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54 中国美容医学2016年12月第25卷第12期 Chinese Journal of Aesthetic Medicine.Dec.2016.Vol.25.No.12
High dose niacin in the treatment of acne vulgaris: a pilot study
JIANG Hao1. MD, LI Chang-yi1. Prof.
(Department of Dermatological and Clinical Research, The First Afliated Hospital of Guangxi University of Chinese Medicine,
Nanning 530023, Guangxi, China)
Abstract: Introduction Acne patients are frequently associated with abnormal lipid prole. It may be useful to apply high dose
of niacin that regulates the lipid prole along with acne treatment. There is no report about high dose of niacin in treatment of
acne. Objective To evaluate the therapeutic effect and safety of high-dose niacin in acne vulgaris. Methods Acne patients
were randomly allocated to two treatment groups. Both groups were treated orally with the tablets for 12 weeks; the niacin
group at an increasing dose of niacin tablet: 2000 mg (40 mg/kg/d). The control group (nicotinamide group) at a dose of
nicotinamide tablet: 600 mg (10 mg/kg/d). All patients were asked not to consume certain foods such as milk and alcohol.
A high-protein, low-fat and low-glycemic-load diet was recommended in both groups. Results A total of 108 patients were
nished the study. Niacin group: 56 patients; control group: 52 patients. After 12 weeks of treatment, niacin and nicotinamide
caused improvement in acne patients. Percentage Improvement in the niacin group (82.37±7.837) %was signicantly higher
than in the nicotinamide group (63.19±10.18)%,
P
<0.01. The number of successful cases in the niacin group was signicantly
higher than in the nicotinamide group after 12 weeks of treatment, (
χ
2 = 10.55,
P
<0.01). Conclusions High dose niacin can
really do it work in treatment of acne vulgaris. The therapeutic effcct of High dose of niacin in treatment of acne vulgaris is
more effective than nicotinamide.
Key words: niacin; nicotinamide; acne vulgaris; acne; Vitamin B3
Contact Information for Corresponding authors: Jiang Hao. MD.
Laboratory of Medical Molecular Biology & Clinical Research Department,The First Affiliated Hospital of Guangxi
University of Chinese Medicine. Dongge Road No.89-9; Nanning city, Guangxi, China. 530023
E-mail: Johnjianghao2005@126.com
Introduction
Acne vulgaris is a chronic inflammatory disease of the
pilosebaceous glands resulting from androgen-induced,increased
sebum production, altered keratinisation,and inflammation[1].
It has been reported that abnormal lipid oxidation plays a
major role in acne inflammation[2-4].Acne patients, males and
females, had signicantly low plasma high density lipoprotein
cholesterol (HDL-C) levels. Plasma triglycerides and low
density lipoprotein cholesterol (LDL-C) levels in severe cases
of acne were shown to be significantly elevated compared
with those in healthy controls[5]. Acne patients are frequently
associated with abnormal lipid prole [6]. Lipoprotein (a) [LP(a)]
in male and female patients with mild, moderate and severe
acne was signicantly higher than in the healthy control group.
The constituent ratio of male and female patients with TC, TG,
LDL-C and LP(a) over the normal range were significantly
higher than in the healthy control group[6]. Obese females with
acne, compared with obese females without acne and nonobese
subjects, had significantly higher serum triglycerides,low-
density lipoprotein cholesterol, and apolipoprotein-B (apo-B)[7].
Hyperlipidemia is an important risk factor for atherosclerosis[8-9].
Acne patients have significant changes in the plasma lipid
prole that should be considered in the pathogenesis as well as
in the treatment of acne.
Nicotinamide have been used for the treatment of acne
vulgaris for more than 50 years, and several recent studies have
investigated its efcacy and safety[10-13]. Nicotinamide is involved in
numerous oxidation–reduction reactions in mammalian biological
systems, essentially acting as an antioxidant[14]. The mechanism
of action of nicotinamide in the treatment of acne vulgaris
includes an anti-inflammatory effect via inhibition of leukocyte
chemotaxis, lysosomal enzyme release, a bacteriostatic effect
against Propionibacterium acnes, and decreased sebum production.
