IMPROVED FACIAL SURFACE SEBUM

AND PORE APPEARANCE WITH

NIACINAMIDE AND SDA

FC02-06

AUTHORS: Rosemarie Osborne, PhD, Rachel Rose-Mansfield, MS,

Akira Matsubara, PhD, Cheri Swanson, PhD

AFFILIATIONS: The Procter & Gamble Company, Cincinnati, Ohio

USA and Kobe, Japan

---

Introduction

• Niacinamide (Vitamin B3) is utilized in numerous topical cosmetic

products to provide beneficial effects for a wide array of common skin

problems such as those associated with aging and photoaging, e.g.,

dryness, red blotchiness, hyperpigmentation, texture problems and fine

lines/wrinkles (1-4). A general mechanism for niacinamide is as a

precursor to the important cofactors nicotinamide adenine dinucleotide

(NAD), its phosphate derivative (NADP), and their reduced forms

(NADH and NADPH).

• Dehydroacetic acid and its more water soluble salts such as Sodium

Dehydroacetate (SDA) have been used as antimicrobial agents in a

range of cosmetic formulations (5).

• A screening program was conducted with a wide range of compounds

and natural extracts to identify potential lipogenesis inhibitors. Two

compounds identified were Niacinamide and SDA.

• This report presents the in vitro responses as well as cosmetic benefits

of Niacinamide and SDA-containing moisturizers for sebum-related

endpoints.

---

Purpose/Objective

• To evaluate effects of Niacinamide and SDA on

lipogenesis in an in vitro model.

• To determine potential cosmetic benefits of daily

use of Niacinamide and SDA-containing facial

moisturizers for sebum, pores and texture

appearance endpoints in a clinical setting.

---

Methods

• In Vitro Sebocyte Assay:

– In vitro sebocytes have been used historically to evaluate effects of compounds on sebum

expression, including sebosuppression (6, 7). Lipid synthesis was detected via incorporation of

radiolabeled glucose over a 3 hour period in the presence of test compound in cultured

sebocytes (6, 7).

• Clinical Studies:

– Niacinamide Product Studies. Two 4-week studies were conducted with a niacinamide (2%)

containing facial moisturizer in Caucasian (U.S) and Japanese female panelists. The cosmetic

product was applied twice daily to the face and compared to the moisturizer base vehicle

control in a double-blind, vehicle-controlled split-face randomized (left-right) study design

(Caucasian study), and as well as compared to baseline (both studies). Facial surface sebum

(Sebutape®) and pore appearance (image analysis) were determined at baseline and up to 4

weeks. Self-assessments of improvements in facial skin appearance were obtained also.

Comparison of treatment groups was accomplished by t-test analysis.

– SDA Product Study. A double-blind study design similar to the that used for the niacinamide

studies was used to evaluate a facial moisturizer containing 0.5% SDA in combination with

3.5% niacinamide as compared to the moisturizer base vehicle control moisturizer. The

panelists were Caucasian (U.S.) women in a 6-week vehicle-controlled split-face randomized

(left-right) study design, evaluating sebum (Sebumeter) and pore (image analysis) endpoints.

Self-assessments of improvements in facial skin appearance were obtained also. Comparison

of treatment groups was accomplished by t-test analysis.

---

In Vitro Results - Lipogenesis

• Niacinamide reduced lipogenesis in a dose-dependent manner, with significant inhibitory

activity observed up to 4.0% (w/v) niacinamide. For example, at 1% niacinamide (Fig. 1)

lipogenesis was significantly reduced to 33% of control levels (p < 0.05, Student’s t).

• SDA and its free acid form, dehydroacetic acid (DA), significantly (p < 0.05) inhibited

lipogenesis by up to 82% over a dose range up to 0.15% in the in vitro lipogenesis assay.

For example, at 0.1% (w/v), SDA and DA inhibited lipogenesis to 45% and 48% of control,

respectively.

Figure 1. In Vitro Sebum Lipogenesis

100

In Vitro Lipogenesis

(% Control)

80

60

40

20

0

*

*

*

1 % Ni ac 0.1%SDA 0.1%DA

*p

---

Niacinamide Product – Surface Sebum & Pores (Caucasian Women)

• Figure 2. Use of a moisturizer containing 2% niacinamide for 4 weeks

led to decreased sebum (Sebutape®) and pores (image analysis) in

Caucasian women significantly vs baseline, and vs the vehicle control

moisturizer.

