DSM Nutritional Products Personal Care

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In vivo Efficacy

PENTAVITIN® for Skin Care Feel Deep Hydrating Power

Version 1: December 21, 2011

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Introduction Millions of consumers worldwide are affected by skin conditions that cause unpleasant sensations such as itching, flaking and stinging, or simply an uncomfortably dry and taut feeling. For the tangible relief they seek and require a product that can bind water in the skin and keep it there as long as possible.

PENTAVITIN®, a 100% natural, plant-derived ingredient with both ECOCERT approval and NATRUE certification, perfectly addresses this widespread consumer need. Its effectiveness is based on its unique composition, which is similar to that of the carbohydrate complex found in human skin, and on its unique ability to bind to skin.

Aim of the study Our aim was to proof that PENTAVITIN® improves consequently desquamation and epidermal barrier function of the skin.

Moreover dry skin related sensations such as tightness, itchiness and stinging should be reduced for a more comfortable skin feeling.

Lastly softness and smoothness should be improved and flakiness reduced for a healthy skin appearance.

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Study Design

Study Title: Influence of topically applied PENTAVITIN® on skin parameters

Product: Aqueous solution containing 1% of PENTAVITIN®

Primary objectives: • Influence of a topically applied moisturizer on skin dryness and it’s regression after stopping application

• Influence of a topically applied moisturizer on epidermal barrier integrity of non and artificially damaged barrier

Secondary objectives: • Illustration of the visual effects of a topically applied moisturizer • Evaluation of the subjective appreciation of the organoleptic

characteristics, of the efficacy and the future use

Study population: • Number of subjects: 13 • Average age: 40±1 years (between 35 and 44 years) • Sex: female • Fitzpatrick skin phototype: II (n=7) and III (n=6) • All subjects had dry skin on the legs

Assessment criteria: • Visual grading of dry skin by a clinician • Transepidermal water loss • Macrophotographic illustration • Self-evaluation by the subjects via a structured questionnaire

Test site: Calves

Application & frequency: Twice daily, 15 drops corresponding to approx. 600 μl

Duration: • Wash out phase: 2 weeks • Application phase: 4 weeks • Regression phase: 6 days

Miscellaneous: • All measurements and evaluations were done at least 12h after the last application of PENTAVITIN®

• The subjects were acclimatized for 30 min in an environmental room under standard conditions (24 ± 2°C and 45 ± 5% relative humidity) prior to any measurements

• The subjects used the same shower gel

Test institute: Laboratoire Dermscan, Lyon (F)

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Summary of Study Design

Wash out phase Treatment phase Regression phase

2 weeks 4 weeks 6 days

No application of cosmetics Twice daily application of a 1% aqueous solution of

PENTAVITIN®

No application of cosmetics and of PENTAVITIN®

Shower gel: Sanex dermo hydratant

Shower gel: Sanex dermo hydratant

Shower gel: Sanex dermo hydratant

TEWL measurements, macrophotographs and clinical

grading before and after 4w treatment phase

Questionnaire before, after 2 weeks and after 4weeks

treatment phase

TEWL measurements and clinical grading after 3 days and

6 days

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Methods Visual grading of dry skin by a clinician

The cutaneous state was examined by a trained clinician according to the Kligman’s scale. Kligman’s clinical scoring for dry skin is regarded as the standard for the visual clinical assessment used to diagnose the severity of dry skin. There are four gradations used to classify dry skin severity:

• Grade 1: normal skin, shows no visible signs of dryness and has a healthy shine and glow

• Grade 2: mild xerosis, characterised by small flakes and whitening of dermatoglyphic triangles (the lines that form patterns on the skin such as on the fingertips and palms of hands)

• Grade 3: moderate xerosis with small, dry flakes that cause a light, powdery appearance. Ccorners of the dermatoglyphic triangles start to uplift

• Grade 4: Well-defined xerosis, the entire length of a number of dermatoglyphic triangles have uplifted to generate large dry skin flakes, roughness is very evident

Grade 1 Grade 2

Grade 3 Grade 4

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Transepidermal water loss (TEWL), barrier integrity

The TEWL is defined as the measurement of the quantity of water that passes from inside the skin body through the epidermis to the surrounding atmosphere via diffusion and evaporation processes. Measurement of the TEWL is used for studying the water barrier function of the human skin and is expressed in grams per square meter and per hour. The more perfect the epidermal barrier, the lower the TEWL. The importance of TEWL as a measure of the skin barrier is well recognized.

