbers and respective IP codes were provided to the investigators. The investigators and study
personnel responsible for enrolling the participants and conducting the trial were blinded to the randomization process
throughout the study. The test product and placebo were identical in their external form.
Outcomes
This clinical study was performed to evaluate the effectiveness and safety of VISPO against hair falls in male and female
patients with AGA. The primary objective was to assess hair fall during the study using dermatological examination (hair
comb and hair pull tests) and subject self-assessment. The secondary efcacy objectives included (a) assessment of hair
density, thickness, and anagen/telogen ratio as measured using phototrichogram and investigator assessment scoring
(photograph scoring) and (b) changes in serum biomarkers 5α-reductase and DHT.
Procedures
In this double-blind parallel-group study, 80 healthy adult subjects meeting all the inclusion criteria and no exclusion
criteria were randomly assigned to one of the four treatment arms in a 1:1:1:1 ratio. Active treatments included VISPO
100 mg in 400 mg capsules and 20% in lotion form as oral and topical formulations, respectively. The other two groups
were the placebo groups for oral and topical treatments. The subjects in the oral treatment group self-administered
400 mg capsules once daily (after dinner) for 16 weeks. For topical application, approximately 5 mL of hair lotion (one
press) was applied once a day on the scalp, followed by a hair wash 30 min after application. Instructions for the product
application and hair care to be followed and a subject diary to record the study IP administration, side effects,
concomitant medication, changes in scalp condition, and medical condition details during the entire study period were
provided.
The dermatological assessment of hair fall reduction included hair comb and hair pull tests, as described
elsewhere.
20,21
Self-assessment of hair growth and appearance was based on validated questionnaires: the Hair
Growth Index (HGI) (3-questioned 7-point scale) and Hair Growth Satisfaction Scale (HGSS) (5-questioned 7-point
scale).
22
Global photographs of the scalp (vertex and anterior regions) were obtained at baseline, follow-up (8 weeks), and at
the end of the study (16 weeks). Photographic assessment was performed by a dermatologist blinded to the treatments
using a 7-point rating scale.
23
The hair density and thickness were measured using CASLITE Nova (Catseye Systems &
Solutions, Mumbai, Maharashtra, India).
Safety Evaluations
The cutaneous tolerability of the topical application was based on a 5-point scale of investigator assessment (erythema,
dryness, scaling, allergic reactions, and folliculitis). The self-assessment of the application site included seven
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parameters: redness, aking, itching, burning sensation, allergic reaction, eruptions, and boils. Clinical laboratory
evaluations included serum biochemical analysis of liver and renal function parameters, and hematological parameters.
The subjects were monitored for adverse events (AEs) and serious adverse events (SAEs) throughout the study.
Statistical Analysis
Comparison of baseline demographic and physical characteristics between the study groups and analyses of categorical
variables were performed using the chi-square test. All efcacy data were analyzed for normal distribution using the
Shapiro–Wilk test. Changes within the group from baseline to weeks 8 and 16 were analyzed using a paired t-test.
Comparisons between the groups were performed using an independent t-test. Skewed data were analyzed using the
Mann–Whitney test (between the groups) and Wilcoxon signed-rank test (within the group). All data were analyzed using
R statistical software (version 4.2.1).
Results
In this clinical trial, 97 human volunteers with mild-to-moderate AGA were screened. Based on the inclusion/exclusion
criteria, 80 subjects were enrolled and randomized into 4 treatment arms (n = 20 in each group). During the study, seven
subjects withdrew (were lost to follow-up); thus, 73 completed the study (November 2022 to April 2023). The subjects’
disposition during the study is shown in Figure 1. Per-protocol (PP) analysis was used to analyze study outcomes.
Subject demographics were similar across the treatment groups, and no signicant differences were observed in
categorical variables (Table 1).
Primary Outcomes
Investigator Assessment of Hair Shedding
In the present study, the protective effect of VISPO on hair shedding was validated using the hair comb and hair pull
tests. The hair comb test, also known as 60-second hair count, is a simple and reliable tool for assessing hair shedding.
20
(Wasko et al 2008). As shown in Table 2, hair shedding in the VISPO oral treatment group was reduced by 24.74% and
29% (p<0.001) after 8 and 16 weeks of treatment, respectively, compared to baseline. In the topical VISPO group, the
hair fall score reduced by 12.08% and 22.19% (p<0.05) from baseline after 8 and 16 weeks of treatment, respectively
(Table 3). In contrast, hair fall signicantly increased in the respective placebo groups from baseline to the end of the
study (p<0.05).