In the clinical studies, niacinamide significantly decreased
hyperpigmentation and increased skin lightness; the mechanism
occurs by inhibiting melanosome transfer from melanocytes to
keratinocytes[13-14]. Other possible mechanisms involve suppression
of vascular permeability and inflammatory cell accumulation, as
DOI:10.15909/j.cnki.cn61-1347/r.001491
Jiang Hao, Li Chang-yi. High dose niacin in the treatment of acne vulgaris: a pilot
study. Chinese Journal of Aesthetic Medicine. 2016,25(12):54-59
55
中国美容医学2016年12月第25卷第12期 Chinese Journal of Aesthetic Medicine.Dec.2016.Vol.25.No.12
well as protection against DNA damage[15]. Therapeutic effect of
nicotinamide in control group may avoid Medical disputes and ease
the doctor-patient relationship of the study.
Niacin, also known as nicotinic acid, though it is
converted to nicotinamide in vivo, niacin and nicotinamide
are different compounds[16-17]. Niacin has different
pharmacological effects to nicotinamide. Serum lipid levels
can be modied by niacin and skin capillaries can be dilated
by niacin to cause flushing. Nicotinamide does not have
the same lipid-modifying effects as niacin. These special
pharmacological effects of niacin and nicotinamide may
produce different therapeutic results in the treatment of
acne vulgaris. Although serious hepatic toxicity from niacin
administration has been reported, it is largely confined to
the use of slow-release formulations given as unregulated
nutritional supplements[18-19]. Laboratory abnormalities
that are usually small (≤10%) and clinically unimportant
include increased prothrombin time, increased uric acid,
and decreases in platelet count and serum phosphorus. The
perception of niacin side effects is often greater than the
reality. The therapeutic effects of immediate-release niacin in
the treatment of acne are observed in this study.
Materials and Methods
Ethical committee clearance was obtained before
undertaking this study, and informed consent was also obtained
from all subjects. Clinical data were collected from outpatients
at the Department of Dermatology, the rst afliated Hospital of
Guangxi University of Chinese Medicine, China. Patients with
mild, moderate-to-severe, symmetric facial acne vulgaris were
recruited.
Random numbers were generated by computer, and type
of treatment programs were written on cards sealed in opaque
envelopes. Acne patients can select a envelope with random
number, in which the Patient’ information was filled and
treatment programs were implemented according to the clinical
manifestation of patient.
Exclusion criteria were therapy of oral isotretinoin,
antibiotics, topical agents, or phototherapy during the 4 weeks
preceding the trial; pregnancy or lactation; patients with a
history of allergies, or heart, liver, or kidney dysfunction; and
those who could not tolerate the side effects of niacin.
The niacin group was treated orally with niacin tablets.
On day 1, the patients received 100 mg, four times daily
(qid); on day 2, 200 mg, qid; on day 3, 300 mg, qid; on day
8, 400 mg, qid; on day 9, 500 mg, qid. The niacin dosage was
gradually increased to 2000 mg/d (500 mg, Qid; 40mg/kg/d) in
the second week. The nicotinamide group was control group,
the patients were treated orally with nicotinamide tablets at a
dosage of 200 mg tid (600 mg/d, 10 mg/kg/d). Both niacin and
nicotinamide group were also treated with folic acid(10mg, tid),
vitamin B6(20mg, tid), vitamin B12(50μg, bid). A high-protein,
low-fat, low-glycemic-load diet and drinking more water was
recommended in both group. Drug treatment time was 3 months.
All patients were asked not to consume certain food, such
as chili, milk, beef, fried food (eg., fried chicken, French fries,
grilled steak), beer, or liquor during treatment. The acne patients
and their parents in both groups were patiently informed that the
drugs may cause ushing but that it is not an allergic reaction.
No antibiotics were used in either group.
Efficacy and safety assessment
Hayashi scoring in assessing the severity in acne patients
was used[20]. In 2008, Hayashi et al. used lesion counting to
classify acne lesions into four groups[20]. They classified acne
based on the number of inammatory eruptions on half the face
as 0-5: mild; 6-20: moderate; 21-50: severe; and more than 50:
very severe.
