Oat® Cosmetics: Oat® COM Extruded Colloidal OatmealPrepared by Oat® Cosmetics

What is Colloidal Oatmeal?

• The finely milled whole oat kernel including the bran.

• The bran contains the majority of the active constituents of the oat kernel.

• Colloidal oatmeal is not a true colloid:- A colloid is a system in which finely divided particles are dispersed

within a continuous medium in a manner that prevents settlement.

• It is monographed in the US by FDA as a skin protectant

• In order to meet the requirements of the monograph it must meet the requirements of the USPC

Oat® COM- Colloidal Oatmeal Skin Care Benefits compared with..

OCCLUSIVE HUMECTANT BARRIER REPAIR ANTIOXIDANTS ANTI-

INFLAMMATORYANTI-

IRRITANT

COLLOIDAL OATMEAL

MACADAMIA NUT OIL

DIMETHICONE MINERAL OIL PETROLATUM HYALURONIC

ACID GLYCERIN

CERAMIDES CHOLESTEROL

Molecules in Oats

Oat Actives Activity Application

Avenanthramides• Anti-irritant and redness reduction (Anti-histamine

effect similar to Tranilast) • anti-oxidant activity (such as superoxide dismutase)

Soothe & relieve dry skin

Avenacins (Saponins)

• Anti-inflammatory and immuno-regulatory properties in the treatment of atopic dermatitis (AD). Skin cleansing properties through sebum

Flavonoids • Antioxidants (Anti-carcinogenic??) Anti-microbial

Simple & Complex Phenolics

• Antioxidants, Prevention of lipid peroxidation, anti-inflammatory? Anti-pruritic

eta-Glucan• Immuno – stimulant• Reduce fine lines and wrinkles• Hydrating agent

Skin MoisturiserWound Healing

Lipids/Oils • 65% triglyceride, Vitamin E, phospholipids.• Effective emulsifying and antioxidant activity

Replenish skin provide pH buffering Vitamin-E precursors

Starch • Adsorption and absorption properties• Physical barrier

Oat Peptides • Collagen and elastin promoters by stimulation of the fibroblasts.

Skin pH Buffering Maintains barrier integrity

Avenanthramides

• A group of 20-30 naturally occurring polyphenols found in oats (Avena sativa L.)

• Strong anti-oxidant properties• A powerful anti-inflammatory and anti-histamine• Reduces redness

Anti-irritant activity of avenanthramides. Erythema was calculated 24 hours after irritation with 1.5 minimal erythema dose UV light, with oat fractions diluted in 50% ethanol to a constant volume, relative to baseline.

Adapted with permission from Schmaus et al.

Range seen in product with Oat® COM 3-5% inclusion

Oat β-glucan

• Unbranched linear glucose polymer• 1 → 4 glycosidic links (x4)• 1 → 3 glycosidic links (x1)

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H

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H

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HO

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What is Oat® COM- Extruded Colloidal Oatmeal

• The high beta-glucan variety ‘Peppi’ is grown by selected farmers in Finland

• Manufactured by patented process resulting in:

• Optimised activity and functionality

• Excellent microbial purity

• Enhanced bioavailability of phytochemicals

• Enhanced rheological characteristics

• Very small particle size imparting excellent textural properties

• Effective lipid and water binding properties enhancing emulsion stability

Enhanced Colloidal Stability

• Non-extruded vs. Oat® Cosmetics Oat® COM

• 5% Suspension

• Centrifuged 3000rpm 10 min

Left: Competitor Colloidal OatmealRight: Oat® COM USP

Enhanced Colloidal Stability: Zeta Potential

• Oat® Cosmetics’ Oat® COM shows significantly higher Zeta potential, therefore presents enhanced stability over a wider range of temperatures and pHs

Zeta potential [mV] Stability behaviour of the colloid

from 0 to ±5, Rapid coagulation or flocculation

from ±10 to ±30 Incipient instability

from ±30 to ±40 Moderate stability

from ±40 to ±60 Good stability

more than ±61 Excellent stability

Zeta Potential: Standard Colloidal Oatmeal Zeta Potential: Oat COM USP

Enhanced availability of Oat β-Glucan

• Oat β-glucan is a key component of Oat® COM for cosmetic use

• The higher the Oat β-glucan content, the more effective your formulations will be at delivering these highly desirable results

• A higher oat β-glucan can be demonstrated by rheology.