Figure 1 Participant ow chart.
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Table 1 Demographic Characteristics of the Subjects
Group A
(VISPO oral)
N = 18
Group B
(Placebo oral)
N = 19
Group C
(VISPO Topical)
N = 18
Group D
(Placebo Topical)
N = 18
p-value
(A vs B)
p-value
(C vs D)
Sex Male, n (%) 14 (70) 14 (70) 16 (80) 16 (80) 1.000
#
1.000
#
Female, n (%) 6 (30) 6 (30) 4 (20) 4 (20)
Age (y) 35.10±6.03 36.45±6.01 34.05±7.07 35.85±6.28 0.483
‡
0.399
‡
Height (cm) 166.40±10.19 165.55±8.12 169.05±8.11 170.60±8.71 0.708
‡
0.134
‡
Weight (kg) 67.06±9.90 68.23±9.65 68.19±10.91 73.31±10.22 0.772
‡
0.564
‡
BMI (kg/m
2
) 24.20±2.67 24.82±2.48 23.76±2.74 25.13±2.38 0.452
‡
0.101
‡
Notes: The values are presented as the mean ± standard deviation.
#
Chi-square test;
‡
Unpaired t-test.
Table 2 Effect of VISPO Oral Administration on Different Hair Parameters
VISPO (n=18) Placebo (n=19) p-value (VISPO vs Placebo)
Hair comb test score
Baseline 19.56±6.67 19.32±7.67 0.920
‡
Week 8 14.72±6.06 22.32±7.48 0.002
‡
**
Week 16 13.89±5.68 22.84±6.46 <0.001
‡
***
p-value (Baseline vs Week 8) <0.001
#
*** 0.002
#
** -
p-value (Baseline vs Week 16) <0.001
#
*** 0.030
#
* -
Hair pull test score
Baseline 8.53±0.40 8.53±0.31 0.990
‡
Week 8 7.28±0.77 8.58±0.38 <0.001
§
***
Week 16 6.78±0.65 8.66±0.37 <0.001
§
***
p-value (Baseline vs Week 8) <0.001
†
*** 0.608
†
–
p-value (Baseline vs Week 16) <0.001
†
*** 0.243
†
–
Hair density (Hairs/cm
2
)
Baseline 222.56±46.81 215.21±29.05 0.573
‡
Week 8 227.56±39.45 209.37±30.03 0.126
‡
Week 16 234.06±37.74 208.26±29.18 0.027
‡
*
p-value (Baseline vs Week 8) 0.123
#
0.112
#
–
p-value (Baseline vs Week 16) 0.009
#
** 0.033
#
* –
Hair thickness (µm)
Baseline 16.89±3.46 17.16±2.61 0.792
‡
Week 8 17.94±3.90 16.89±3.57 0.400
‡
Week 16 19.61±3.26 17.53±3.45 0.067
‡
(Continued)
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In the hair pull test, the VISPO oral treatment group showed a progressive reduction in the hair fall score from
baseline at visits 2 (8 weeks) and 3 (16 weeks). Hair fall was reduced by 14.65% and 20.52% after 8 and 16 weeks of
VISPO ingestion, respectively, compared with baseline (p<0.001) (Table 2). A similar trend was observed in the VISPO
Table 2 (Continued).
VISPO (n=18) Placebo (n=19) p-value (VISPO vs Placebo)
p-value (Baseline vs Week 8) 0.249
#
0.759
#
-
p-value (Baseline vs Week 16) 0.017
#
* 0.636
#
-
Anagen/Telogen ratio
Baseline 3.14±1.01 3.19±1.07 0.899
‡
Week 8 3.24±1.32 2.94±0.86 0.488
§
Week 16 3.65±1.23 2.97±1.20 0.112
§
p-value (Baseline vs Week 8) 0.917
†
0.193
†
-
p-value (Baseline vs Week 16) 0.139
†
0.533
†
-
Notes: Values are mean±standard deviation (SD).
#
Paired t-test;
‡
Independent t-test;
†
Wilcoxon signed-rank test;
§
Mann–Whitney U-test.
*p<0.05, **p<0.01 and ***p<0.001.