Acne lesion counts were done visually twice a month
to evaluate changes in the number of inflammatory lesions
(papules or pustules) and to check any side effects that might
appear systemically or topically. The total of inflammatory
acne and non inflammatory acne lesion on the face, back,
chest and back neck (Acne Keloidalis Nuchae[21]) of the
body were scored to assess the progress of acne. After 12
weeks of treatment, success was assessed according to the
Investigator's Global Assessment scale[22-23]: clear—residual
hyperpigmentation and erythema may be present, the facial
skin is clear and almost clear; almost clear: a few scattered
comedones and a few (≤5) small papules (improving) on
face[22-23]; clear and almost clear is successful case. Not clear—
Patient has greatly improved after treatment, but the facial
skin is not clear, comedones, mild papules (new inammatory
lesions) can be found on the face, not clear case.
The percentage improvement in lesion count was calculated
with the following equation:
[(baseline lesion counts –lesion counts after weeks
treatment) / baseline lesion counts]×100%.
基础研究
56 中国美容医学2016年12月第25卷第12期 Chinese Journal of Aesthetic Medicine.Dec.2016.Vol.25.No.12
Larger inflammatory papules, pustules, symmetric acne
and cysts equal to or larger than 6 mm in diameter were counted
as two acne lesions.
Side effects and tolerance of niacin would be ascertained
by asking the patient at each visit about any abnormal effect
that appeared throughout the course of treatment. Also at each
visit, the investigator rated the severity of the niacin symptoms
of flushing (warmth, itching, redness, or tingly feeling on the
skin) on a scale ranging from 0 (absence), 1 (mild: comfortable),
2 (moderate: uncomfortable but tolerable), to 3 (severe:
uncomfortable and intolerable)[22]. The laboratory tests included
complete blood counts and liver function at the beginning of and
after treatment.
Statistical analysis
The homogeneity of variance test was used to compare
patients’ ages and total acne score before treatment. Student’s t
test and one-way analysis of variance were used to compare the
signicance of the mean percentage improvement between the
treatment groups at different times. The chi-squared (
χ
2) test
was used to compare the treatment success rates in the niacin
and nicotinamide groups after 12 weeks of treatment. For all
comparisons, a signicance level of 0.05 (
P
＜0.05) was used.
Results were represented as the mean ± standard deviation
(x
¯±s).
Results
Patient disposition and baseline characteristics (Table 1)
A total of 112 patients (age range, 14 to 30 years) were
randomised into two treatment groups, the niacin group and the
nicotinamide group. Three patients dropped out of the niacin
group and one dropped out of the nicotinamide group. The
niacin group included 56 patients (23 male, 33 female, with a
mean age of 20.5714±4.12 years; the nicotinamide group had
52 patients (25 male and 27 female; mean age, 19.9231±3.95
years). Both groups were of similar size and well matched at
baseline with respect to age, sex, duration.
Efficacy evaluation (Table 1 and Figure 1)
Acne patients had their niacin dosages increased 2000 mg
(500 mg, tid) by the two weeks of treatment. Acne lesion on
the face, back, chest and back neck (Acne Keloidalis Nuchae)
of the body are healed by niacin treatment. Improvement in the
niacin group was more than 80% after 12 weeks’ treatment.
Response of the acne lesions to niacin was superior to that of
nicotinamide and this difference was statistically signicant
(
P
＜0.01). Improvement in the niacin group increased rapidly,
and it was signicantly higher than in the nicotinamide group
for several weeks (
P
＜0.01) (Table 1,Figure 1). Improvement
in the niacin group was significantly higher than in the
nicotinamide group over different treatment periods (
P
＜0.01)
(Table 1). The number of successful cases in the niacin group
was significantly higher than in the nicotinamide group
after 12 weeks of treatment (Table 1). Figure 3 to 6 shows
Percentage improvements: *, The mean percentage improvement in the niacin group was signicantly higher than in the nicotinamide group,
P
＜0.01;
Clear and Not clear Cases after 12 weeks of treatment: ◆, According to the Investigator's Global Assessment scale, the constituent ratio of Clear cases in the niacin
group was signicantly higher than in the nicotinamide group after 12 weeks of treatment,
χ
2=10.55,
P
＜0.01
57
中国美容医学2016年12月第25卷第12期 Chinese Journal of Aesthetic Medicine.Dec.2016.Vol.25.No.12
the photos of a patient before, during, and after 3 months of
niacin treatment (500 mg, Qid).
