Journal of Cosmetics, Dermatological Sciences and Applications, 2012, 2, 132-135
http://dx.doi.org/10.4236/jcdsa.2012.23026 Published Online September 2012 (http://www.SciRP.org/journal/jcdsa)
Feasibility, Tolerability, Safety and Efficacy of a
Pantothenic Acid Based Dietary Supplement in Subjects
with Mild to Moderate Facial Acne Blemishes
Jillian L. Capodice*
Nutraceutical Medical Research, New York City, USA.
Received May 5th, 2012; revised June 8th, 2012; accepted June 20th, 2012
ABSTRACT
Objective: It has been suggested that pantothenic acid may have antibacterial and skin softening activity. The aim of
this study was to explore the feasibility, tolerability, safety and preliminary efficacy of oral administration of a dietary
supplement containing pantothenic acid in healthy human males and females with mild to moderate facial acne vulgaris.
Methods: An open-label, single arm study of healthy adults who had been previously diagnosed with mild to moderate
acne vulgaris was performed. Subjects were asked to take the study agent, a dietary supplement containing pantothenic
acid, for eight weeks. The primary endpoint of the study was to assess the feasibility of oral administration of the study
agent in subjects over an eight week period. Safety and tolerability were measured utilizing the assessment of adverse
events by the National Cancer Institute’s Common Criteria for Adverse Event Reporting. Secondary endpoints measur-
ing the efficacy of an oral panthothetic acid dietary supplement for the treatment of mild to moderate facial acne utilized
changes in the extent of global facial skin blemishes, assessment of quality of life utilizing the Dermatology Life Qual-
ity Index (DLQI) and analysis of questions about the subject’s beliefs and attitudes towards skin care and lifestyle. Re-
sults: Eleven subjects were enrolled and ten completed the study (90.9%). There were no reported adverse events. Of
the 10 evaluable subjects, the average age (mean ± SD) was 31.8 ± 8. Analysis of the global number of skin blemishes
demonstrated a significant mean reduction in lesion count following the use of the study agent at week 8 (endpoint)
(11.18 ± 6.38, p = 0.02) compared to the average number of baseline blemishes (20.45 ± 10.44). DLQI scores were sig-
nificantly lower at week 8 vs. baseline (p = 0.0194). Conclusions: The results from this study indicated that the admini-
stration of a pantothenic based dietary supplement in healthy human adults with mild to moderate acne vulgaris is feasi-
ble, safe and well tolerated. Secondary analysis shows that administration of the study agent significantly reduced
global facial blemishes. Further randomized, placebo-controlled trials are warranted.
Keywords: Pantothenic Acid; Dietary Supplement; Facial Blemishes; Acne
1. Introduction
Acne is a common disease of the hair follicles in the skin
associated with an oil gland. Acne often appears in teens
but can persist in up to two-thirds of adults [1,2]. Studies
have shown that people with acne may suffer significant
psychosocial burden and report poor quality of life [2].
The mainstays of treatment include over-the-counter and
prescription pharmaceutical drugs including oral and to-
pical antibiotics and retinoids and oral contraceptives [3].
Other procedures include lasers, phototherapy and other
light sources [3]. Recently, approaches from comple-
mentary and alternative medicine (CAM) including the
use of natural products including topical agents contain-
ing vitamin or botanical ingredients, dietary interventions
and acupuncture have been examined [3,4]. Some agents
may have clear mechanisms of action such as vitamins
and dietary supplements like pyridoxine or omega-3 fatty
acids however there is limited data on the use of dietary
supplements in the treatment of dermatologic conditions
such as acne [4]. A recent study found that subjects with
acne were more apt to use CAM based on lower risk,
perceived safety of natural agents, holistic attitudes to-
wards health and improved quality of life, however pro-
spective analysis of various practices and procedures are
lacking and need to be performed in order to determine
feasibility, tolerability and efficacy of these approaches
[4,5]. Given this background we chose to examine the
feasibility, tolerability, and safety of a novel dietary sup-
plement containing pantothenic acid in adult males and
females with mild to moderate skin blemishes. Secon-
*Corresponding author.

Feasibility, Tolerability, Safety and Efficacy of a Pantothenic Acid Based Dietary Supplement
in Subjects with Mild to Moderate Facial Acne Blemishes
133
dary aims were to measure changes in the extent of glo-
bal facial skin lesions and quality of life.
2. Materials and Methods
2.1. Subjects
Healthy human male and female volunteers over the age
of 18, with a previously diagnosed history of acne vul-
garis, more than 10 facial blemishes of any type, able to
understand and sign the informed consent in the English
language and in good health were eligible for the study.