Table 3 Effect of VISPO Topical Administration on Different Hair Parameters
VISPO (n=18) Placebo (n=19) p-value (VISPO vs Placebo)
Hair comb test score
Baseline 20.28±7.32 18.94±9.93 0.650
‡
Week 8 17.83±5.59 21.28±8.32 0.007
§
**
Week 16 15.78±6.41 22.94±8.69 0.008
‡
**
p-value (Baseline vs Week 8) 0.044
†
* 0.091
†
p-value (Baseline vs Week 16) 0.029
#
* 0.018
#
*
Hair pull test score
Baseline 8.53±0.44 8.47±0.40 0.693
‡
Week 8 7.33±0.64 8.56±0.34 <0.001
§
***
Week 16 6.78±0.55 8.58±0.35 <0.001
§
***
p-value (Baseline vs Week 8) <0.001
†
*** 0.437
†
p-value (Baseline vs Week 16) <0.001
†
*** 0.362
†
Hair density (Hairs/cm
2
)
Baseline 205.67±34.34 230.22±47.15 0.084
‡
Week 8 214.11±35.48 222.94±49.96 0.545
‡
Week 16 221.33±37.61 221.83±45.90 <0.001
§
***
p-value (Baseline vs Week 8) <0.001
#
*** 0.007
#
**
p-value (Baseline vs Week 16) 0.0016
†
** 0.044
†
*
(Continued)
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topical treatment group, wherein hair fall was reduced by 14.06% and 20.52% from the baseline scores at visits 2 and 3,
respectively (p<0.001) (Table 3).
As shown in Figure 2, the reduction in hair fall in the VISPO treatment groups from baseline to the end of the study
was signicant compared with that in the respective placebo groups (p<0.001).
Subject Self-Assessment Questionnaires
The HGI is a validated, self-administered, 7-point scale hair growth questionnaire (hair thinning, coverage, and overall
appearance). In the present study, the percentage of subjects who responded positively to the improvement in hair
thickness and shaft appearance was signicantly higher in the VISPO oral group than in the placebo (p<0.05). In
addition, a considerable proportion of subjects in the VISPO oral group (33.3%) showed improvement in the amount of
hair covering the scalp. However, most subjects in the topical treatment group responded with “no change” in the HGI
questionnaire (Table 4).
Hair growth satisfaction scale (HGSS) is a validated, self-administered 7-point scale that assesses satisfaction with the
appearance of scalp hair (overall, scalp appearance, coverage, amount of hair in the thinning areas, and hair growth in the
Figure 2 Effect of VISPO formulations on the changes in hair fall (count) from baseline to the end of study. (A) Hair comb test and (B) hair pull test. The data were analyzed
by independent t-test. **p<0.01 and ***p<0.001.
Table 3 (Continued).
VISPO (n=18) Placebo (n=19) p-value (VISPO vs Placebo)
Hair thickness (µm)
Baseline 16.50±4.40 16.61±3.88 0.936
‡
Week 8 17.17±3.38 16.17±3.03 0.357
‡
Week 16 17.44±3.67 16.56±3.40 0.456
‡
p-value (Baseline vs Week 8) 0.378
#
0.606
#
p-value (Baseline vs Week 16) 0.420
#
0.945
#
Anagen/Telogen ratio
Baseline 3.10±0.95 3.25±0.89 0.631
‡
Week 8 2.96±0.81 2.97±0.76 0.936
§
Week 16 3.10±0.87 2.74±0.95 0.193
§
p-value (Baseline vs Week 8) 0.323
†
0.202
†
p-value (Baseline vs Week 16) 0.886
†
0.049
†
*
Notes: Values are mean±standard deviation (SD).
#
Paired t-test;
‡
Independent t-test;
†
Wilcoxon signed-rank test;
§
Mann–Whitney U-test.
*p<0.05, **p<0.01 and ***p<0.001.
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thinning areas). A high proportion of subjects in all treatment groups responded with “no change” to the HGSS
questionnaire at the end of the study (Table 5). However, 33.33% of the VISPO oral group subjects provided positive
feedback on “the overall appearance”, ‘the amount of hair covering the scalp”, and “new hair growth”.