Safety evaluation (Figure 2)
Flushing was experienced by all the patients (100%) in the
niacin group. It was frequently accompanied by heat, itching,
or a prickly sensation on the upper part of the body. These
symptoms appeared at the same time. Flushing appears 10-30
min after taking niacin (35.7% experience it in 10 min; 37.5%,
in 15 min; 26.78%, in 20 min), and it usually lasts for about
20 to 30 min (82.14%), though it can sometimes last up to 1 h
(17.85%) during the rst 2 weeks of treatment. Flushing (prickly,
hot, and itching) was transient, peaking during the second
week of treatment and decreasing over time. After 4 weeks of
treatment, the symptoms of niacin flushing had disappeared
(Figure 2). Seven patients (12.5%) experienced mild stomach
discomfort (dull ache, abdominal distension) after taking niacin
before a meal, but these symptoms were relieved by drinking
water and eating some food. Four patients (7%) reported dry
skin on cold winter days.
An inflammatory acne lesion developed into a large cyst
on the face of a patient with a severe case during early niacin
treatment. The lesion caused no further deterioration, but it did
not respond readily to the niacin until it had fully liqueed and
softened. The mixture of blood and pus in the cysts was drained
by needle puncture. Three patients discontinued treatment
because they or their families feared the side effects of high-
dosage niacin treatment. There were no trends in haematology
or liver functional parameters indicative of any toxic systemic
effect of the niacin or the nicotinamide.
Discussion
This was a pilot clinical study to evaluate high-dose
niacin in the treatment of acne patients. Improvement in the
niacin group was signicantly higher than in the nicotinamide
group (
P
＜0.01) over the period treatment. Acne Keloidalis
Nuchae (AKN) involves the hair follicles of the occipital base
of the skull and neck. AKN and acne vulgaris were improved;
The papule inflammation was subsided and disappeared,
and the patients’ skin appeared smooth after 12 months of
niacin treatment. The study showed that high dose niacin has
beneficial effects in the treatment of acne (include sever acne
and AKN). Nicotinamide has no vasodilator effect,so it does not
produce flushing of the skin. It takes weeks for nicotinamide
to take a gradual effect on the inflammatory acne lesions.
Although nicotinamide can do it work in treatment of acne,
new inammatory lesions can be more frequently found during
nicotinamide treatment. Acne lesions of most patients do not
clear after 12 weeks of nicotinamide treatment. Nicotinamide in
treatment of acne patients of control group can avoid Medical
Dispute.
Acne vulgaris is a multifactorial disease. It is reported
that certain foods are aggravating factors for acne [24-25]. It
is theorised that diet directly or indirectly influences the
Figure 3 A patient before niacin
treatment
Figure 5 The patient of 8 weeks of
niacin treatment
Figure 4 The patient after 4
weeks of niacin treatment.
Figure 6 The patients of 12 weeks
of niacin treatment
Figure 1 Percentage Improvement of niacin and nicotinamide
Figure 2 Niacin ushing Changes with treatment period
基础研究
58 中国美容医学2016年12月第25卷第12期 Chinese Journal of Aesthetic Medicine.Dec.2016.Vol.25.No.12
pathogenesis of acne vulgaris and the therapeutic effect of
medicine[23-24]. New acne lesions can always be found in patients
who take milk, beef, fried food, or alcohol even they are in
treatment. Therefore, the acne patients in this study were urged
to not consume these foods to prevent new inammatory acne
eruptions and improve the therapeutic effect. Instead, a high-
protein(at least one egg per day), low-fat, and low-glycemic-
load diet[26] was recommended during treatment. Acne lesions
are difcult to be cured unless patients have protein diet every
day. Improvement in acne was more than 80% after 3 months’
treatment with niacin combined with a high-protein diet and
limitation of certain foods and alcohol.