Measurements of the TEWL were performed using Aquaflux® AF100 (Biox Systems Ltd., London, UK). The measurement chamber is a hollow cylinder whose lower end acts as a measurement orifice that is put into contact with the studied surface. Its upper end is sealed with an aluminium condenser that is maintained at the temperature of -7.6°C. When in contact with the studied surface, the measurement chamber is sealed and the air within it is protected from disturbance from ambient air movement.

The integrity of the epidermal barrier was challenged by 20 subsequent tape strippings. The strength of the barrier was evaluated by measuring the TEWL before and after the disruption.

Macrophotographic illustration

The studied skin areas were visualized with a digital video microscope (Hirox®, Hackensack, NJ, U.S.A.) using a mobile, fiber optic x20 lens being connected to an image acquisition computer system.

Self-evaluation by the subjects

The subjects filled in a questionnaire with structured scales (from 0 to 5) containing the following description of skin conditions:

Skin condition 0 → 5 Related to skin feeling:

My skin is dry not at all very much I feel tightness / discomfort not at all very much

I feel itching not at all very much

I feel stinging sensation not at all very much

My skin is robust not at all very much

Related to skin appearance: not at all very much

I recognize flakes / scales not at all very much

My skin is smooth not at all very much

My skin is soft not at all very much

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Results Dryness reduction (clinical grading according to Kligman)

After 4 weeks PENTAVITIN® reduces dry skin signs by 20%. The effects of PENTAVITIN® last for 72 hours after the last application.

0

5

10

15

20

25

after 4 week treatment 3 days after last treatment 6 days after last treatment

Impr

ovem

ent v

s. c

ontro

l [%

]

Strengthening of skin barrier function

PENTAVITIN® improves and strengthens skin barrier function, as shown by the 20% reduction in TEWL before and after 20 successive tape strippings after a four week application.

0

5

10

15

20

25

30

35

t0 t4w t0 t4w

TEW

L [g

/m2 /h

]

± SEM

Before tape stripping After 20 tape strippings

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Macrophotographs

PENTAVITIN® clearly improves the optical appearance of the skin. Scaling, the result of a disturbed desquamation, is normalized and light scattering is reduced leading to an increased light penetration into the deeper layers of the skin. Therefore the skin has become a more translucent appearance.

t0

4 weeks Volunteer 3 Volunteer 4

t0

4 weeks Volunteer 13 Volunteer 14

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Self evaluation by the subjects

The questionnaire confirms that PENTAVITIN® improves skin softness and smoothness by more than 50% and reduces skin flakiness and itchiness by more than 50% after a two week application.

0 10 20 30 40 50 60 70 80 90

Softness improvement

Smoothness improvement

Flakiness reduction

Skin robustness improvement

Stinging reduction

Itchiness reduction

Tightening reduction

Dryness reduction

% change

after 2 weeks application after 4 weeks application

Conclusion PENTAVITIN® improves dry skin signs evaluated by clinical gradings according to Kligman and retains the effects for at least 72h after the last application

PENTAVITIN® strengthens epidermal barrier function determined by measurements of transepidermal water loss of non and artificially damaged barrier

PENTAVITIN® impoves skin appearance evaluated by macrophotographs

PENTAVITIN® induces a improvement in the cutaneous state for "dry, soft and smooth skin", "tightness", “itchiness”, “stinging”, “robustness” and "visible flakes" evaluated by a subject questionnaire.

Comfortable skin feeling Skin feeling

Skin apearance