Secondary Outcomes
In the present study, phototrichogram analysis was used to measure secondary parameters such as hair density, thickness,
and anagen/telogen ratio. At the end of the study, hair density in the VISPO oral group increased by 5.17% (p<0.01),
while in the respective placebo group, it was reduced by 3.23% relative to the baseline (p<0.05). Furthermore, there was
a signicant increase in the mean hair thickness in the VISPO oral group compared with the baseline measurement
(p<0.05). The anagen/telogen ratio increased in the VISPO oral group at the end of the study. However, these differences
were not statistically signicant (Table 2). The VISPO topical group showed a signicant increase in hair density after 8
(4.1%, p<0.001) and 16 weeks (7.61%, p<0.001) of treatment compared to the baseline. However, in comparison with the
baseline data, there was an insignicant change in hair thickness and anagen/telogen ratio in the VISPO topical group
(Table 3). The change in hair density from baseline to the end of the study was signicant in the VISPO oral and topical
treatment groups compared with the respective placebo groups (p<0.001), whereas the changes with respect to hair
thickness and anagen/telogen ratio were not statistically signicant (Figure 3).
The global photographic assessment of scalp hair is presented in Table 6. The proportion of subjects showing
improvement in both vertex and anterior scalp views at the end of the study was higher in the VISPO oral group than in
the placebo group. In contrast, most participants in the VISPO topical treatment group showed no change in the
photograph score. However, the proportion of subjects with a minimal decrease in the assessment score was lower in
the topical VISPO group than in the placebo group. Figure 4 shows representative images of the photographic assessment
and phototrichogram analysis.
In the present study, serum samples from the subjects at baseline and at the end of the study were quantied for 5α-
reductase levels using ELISA. As shown in Figure 5A, the VISPO oral and topical groups showed no signicant change
in the enzyme level from baseline to the end of the study compared to the respective placebo groups. Interestingly, the
Table 4 Subject Self-Assessment – Hair Growth Index (HGI) Scoring
Group A
VISPO – Oral
N = 18 n (%)
Group B
Placebo – Oral
N = 19 n (%)
Group C
VISPO – Topical
N = 18 n (%)
Group D
Placebo – Topical
N = 18 n (%)
p-value
(A vs B)
p-value
(C vs D)
The area of thinning hair
Decreased 0 (0) 1 (5.26) 0 (0) 1 (5.56) 0.170
‡
0.597
‡
Increased 6 (33.33) 2 (10.53) 2 (11.11) 2 (11.11)
No change 12 (66.67) 16 (84.21) 16 (88.89) 15 (83.33)
The amount of hair covering the scalp
Decreased 0 (0) 0 (0) 1 (5.56) 1 (5.56) 0.092
‡
0.833
‡
Increased 6 (33.33) 2 (10.53) 1 (5.56) 2 (11.11)
No change 12 (66.67) 17 (89.47) 16 (88.89) 15 (83.33)
The quality of existing hair in terms of thickness and hair shaft appearance
Decreased 0 (0) 1 (5.26) 1 (5.56) 1 (5.56) 0.022
‡
* 0.833
‡
Increased 9 (50) 2 (10.53) 1 (5.56) 2 (11.11)
No change 9 (50) 16 (84.21) 16 (88.89) 15 (83.33)
Note:
‡
Chi square test; *p<0.05.
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serum DHT level was signicantly reduced in the VISPO oral treatment group by 1.29-fold at the end of the study
compared to that at baseline (p<0.001). This change in the DHT level was signicant compared to that in the placebo
(p<0.001). However, the VISPO topical treatment group showed no signicant change in DHT from baseline to the end
of the study compared to the placebo group (Figure 5B). These data clearly suggest that oral administration of VISPO
could markedly inhibit 5α-reductase activity, and thus, the accumulation of DHT in the subjects.
Safety Evaluation
The topical formulations used in this study showed cutaneous tolerability based on investigator and subject self-
assessments.
Serum biochemical analysis showed no signicant changes in liver function parameters (aspartate aminotransferase
AST and alanine aminotransferase (ALT) from baseline to the end of the study. Serum creatinine levels were signicantly
reduced from baseline to the end of the study in all treatment groups (p<0.05). No signicant changes were observed in
BUN levels of the treatment groups during the study (Table 7). The hematological parameters were within the normal
range, except for some marginal variations (Table 8). Vital signs were within normal levels in all subjects in all groups
throughout the study (data not shown).