Excluded from the study were subjects taking any oral or
topical prescription drug for acne vulgaris, subjects cur-
rently undergoing treatment for acne vulgaris besides
daily hygienic skin care, known renal or hepatic impair-
ment, scheduled elective surgery or other procedures
requiring general anaesthesia during the study, participa-
tion in another research study involving an investiga-
tional product in the past month, hypersensitivity or
known allergy to any ingredients in the study agent, cur-
rent use of any dietary supplement for skin health (be-
sides a multivitamin), history or presence of gastric ulcer
or duodenal ulcer, history of any gynaecologic condition,
history of any psychiatric disorder and current smoking
or smoking within the past month. The protocol for this
study was conducted under Good Clinical Practice in
concordance with the Declaration of Helinski and it’s a-
mendments.
2.2. Study Procedures
The study was performed between December 2011 and
April 2012. Consecutive human volunteers that met the
eligibility criteria were instructed to read, understand and
sign the written informed consent and model release dis-
claimer. At baseline, subjects were asked to complete
demographic information, have a photograph taken of
their face, complete the Dermatology Life Quality Index
(DLQI), and other health history information. The DLQI
is a general questionnaire that evaluates quality of life
(QOL) in dermatology patients and consists of ten ques-
tions about symptoms, feelings, daily activities, type of
clothing, social or physical activities, exercise, job or
education, interpersonal relationships, marriage relation-
ships, and treatment. Higher scores indicate a poorer
quality of life [6]. Subjects were then assigned to take the
study agent, the dietary supplement, Pantothen (Panto-
thenTM, Avilan Marketing LLC, New York, NY), two
tablets twice a day with food, for eight weeks. Each 4
tablet dose of Pantothen contain the following ingredi-
ents: thiamine—1.5 mg, riboflavin—1.7 mg, niacin—20
mg, pyridoxine—2 mg, folic acid—400 mgc, cyanoco-
balamin—6 mcg, biotin—300 mcg, pantothenic acid—
2.2 g and L-carnitine—733.3 mg. At weeks 4 (mid-point)
and week 8 (end-point) volunteers were asked about their
compliance in taking the study agent and any side effects
and tolerability as measured by the National Cancer In-
stitute’s Common Toxicity Criteria for Adverse Events
3.0 (NCI CTCAE). Subjects were also asked to complete
the DLQI and have a photograph of their face taken. At
the final visit overall satisfaction with the study agent
was assessed using a 5-point scale: 2 = marked im-
provement, 1 = slight improvement, 0 = unchanged, –1 =
worsening, –2 = marked worsening.
2.3. Statistics
The primary feasibility outcome was number of subjects
enrolled versus those completing the study defined as
80% of the volunteers completing the 4-week visit and/or
70% of volunteers completing all 8 weeks of consuming
the study agent. The tolerability and safety outcome was
the incidence of adverse effects, complication/illness and/
or serious medical events due to the study agent as
measured by the NCI CTCAE. The secondary efficacy
outcome of this study was change in the number of
global facial blemishes from baseline to week 8 as meas-
ured by lesion count. Other outcomes were scores on the
DLQI. The number of facial blemishes and DLQI scores
were measured by a paired t-test comparing counts/
scores at baseline (week 0) to week 8. Descriptive analy-
ses were performed for demographics utilizing charac-
teristic measures such as mean, standard deviation, and
range.
3. Results
3.1. Subjects and Feasibility
In total 13 subjects were screened, 11 subjects were en-
rolled and 10 completed the study. The 8-week comple-
tion rate (90.0%) met the feasibility endpoint. Of the 10
evaluable subjects the mean ± SD age was 31.8 ± 8.4.
Demographics and baseline characteristics are summa-
rized in Table 1. The reasons for premature withdrawal
were lost to follow up [1].
3.2. Safety and Tolerability Outcomes
No serious side effects were reported throughout the stu-
dy and there were no reported adverse events.
3.3. Facial Blemishes
The area of the face that was most affected in the study
population was the cheek, followed by the forehead and
chin (60 vs. 20 vs. 20 percent respectively). Analysis of
the number of facial skin blemishes (global acne count)
demonstrated a significant mean reduction in lesion
count from baseline (lesion count 20.45 ± 10.44) to week

Feasibility, Tolerability, Safety and Efficacy of a Pantothenic Acid Based Dietary Supplement
in Subjects with Mild to Moderate Facial Acne Blemishes
134
Table 1. Demographics.