Niacin flushing (itching, warmth, and other related
symptoms) appears about 10 min after niacin ingestion and
lasts for about 30 min. Flushing as a special side effect plays an
important role in strengthening the pharmacological functions
of niacin[27]. The pain symptoms of some acne lesions were
rapidly relieved along with skin flushing. Many patients get
instant therapeutic effect after the rst niacin ushing: the acne
lesions are dissipating and disappearing. Inflammatory acne
lesions subsided after 8 weeks’ treatment, and the small pustules
and papules became dark red and disappeared without leaving
a scar after 12 weeks. However, excessive flushing can be
uncomfortable—even frightening—if the patient is not prepared
for it. In one patient having severe acne, inflammatory acne
developed into a cystic lesion after excessive ushing early in a
high-dose niacin treatment. The large cyst contained a mixture
of blood and pus, and it is suggested that excessive flushing
might cause tiny blood vessels rupture and haemorrhage within
the acne lesion. A medical doctor or a nurse must patiently
explain the niacin flushing and gradually increase the dose of
oral niacin before treatment in order to avoid excessive ushing.
After 4 weeks’treatment with a consistent dose of niacin, the
symptoms of flushing become very mild in most patients and
some no longer had ushing.
In this study, the niacin dose was 2000 mg/d. There
were no trends in haematology or blood chemistry parameters
indicative of a systemic toxic effect of niacin treatment. Mild
stomach discomfort (stomachache, bloating) occurred in a
few patients, but taking niacin with meals or drinking warm
water may relieve the side effects. Drinking more water may
promote uricosuric effect of body. The other side effect of
niacin, Acanthosis nigricans proliferation, was not found in this
research.
Improvement in the niacin group was signicantly higher
than that of the control group during treatment (
P
＜0.01),
possibly because niacin has the pharmacological effect of
modifying lipids[28] and causing mild cutaneous flushing, thus
differing from nicotinamide. We have insufficient evidence to
prove that the secretion of sebaceous glands can be diminished
by niacin, but some patients felt dry and noted reduced sebum
on the facial skin after several weeks’ oral niacin, possibly due
to the serum lipid–regulating effects of that vitamin. Niacin
is the only one drug of regulating plasma lipoprotein(a) level.
Pharmacological doses of niacin dilate the capillaries, promote
micro-circulation, and increase drug concentration around the
lesion, by which strengthen the pharmacological effect.
Weaknesses of the research were:①The number of patients
in the pilot study was small.②Very severe Acne patients and Acne
Inversa need prolonged treatment and increased niacin dosage,
but the dosage for patients in this study was 2000 mg/d. Niacin
dose in treatment of very severe acne and patients associated
with hyperlipidemia can be increasing to more higher(≥3000
mg/d).③Plasma Uric acid were not detected before and after
treatment. But the renal functions of acne patients in both groups
are normal.④We have no enough experience in treatment of
acne by niacin.
The data support the fact that high doses of niacin(≥40
mg/kg/d) are more effective than nicotinamide group for the
treatment of acne. High dose niacin can really do it work
in treatment of acne vulgaris. It is safe and it is tolerated by
patients with gradually increasing the dosage. A high-protein,
low-fat, and low-glycemic-load diet may benefit patients with
acne. Although high dose of niacin treatment of acne needs
further study, its low cost and safety argues for wider used in the
treatment of acne vulgaris.
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Received: 20 May 2016 / Accepted: 15 November 2016
Editor: ZHANG Hui-juan
·告作者读者·
投稿数字写作须知
根据《关于出版物上数字用法的规定》，本刊采用三位分节法（即从小数点算起，向左向右每三位分一节，节间留出一定空隙），
不用千分撇分节法（如 3，216 改为 3 216）。但年份、页数、仪表型号、标准号不用三位分节法。中文出现的数字，凡属计数数值，
一律用阿拉伯数字表示。 本刊编辑部
基础研究
DOI:10.15909/j.cnki.cn61-1347/r.001492