Table 5 Subject Self-Assessment – Hair Growth Satisfaction Scale (HGSS)
Group A
VISPO – Oral
N = 18 n (%)
Group B
Placebo – Oral
N = 19 n (%)
Group C
VISPO – Topical
N = 18 n (%)
Group D
Placebo – Topical
N = 18 n (%)
p-value
(A vs B)
p-value
(C vs D)
Overall appearance
Decreased 0 (0) 0 (0) 0 (0) 2 (11.11) 0.092
‡
0.344
‡
Increased 6 (33.33) 2 (10.53) 2 (11.11) 2 (11.11)
No change 12 (66.67) 17 (89.47) 16 (88.89) 14 (77.78)
The appearance of the thinning scalp
Decreased 0 (0) 1 (5.26) 0 (0) 1 (5.56) 0.170
‡
0.597
‡
Increased 6 (33.33) 2 (10.53) 2 (11.11) 2 (11.11)
No change 12 (66.67) 16 (84.21) 16 (88.89) 15 (83.33)
The area of thinning scalp
Decreased 0 (0) 1 (5.26) 0 (0) 1 (5.56) 0.170
‡
0.597
‡
Increased 6 (33.33) 2 (10.53) 2 (11.11) 2 (11.11)
No change 12 (66.67) 16 (84.21) 16 (88.89) 15 (83.33)
The amount of hair covering the scalp
Decreased 0 (0) 0 (0) 1 (5.55) 1 (5.56) 0.092
‡
0.833
‡
Increased 6 (33.33) 2 (10.53) 1 (5.55) 2 (11.11)
No change 12 (66.67) 17 (0.89) 16 (88.89) 15 (83.33)
New hair growth
Decreased 0 (0) 0 (0) 0 (0) 0 (0) 0.092
‡
1.000
‡
Increased 6 (33.33) 2 (10.53) 2 (11.11) 2 (11.11)
No change 12 (66.67) 17 (0.89) 16 (88.89) 16 (88.89)
Note:
‡
Chi square test.
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Ten subjects experienced mild AEs, including a common cold and headaches. The investigator’s diagnosis
revealed that the reported AEs were unrelated to investigational products. None of the participants reported SAEs
during the study.
Discussion
In the present study, oral and topical formulations of standardized SP oil (VISPO) were investigated for hair loss arrest in
male and female patients with AGA. In this study, we compared the formulations with their respective placebo groups.
A 16-week treatment with either formulation of VISPO signicantly arrested hair fall compared with placebo. In
addition, phototrichogram analysis revealed that the VISPO formulations considerably increased hair density from
baseline to the end of the study. These results are consistent with those of previous studies. In a randomized clinical
Figure 3 Effect of VISPO formulations on changes in hair growth parameters – Phototrichogram analysis. (A) Hair density, (B) hair thickness and (C) anagen/telogen ratio.
The data were analyzed by independent t-test. ***p<0.001.
Table 6 Investigator Assessment Scoring of Photographs
Group A
VISPO – Oral
N = 18 n (%)
Group B
Placebo – Oral
N = 19 n (%)
Group C
VISPO – Topical
N = 18 n (%)
Group D
Placebo – Topical
N = 18 n (%)
Vertex
Greatly decreased 0 (0) 0 (0) 0 (0) 0 (0)
Moderately decreased 0 (0) 0 (0) 1 (5.56) 1 (5.56)
Minimally decreased 2 (11.11) 6 (31.58) 0 (0) 4 (22.22)
Unchanged 7 (38.89) 11 (57.89) 17 (94.44) 11 (61.11)
Minimally increased 8 (44.44) 2 (10.53) 0 (0) 2 (11.11)
Moderately increased 1 (5.56) 0 (0) 0 (0) 0 (0)
Greatly increased 0 (0) 0 (0) 0 (0) 0 (0)
(Continued)
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trial, Narda et al reported that a food supplement containing 100 mg of SP showed signicant improvement in the hair
pull test compared to placebo.
15
In another prospective cohort study, a 24-week application of SP-containing hair lotion
increased the total hair count in male AGA subjects by 4.9%.
17
In the self-assessment of perceived treatment efcacy, the VISPO oral group participants responded positively to the
HGI and HGSS scores. In addition, the VISPO group showed a higher proportion of respondents with an increase in
vertex and anterior hair growth in the investigator’s photographic assessment score. These ndings are in line with those
of previous studies, where the oral ingestion of SP showed better patient satisfaction scores in the perceived subjective
assessments than the placebo.