Characteristic Frequency
N 10
Mean age, years ± SD 31.8 ± 8.4
Sex, no (%)
Male 2 (20%)
Female 8 (80%)
Race, no (%)
White 5 (50%)
Black 2 (20%)
Latino 2 (10%)
Asian 1 (10%)
BMI (mean, SD) 24.3 ± 3.8
Baseline global facial lesion 20.45 ± 10.44
Area most predominately affected
Cheek 6 (60%)
Forehead 2 (20%)
Chin 2 (20%)
8 lesion count (11.18 ± 6.38, p = 0.02) (Figure 1(a)).
Figure 1(b) shows a subject at baseline versus week 8
reduction in global acne count in a study participant.
3.4. Dermatology Life Quality Index and Patient
Reported Outcomes
The mean ± SD DLQI score at baseline vs. week 8 was
9.73 ± 4.2 vs. 6.09 ± 2.21, p = 0.0194. 6 of 10 (60%) of
volunteers reported marked improvement, 3 of 10 (30%)
reported slight improvement and only 1 of 10 (10%) re-
ported no change in overall subject satisfaction.
4. Discussion
Pantothenic acid (vitamin B5) is a water-soluble B-com-
plex vitamin that has may have beneficial effects on skin
health. The results of this study demonstrated it was both
feasible and safe for healthy human volunteers with
known mild to moderate acne to take a dietary supple-
ment (PantothenTM) containing pantothenic acid. Our
results also showed that there was a greater than 56%
reduction in the number of global facial blemishes after 8
weeks of Pantothen supplementation. Significantly lower
scores on the Dermatology Life Quality Index corre-
sponding to improved quality of life were also found in
subjects taking the study agent.
It has been suggested that pantothenic acid and some
Baseline Week 8
Student’s t-test week 0 versus week 8
*
(p = 0.028)
25
20
15
10
5
Global Number Facial Lesion
(a)
(b)
Figure 1. (a) Frequency of facial blemishes; (b) Clinical
photograph at baseline vs. week 8.
of its analogs may have antibacterial and skin softening
activity. Pantothenic acid is converted into 4’-phospho-
pantetheine which is then converted to co-enzyme A
(CoA) utilizing adenosine tri-phosphate (ATP) [7-9].
CoA is involved in lipid metabolism and many other
cellular processes and it has been shown that pantothenic
acid may regulate epidermal barrier function through
proliferation and differentiation of keratinocytes via CoA
metabolism [10]. It is possible that the reduction in the
amount of global skin lesions in volunteers following
oral administration of the pantothenic acid based study
agent may function through these mechanisms. However
the exact mechanism of this effect is not understood.
The bioavailability of pantothenic acid has been re-
ported in the range of 40 - 63 percent and amounts found
in 24-hour urine samples have been shown to correlate
with intake [11]. However in the adult with acne, little is
known about the role of co-enzyme A and other factors
which may cause acne including relationships to sebum
production, keritinzation alteration and/or effect on in-
flammatory modulators [12]. While it is uncommon for
adults to suffer from clinically significant pantothenic
acid deficiency, it has been postulated that low levels
and/or dysreuglation of fatty acid metabolism due to

Feasibility, Tolerability, Safety and Efficacy of a Pantothenic Acid Based Dietary Supplement
in Subjects with Mild to Moderate Facial Acne Blemishes
135
pantothenic acid deficiency may be a factor in acne pa-
thogenesis [13]. Even though pantothenic acid is the
main ingredient in Pantothen, there are a number of other
vitamins that may contribute to a synergistic mechanism
of action. This could include the B-complex vitamins and/
or L-carnitine which has been recently shown to reduce
sebum secretion in a human sebaceous cell line [14].
This study also demonstrated improved quality of life
in subjects with facial blemishes as measured by the
Dermatology Life Quality Index. It has been well demons-
trated that adults with acne have reported reduced quality
of life with regard to dissatisfaction and patient bother
[2]. Moreover, it has been suggested that all studies of
acne include assessments of quality of life because such
assessements appear to be important correlates in meas-
uring the success of treatment [15].
The limitations of this study are that we tested feasi-
bility in subjects with heterogeneous lesions, had a small
sample size and no control group. Due to these factors
our exploratory findings cannot be directly attributed to
the administration of the study agent as it is possible that
volunteers improved because they made lifestyle or other
changes that were not reported in their follow up visits.
Strengths of our study include pilot analysis of feasi-
bility and safety that will enable us to better design and
power a larger study and examine potential mechanisms
of action of the study agent and dosage. Given the feasi-
bility, tolerability, safety and positive trend in improving
symptoms and quality of life, a larger randomized, pla-
cebo controlled study of Pantothen is warranted.
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