Sebum & Pore Reduction from Baseline (%)

5

-5

- 15

- 25

- 35

- 45

* *

*

*

2%Niacinamide

Control

Sebum Area Sebum Spots

Pore Count Pore Area

*p

---

Niacinamide Product – Surface Sebum & Pores (Japanese Women)

• Figure 3. Decreased facial skin surface sebum

with use of a 2% niacinamide product for 2 or 4

weeks in Japanese women. Images indicate

Sebutape ® appearance. A majority (88%) of the

panelists reported their skin was less oily.

• Figure 4. Decreased facial pore appearance

with use of a 2% niacinamide product for 2 or 4

weeks in Japanese women. Images indicate

example facial images used for pore image

analysis.

Sebum Reduction from Baseline (%)

0

- 10

- 20

- 30

- 40

*

*

Week 2 Week 4

*p

---

Niacinamide + SDA Product –Surface Sebum & Texture

• Figure 5. Decreased facial skin surface

sebum (Sebumeter) with use of a 3.5%

niacinamide product or a niacinamide + 0.5%

SDA combination product for 6 weeks. A

majority (62%) of panelists reported the SDA

product reduced oily shine better than the

niacinamide alone product.

• Figure 6. Decreased bumpy facial texture/pore

appearance (% texture/pore area fraction) with

use of a 3.5% niacinamide product or a

niacinamide + 0.5% SDA combination product for

6 weeks. A majority (70%) of panelists reported

that the SDA product reduced texture & pores

better than the niacinamide alone product.

Sebum Level

(% Change from Baseline)

0

-5

- 10

- 15

- 20

- 25

- 30

- 35

- 40

- 45

*

Facial Texture/Pores

(% Change from Baseline)

0

-2

-4

-6

-8

- 10

- 12

- 14

- 16

- 18

* † - 20

*

* †

Control Niac Niac+SDA

*p

---

Figure 7. Improvement in Texture and Pores

Baseline

6 Weeks:

Niacinamide + SDA Product

---

Conclusions

• Niacinamide and SDA reduced lipogenesis in an in vitro sebocyte

model (Fig. 1).

• In both Caucasian (Fig. 2) and Japanese women (Figs. 3 & 4), use of a

niacinamide-containing moisturizer reduced surface sebum levels as

well as the appearance of facial pores.

• Use of a moisturizer containing a combination of niacinamide & SDA

led to a significant reduction in surface sebum as compared to

niacinamide product alone (Fig. 5).

• The reduction in surface sebum was paralleled by reduction in uneven

skin texture and pores (Figs. 6 & 7). A majority of the panelists

reported their skin was less oily and had reduced uneven texture and

pores with the combination product.

• These results indicate that facial moisturizers containing cosmetic

ingredients such as niacinamide and SDA are valuable in reducing skin

surface sebum as well as the appearance of uneven facial texture and

pores.

---

References

(1) Matts et al. 2002: A review of the range of effects of niacinamide in human skin.

Intl Fed Soc Cosmet Chem Magazine 5:285-289

(2) Bissett et al. 2003: Topical niacinamide provides skin aging appearance benefits

while enhancing barrier function. J Clin Dermatol 32:S9-S18.

(3) Soma et al. 2005: Moisturizing effects of topical nicotinamide on atopic dry skin.

Int J Dermatol 44:197-202.

(4) Draelos 2005: Niacinamide-containing facial moisturizer improves skin barrier

and benefits subjects with rosacea. Cutis 76:135-141.

(5) Final Report on the Safety Assessment of Sodium Dehydroacetate and

Dehydroacetic Acid (1985). J Am Coll Toxicol 4:123-159

(6) Wheatley VR, Hodgins LT, Coon WM, (1970) Cutaneous lipogenesis. J Invest

Dermatol 54: 288-297.

(7) Seki T, Morohashi M 1993: Effect of some alkaloids, flavonoids and

triterpenoids, contents of Japanese-Chinese traditional herbal medicines, on the

lipogenesis of sebaceous glands. Skin Pharmacol. 6:56-60.

---

This work was funded by P&G Beauty & Grooming