24,25
However, most subjects in the VISPO topical group responded with “no change” in the
subjective assessment.
Figure 4 Representative images showing the changes in scalp hair following 16-week treatment with oral/topical VISPO formulations. (A) Representative photographs
showing the vertex region of the scalp. (B) Phototrichogram analysis performed at baseline and at 8 and 16 weeks.
Table 6 (Continued).
Group A
VISPO – Oral
N = 18 n (%)
Group B
Placebo – Oral
N = 19 n (%)
Group C
VISPO – Topical
N = 18 n (%)
Group D
Placebo – Topical
N = 18 n (%)
Anterior
Greatly decreased 0 (0) 0 (0) 0 (0) 0 (0)
Moderately decreased 0 (0) 0 (0) 1 (5.56) 3 (16.67)
Minimally decreased 4 (22.22) 6 (31.58) 2 (11.11) 4 (22.22)
Unchanged 8 (44.44) 11 (57.89) 15 (83.33) 9 (50.00)
Minimally increased 6 (33.33) 2 (10.53) 0 (0) 2 (11.11)
Moderately increased 0 (0) 0 (0) 0 (0) 0 (0)
Greatly increased 0 (0) 0 (0) 0 (0) 0 (0)
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One of the limitations of the present study is that the duration of treatment was restricted to 16 weeks. Our results clearly
demonstrated that VISPO formulations were effective in reducing hair loss at the end of treatment. However, the formulations
did not signicantly change the anagen/telogen ratio from the baseline to the end of the study. Previously, SP extracts were used
for longer durations to observe a signicant change with respect to perceived efcacy and anagen induction.
15,26
Overall, these
observations clearly suggest that prolonged treatment with VISPO formulations could stimulate hair growth in subjects.
Although no adverse effects were recorded during the study, it should be noted that the study duration was short and the sample
size was small. Another limitation of this study was that we did not use any standard medications for efcacy comparisons.
Experimental studies of SP extracts have demonstrated their anti-androgenic effects as a function of 5α-reductase
inhibition. SP extracts are rich in saturated fatty acids, such as lauric acid, myristic acid, linoleic acid, oleic acid, and
sterols (β-sitosterol), which contribute signicantly to 5α-reductase inhibition.
27,28
These attributes could be responsible
for the observed reduction in DHT levels in subjects after oral intake of VISPO. Interestingly, in the topical VISPO
group, there was no signicant reduction in the serum DHT level from baseline compared to the placebo group. One
possible explanation for this observation is that the topical application of the actives generally results in higher DHT
reduction in the scalp than in systemic circulation.
29
In a recent double-blind study by Piraccini et al, the topical
administration of nasteride showed similar efcacy to that of oral treatment in improving the hair count of subjects, but
with less impact on serum DHT levels.
30
Given that there is a clear DHT inhibition by VISPO oral treatment, it would
Table 7 Safety Evaluation – Analysis of Clinical Chemistry Parameters
Parameter Visit Group A
(N=18) VISPO-Oral
Group B
(N=19) Placebo-Oral
Group C
(N=18) VISPO-Topical
Group A
(N=18) Placebo-Topical
AST (U/L) Baseline 26.44±15.33 0.311
#
24.95±10.16 0.091 22.22±7.18 0.836
#
24.28±9.58 0.065
Week 16 27.61±15.26 21.53±4.13 21.94±10.65 29.06±15.59
Change 1.17±4.74 −3.42±8.36 −0.28±5.60 4.78±10.28
ALT (U/L) Baseline 29.17±15.43 0.731
#
24.05±12.88 0.149 22.61±12.98 0.332
#
27.00±14.00 0.684
Week 16 28.44±15.45 21.11±8.36 21.22±10.90 26.50±12.03
Change −0.72±8.75 −2.95±8.53 −1.39±5.90 −0.50±5.12
Serum creatinine
(mg/dL)
Baseline 0.91±0.24 <0.001
#
*** 0.90±0.14 <0.001
#
*** 0.85±0.16 0.012
#
* 0.88±0.15 <0.001
#
***
Week 16 0.84±0.22 0.81±0.14 0.78±0.19 0.81±0.16
Change −0.07±0.07 −0.09±0.09 −0.06±0.10 −0.07±0.06
BUN (mg/dL) Baseline 10.07±3.02 0.295
#
9.44±2.06 0.535 10.15±3.26 0.549 8.62±2.58 0.311
Week 16 9.37±2.54 9.05±2.36 9.71±2.94 9.27±2.31
Change −0.70±2.75 −0.40±2.73 −0.44±3.06 0.65±2.64
Notes: Values are mean±SD.