Oat® COM [red] vs. Competitor Colloidal Oatmeal[black]

High Microbial Purity

Disinfectant chemicals Irradiation* Autoclaving UHT

InletMoisture

OutletMoisture

Water Activity

Microbescfu/g

Yeastcfu/g

Mouldscfu/g

Flour 13% 0.6 7 X 105 5400 730

Test 1 13% 7.5% 0.4 <10 <10 <10

Test 2 19% 12.2% 0.6 <10 <10 <10

Test 3 13% 7.2% 0.3 <10 <10 <10

Test 4 19% 11.9% 0.6 <10 <10 <10

• Note: when moisture of our oat flour is 7,5%, the water activity is about 0,45. When Aw is lower than 0,6 there is no microbe proliferation.

*Except Oat® COM IRR

Oat® COM Colloidal Oatmeal Oil Binding Capacity

Oil binding capacity:

• Oat® COM demonstrates an enhanced capacity to absorb and bind oil

Colloidal Oatmeal Weight increase (g) Average Weight Increase (g)

Average Oil binding (g/100g)

Standard 3.02 3.00

60

1.2 2.98

1.3 3.02

COM 3.91 3.89

78

2.2 3.92

2.3 3.9

Absorbs 30% more oil than standard colloidal oatmeal

Oat® COM Colloidal Oatmeal Oil Binding Capacity

How grea

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y would yo

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the crea

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pplication?

How quickly

did the c

ream ab

sorb?

How greas

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y did yo

ur skin

feel

immed

iately

after

applica

tion?

How moist

urised

did your s

kin fe

el immed

iately

after

use?

How grea

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y did yo

ur skin

feel 5

minutes

after

applica

tion?

How moist

urised

did your s

kin fe

el 5 m

inutes aft

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How would you ra

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roduct a

s a dail

y moist

uriser?

2.50

3.50

4.50

5.50

6.50

7.50

8.50

3.093.73 3.59

7.41

5.41

6.687.09

5.45 5.77 5.86

7.647.09 7.09

7.77

Short Term Placebo Double Blind Trial Results

Placebo averageTest averages

Aver

age

ratin

g be

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- 10

Extruded Colloidal Oatmeal 90 Day Trial - Methodology

• Independent consumer research facility conducted a single placement

study

• 53 female subjects all over 40 years old applied test cream once a day to

face

• 3 skin types equally represented, normal, dry and sensitive

• Assessed after 30, 60 and 90 days

Extruded Colloidal Oatmeal 90 Day Trial - Methodology

• Test cream was a market relevant passive base formulation with a 3% extruded Colloidal Oatmeal inclusion:

Trade Name INCI % w/w FunctionOat® COM Extruded

Colloidal OatmealAvena sativa Kernel Flour 3% Rheology, Emolient,

Active

Oat® Lipid e Avena sativa Kernel Oil 3% Emollient

Arlatone 2121 Sorbitan Stearate, Sucrose Cocoate 3% Emulsifier

Cetyl Alcohol Cetyl Alcohol 1% Co-emulsifier

WhiteParaffin Petrolatum 2.5% Emollient

Mineral Oil Paraffinum Liquidum 8% Emollient

Sunflower Oil Helianthus Annuus Seed Oil 3% Emollient

Sepigel 305 Polyacrylamide, C13-14 Isoparaffin, Laureth-7 2.5% Thickener, stabiliser

Neolone CapG Caprylyl Glycol, Methylisothiazolinone 1% Preservative

Purified Water Aqua to 100%

Extruded Colloidal Oatmeal 90 Day Trial – Overview of finds

Skin feeling moisturised Skin feeling silky soft Soothed the skin0%

10%20%30%40%50%60%70%80%90%

87% 83%

76%87% 83%

74%85% 74%

69%

Long Term Skin Trial Results Combined Cohort

30 Days60 Days90 Days

Perc

enta

ge o

f sub

ject

s tha

t 'ag

reed

'

Skin feeling moisturised Skin feeling silky soft Soothed the skin Nourishes the skin0%

10%20%30%40%50%60%70%80%90%

100%94% 100%

81%100%

100% 94%

94%94%

100% 80%

93%100%

Long Term Skin Trial Results Dry Skin Cohort

30 days60 Days90 Days

Perc

enta

ge o

f sub

ject

s tha

t'agr

eed'

Extruded Colloidal Oatmeal 90 Day Trial – Industry Reaction

Ed Galley at Ed Galley Associates

“The key result and one that in our opinion was very challenging across individuals with dry skin, was on-going and consistent moisturisation When subjects with dry skin conditions test moisturisers, we often expect to see good short-term observations, however long-term and sustained moisturising effects are rare. Dry skin conditions are often accompanied with related issues such as redness or flaking. Therefore the highly perceived soothing effects were also very encouraging indeed.”