#
Paired t-test; *p<0.05 and ***p<0.001.
Abbreviations: N, number of subjects; AST, Aspartate aminotransferase; ALT, Alanine aminotransferase; BUN, Blood urea nitrogen.
Figure 5 Effect of VISPO formulations on the androgenic markers in serum. (A) 5α-reductase expression and (B) dihydrotestosterone (DHT) level. The data were analyzed
by independent t-test. ***p<0.001.
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Table 8 Safety Evaluation – Analysis of Hematological Parameters
Parameter Visit Group A (N=18) VISPO-
Oral
Group B (N=19)
Placebo-Oral
Group C (N=18)
VISPO-Topical
Group A (N=18) Placebo-
Topical
Hb (g/dL) Baseline 13.89±1.94 0.579
#
13.55±2.12 0.722
#
13.18±1.39 0.820
#
13.46±1.64 0.660
#
EOS 13.96±2.10 13.60±1.96 13.15±1.30 13.55±2.06
Change 0.07±0.50 0.05±0.63 −0.03±0.61 0.09±0.89
WBC (cells/mm
3
) Baseline 7426.67
±2074.32
0.820
#
7093.10
±1857.26
0.811
#
7861.67
±1689.33
0.142
#
6938.33
±1308.80
0.837
#
EOS 7362.78
±1992.54
7026.32
±1992.96
7453.89
±1658.60
6869.44
±1020.93
Change −63.89±1171.13 −66.84±1199.46 407.78±1122.87 −68.89±1395.90
Neutrophils (%) Baseline 58.18±7.74 0.213
#
58.35±9.18 0.960
#
59.34±6.37 0.858
#
56.21±7.03 0.269
#
EOS 56.22±8.55 58.26±6.89 59.04±9.16 59.08±9.32
Change −1.96±6.43 −0.09±7.75 −0.30±6.98 2.87±10.67
Lymphocytes (%) Baseline 31.14±6.19 0.073
#
30.86±8.82 0.954
#
29.11±5.73 0.328
#
32.37±8.13 0.433
#
EOS 33.97±7.16 30.96±5.84 30.38±7.83 30.95±8.39
Change 2.82±6.26 0.10±7.46 1.27±5.36 −1.42±7.52
Eosinophils (%) Baseline 3.99±2.57 0.285
#
3.97±2.13 0.798
#
5.18±4.37 0.079
#
3.11±1.79 0.618
#
EOS 3.65±2.34 3.86±2.50 4.45±4.08 2.94±1.74
Change −0.34±1.30 −0.11±1.86 0.73±1.66 −0.17±1.44
Monocytes (%) Baseline 6.19±1.35 0.099
#
6.11±1.93 0.682
#
5.92±1.60 0.436
#
6.01±1.50 0.110
#
EOS 5.78±1.43 6.28±1.64 5.59±1.63 6.70±1.59
Change −0.41±1.00 0.17±1.82 −0.33±1.77 0.69±1.75
Basophils (%) Baseline 0.50±0.27 0.176
#
0.72±0.27 0.092
#
0.44±0.20 0.054
#
0.52±0.24 0.004
#
**
EOS 0.39±0.23 0.56±0.28 0.54±0.21 0.33±0.20
Change −0.11±0.33 −0.15±0.37 0.10±0.21 −0.19±0.24
PCV (%) Baseline 43.17±5.70 0.166
#
42.65±5.69 0.423
#
41.21±3.29 0.413
#
42.36±4.41 0.249
#
EOS 42.54±5.77 42.25±5.11 40.91±3.90 41.62±5.49
Change −0.62±1.82 −0.41±2.15 −0.30±1.52 −0.73±2.61
MCV (fL) Baseline 84.93±9.06 0.371
#
83.85±8.81 0.565
#
79.05±9.00 0.215
#
83.04±7.43 0.332
#
EOS 85.37±9.73 83.53±9.29 79.48±8.72 133.80±215.00
Change 0.21±0.98 −0.15±1.13 0.32±1.06 49.91±211.86
MCH (pg) Baseline 27.43±3.36 0.005
#
** 26.61±3.69 0.110
#
25.55±3.25 0.807
#
26.65±2.82 0.004
#
**
EOS 28.02±3.56 26.94±3.78 25.59±3.14 27.27±2.87
Change 0.59±0.77 0.33±0.86 0.04±0.76 0.62±0.77
MCHC (g/dL) Baseline 32.17±0.78 0.028
#
* 31.69±1.20 0.105
#
32.29±1.81 0.735
#
31.74±0.74 0.012
#
*
EOS 32.78±1.33 32.16±1.63 32.15±1.12 32.52±1.38
Change 0.61±1.08 0.46±1.18 −0.14±1.78 0.77±1.16
(Continued)
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seem there may also be sexual side effects, menstrual effects and mood changes in women, as in case of nasteride.
31,32
However, none of the subjects reported such side effects during the study. The adverse effects reported with oral SP are
mostly limited to mild gastrointestinal issues like nausea, diarrhea and constipation.
33
In addition to its anti-androgenic action, SP extracts have been demonstrated to mediate hair regrowth in murine
models via transforming growth factor-β (TGF-β) signaling.
34
Further, SP formulations have been reported to exert anti-
inammatory effects in human keratinocytes.
35
There are reports that β-sitosterol, the key constituent of SP, can instigate
vascularization through its angiogenic ability.
36
Based on these reports, it can be presumed that VISPO potentiates hair
loss arrest by its anti-androgenic effect and further supports hair regrowth via stimulation of growth factors and
neovascularization in the scalp.
Most clinical studies have been conducted with SP extract as an ingredient in formulations containing other active
ingredients, such as vitamins and minerals.
15,16
In such a scenario, it is difcult to ascertain the contribution of SP extract
to hair care. In contrast, in the present study, the observed efcacy of the product (VISPO) could be attributed to SP
extract alone. VISPO supports hair growth by reducing hair fall and increasing the hair density. This study provides
further insights into the functionality of SP as key ingredient in hair care.
Conclusion
A 16-week treatment of AGA patients with oral and topical formulations of VISPO was effective for hair fall arrest.
Furthermore, oral ingestion of VISPO signicantly inhibited 5α-reductase activity and hence reduced DHT accumulation
in the subjects. Though the data from this study provide limited evidence on the topical application of VISPO, long-term
treatment with these formulations may be required to establish the complete efcacy of VISPO for hair regrowth in
patients with AGA. Overall, VISPO can be effectively used as an active ingredient in functional and cosmetic
formulations.
Data Sharing Statement
The data sets used and/or analyzed during the current study available from the corresponding author on reasonable
request.
Acknowledgments
The authors acknowledge Mr. Sathish Mukashi, Vin Super Foods, Bangalore, India, for assistance with the formulation
development.
Disclosure
The investigational product VISPO
TM
is a proprietary extract manufactured by Vidya Herbs Pvt., Ltd. Heggar
Venkataramana Sudeep, Richards Aleksander, Kuluvar Gouthamchandra, and Kodimule Shyamprasad are employed by
Vidya Herbs Pvt. Ltd., and Sriram Rashmi s employed by the BGS Global Institute of Medical Sciences, Bangalore,
India. Thomas V. Jestin s employed by Leads Clinical Research and Bio Services Private Ltd. (Bangalore, India). The
authors declare no conicts of interest.
Table 8 (Continued).
Parameter Visit Group A (N=18) VISPO-
Oral
Group B (N=19)
Placebo-Oral
Group C (N=18)
VISPO-Topical
Group A (N=18) Placebo-
Topical
Platelet count
(Lakhs/cm
2
)
Baseline 2.86±0.60 0.610
#
3.27±0.98 0.333
#
2.95±0.65 0.953
#
2.67±0.76 0.682
#
EOS 2.80±0.59 3.17±1.01 2.95±0.67 2.73±0.70
Change −0.06±0.45 0.10±0.43 0.00±0.27 0.05±0.55
Notes: Values are mean±standard deviation (SD).
#
Paired t-test; *p<0.05 and **p<0.01.
Abbreviations: N, number of subjects; Hb, Hemoglobin; WBC, White blood cell; PCV, Packed cell volume; MCV, Mean corpuscular volume; MCH, Mean corpuscular
hemoglobin; MCHC, Mean corpuscular hemoglobin concentration; cmm, cubic millimeter; g/dl, gram/deciliter ; fL, femtolitres; pg, picograms.
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