Oat® COM Reparative Properties

Clinical Trial Reparative properties of Oat® COM

• In-vivo clinical trial

• Assessed skin barrier damage repair properties of Oat® COM

• Study carried out on 15 healthy adult subjects over a 10 day period

• Two skin areas on the volar forearms pre-irritated

• One area covered with an occlusive patch coated with 0.6% Oat® COM and the other an uncoated control

• Test sites were assessed at day 0, after 24 hours, 5 days

• Rate of recovery compared

Clinical Trial Test Results

Oat® COM patch

Control patch Oat® COM patch

Control patch Oat® COM patch

Control patch

Corneometer Tewameter Visual Grading Assessments

17.5 17.715.61 15.61

2.4 2.43

24.423.2

10.54 11.59

01.43

Results from corneometer, tewameter and visual grading assessments

1 5

Day

(g/h/m2)

Evaluates the water barrier function of the skin

(Visual grade units)

Visually evaluates and scores skin irritation

(Corneometer Units)

Determines the hydration levels of the skins surface

Clinical Trial Visual Assessment Grading Scale

Grade Unit Visual Assessment Grading Scale

0.0 No apparent cutaneous involvement

0.5 Faint, barely perceptible erythema or slight dryness (glazed appearance).

1.0 Faint but definite erythema, no eruptions or broken skin or No erythema but definite dryness; may have epidermal fissuring.

1.5 Well-defined erythema or faint erythema with definite dryness, may have epidermal fissuring.

2.0 Moderate erythema, may have a very few papules or Deep fissures, moderate-to-severe erythema in the cracks.

2.5Moderate erythema with barely perceptible oedema or severe erythema not involving a significant portion of the patch (halo effect around the edges), may have a few papules or moderate-to-severe erythema.

3.0 Severe erythema (beet redness), may have generalised papules or moderate-to-severe erythema with slight oedema (edges well defined by raising).

3.5 Moderate-to-severe erythema with moderate oedema (confined to patch area) or moderate-to-severe erythema with isolated eschar formations or vesicles.

4.0 Generalised vesicles or eschar formations or moderate-to-severe erythema and/or oedema extending beyond the area of the patch.

Clinical Trial Test conclusions

• Results confirmed Oat® COMs anti-irritant capability

• Showed Oat® COM supported the increased repair rate of the skin

• Oat® COM had statistically significant better recovery of – skin hydration – skin cracking – visual erythema

• Reparative properties caused by the interaction of the oat beta–glucan and anti-oxidants (Avenanthramides)

• Oat® COM’s patented process enhances the bio-availability of these molecules

Oat Sensitisation

Reports of Oat Sensitization

Study N Age Design Formulation Tests Results

Boussalt, 2007 1 302 • Prospective

• Open Oat pollen• APT• SPT• OFC• ROAT

15% APT+19% SPT+16% OFC+

7/25 ROAT+

Pigatto, 1997 2

42 (atopic)22 (control) 6-24 months • Double blind

• RandomizedColloidal oat

extract• Topical

applicationNo urticarial or contact allergy

reactions

Grimalt, 2007 3 173 (atopic) < 12 months • Open label

• 6 weeksOat-based emollient

• Steroid sparing effect

42% decrease in usage of moderate and high potency topical corticoids

Goujon, 2009 4 12 (atopic) Adults • Open label

• 45 days

Oat-containing

cosmetics and oat extracts

• APT• SPT• RMA

No immediate or delayed reactions

APT=atopy patch testing; OFC=oral food challenge; RMA-repeated and maximized applications; ROAT-repeated open application test; SPT=skin prick test.

1. Boussault P, et al. Allergy. 2007;62(11):1251-1257. 3. Grimalt R, et al. Dermatology. 2007;214(1):61-672. Pigatto P, et al. Am J Contact Dermat. 1997;8(4):207-209. 4. Goujon C, et al. Dermatology. 2009;218(4):327-333.

Source: AveenoMD

Topical Oat Safety

• Not common for food to cause disease flares in atopics

• Oats have not been reported as common offenders

• Studies of oat-based products applied topically show no tendency toward adverse events

• Safe and effective in the treatment of the vast majority of individuals

Source: AveenoMD

Oat® COM Summary

Benefits of our Unique Oat® COM – Colloidal Oatmeal

• Leaves luxurious silky feel on the skin

• Consumer trust in oats is at all time high

• Proven efficacy through independent skin trial

• Full traceability of ingredient from field to face

• Sustainable best agronomic practice / methods of farming

• Proven natural ingredient

Consumer Benefits of Oat® COM

• Recognised by the Food and Drugs Administration [FDA] as a skin protectant, ECOCERT and COSMOS certified

• Breadth of application in skin care & cosmetic products

• Proven efficacy in cosmetics and personal care products:- Moisturising- Cleansing- Anti-irritant- Anti-itch- Anti-inflammatory- Humectant- Occlusive - Antioxidant - pH buffering properties

Angus RobertsonBusiness Development

Oat Cosmetics02380 767 228ar@oat.co.uk