Permanent Epilation

DermaVista

Mechanism of ActionH.Ogel constitutes a real novelty in the cosmetological treatment of unwanted facial & body hair. The product is currently available in cream and in tubes of 75ml (face) & 150ml (body). The active ingredient "Sterolcomplex - BioAlpha" is a complex of plant sterols which achieves the inhibition of the activity of 5- alpha reductase, the enzyme responsible for the formation of dehydrotestosterone (DHT). It is proven that DHT is responsible for the development of unwanted hair. BioAlpha penetrates the stratum corneum and keeps testosterone from being converted into DHT. In addition it inhibits the aromatisation of testosterone into estadiol or androstendione into estrone, counterbalancing a possible preponderance of estrogens in the surrounding skin, that could make the skin more tender, loose and accumulate more lipids. Due to the high lipophility of BioAlpha, a capillary absorption is impossible and therefore, systemic effects can be excluded.

Chemistry

Chemistry

The growth of hair is divided in several parts of the hair cycle. Growing hair is said to be in the anagen phase. This phase is followed by the catagen phase which ends into the telogen phase. During anagen phase there is continuous production of hair. It lasts from several weeks (eyelashes) to several years (scalp hair). Before the catagen phase, hair growth comes to an end. During this phase the structures important for the growth of hair slowly regress. It lasts for several weeks. Then the hair remains in a silent phase, the telogen phase, which lasts for 3 to 4 months. These different phases are not synchronized; therefore there is constant growth and loss (after the telogen phase) of different hair. On the arms and legs only 20% of hairs are in the anagen phase. Epilation with wax is providing a strong stimulus for hair growth, since hair growth is more strongly triggered by plucking. After epilation with wax the hair cycle is synchronized. The hair providing a cosmetic problem is the so-called terminal hair, which arises from the villous hair, which is only hardly visible from distance.

Chemistry

Almost any living structure of hair is capable to chemically modify certain precursors of steroid hormones. The most important steroid for regulation of hair growth is dihydrotestosterone (DHT), which is formed from testosterone by the enzyme 5-alpha-reductase. There are two isoenzymes differing in the sensitivity towards chemical inhibitors. The sensitive type II is present in hair on the frontal scalp and the extremities whereas type I is predominant in pubic hair and in the hair of the axilla.

Chemistry

The quantitatively by far (concentration in the bloodstream 1000 fold higher than that of androstendione or testosterone in men and women) most predominant precursor is dehydroepiandrosteronesulfate (DHEAS). Of all the structures of the hair root only the sebaceous gland is capable to convert DHEAS into androstendione, which is the immediate precursor of testosterone, the hormone that is converted into the strong androgen DHT. Androstendione therefore has to diffuse from either the sebaceous gland or directly from the bloodstream into the other structures of the hair root in order to become reduced to testosterone and further reduced to DHT, since the other structures of hair such as dermal papilla and root sheets and probably also the bulge can convert testosterone into either DHT or androstendione.

H.Ogel

INCI for a cream: Aqua, Arlasolve DMI, -- Caprylic/Capric Triglyceride, Tribehenin, Sorbitan Laurate, Palmatine -- , Persea Gratissima (Avocado) Oil, Octyldodecanol, Tridecyl Salicylate, C12-13 Alkyl Lactate, Cetearyl Isononanoate, Coco-Glucoside - Aqua, Polyglyceryl-3 Methylglucose Distearate, Glycine Soja, Glycerin 99,5 %ig, Xylitol, Sorbitol, Ammonium Acryloyldimethyltaurate /VP Copolymer, Phenoxyethanol, Tocopheryl Acetate, Ethylhexylglycerin, Parfum Happy Hair, Serenoa Serrulata Fruit Extract, Capryloyl Glycine, Lactic Acid 80 % ig, -- Tocopherol, Ascorbyl Palmitate, Lecithin, Hydrogenated Palm Glycerides Citrate --, Ammonia - Aqua

Toxicological Study

Expression of the results

The cytotoxicity data obtained with the MTT assay is plotted against the concentrations, which generates dose-response curves.

The cytotoxicity curve/plot allows to determine: the theoretical regression curve the theoretical IC50 value (Inhibiting Concentration 50), i.e.

the concentration of test compound which inhibits cell growth/survival by 50%

The slope of the regression line: Y/X

The higher the IC50 the lower the cytotoxicity

The higher the slope - Y/X - the higher the cytotoxicity

Evaluation of tolerability and skin compatibility

DOSE mg/ml

Inhibition/Response of cell growth (in comparison with no treated cells)

5 86,2%

2,5 53,6%

1,25 46,1%

0,625 40,8%

0,3125 32,7%

0,156 13,2%

0,078 5%

0,039 0IC50 = 2.3 mg/ml

The IC50 value (Inhibiting Concentration 50) is the concentration of test compound which inhibits cell growth/survival by 50% . It makes it possible to evaluate the potential irritating effect.

IC50 < 0.5 shows a strong cytotoxic/irritating effect.

IC50 ≥0.5 ≤ 1.5 shows a moderate cytotoxic/irritating effect.

IC50 > 1.5 shows the absence of cytotoxic/irritating effects

ToxicologyMTT ASSAY

Cytotoxicity Assay on Cell Culturesy = 14,573x + 16,443

R2 = 0,8111

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6

Dosage (mg/ml)

Inh

ibit

ion

in

percen

tag

e

y = 36,416x + 34,554

R2 = 0,242

-100

-50

0

50

100

150

0 0,5 1 1,5 2 2,5

Dosage mg/ml

Inh

ibit

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in p

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H.Ogel

Summary of the data taken and evaluation of the potential irritating power of the tested product

The product called H.Ogel:

Has neither a cytotoxic effect nor a potential irritating effect at the concentrations (between 5 mg/ml and 0.039mg/ml) of the test compounds.

H.Ogel stimulates the regrowth of keratinocytes in vitro. Experimenter Dott.ssa Nadia LOSIOMonitor Dott.ssa Elena BOCCHIETTOQuality Control Dr. Claudio ANGELINETTA

Clinical Study

Clinical Study – H.Ogel

50 Subjects females between 18 and 50 years of ageMethod of application:The product was uniformly applied on specific body areas that had

been previously depilated with warm wax. Clinical Studies lasted six months. The product was applied following the doctors’ instructions reported in a form that was given to each volunteer.

Execution of the test:On recruiting volunteers as well as during monthly visits, our

dermatologists carried out a phototrichogram (hair count which takes into account hair thickness, colour and length) on a well-defined area. Checks were carried out after 30 days (T30), 60 days (T60), 90 days (T90), 120 days (T120), 150 days (T150) and 180 days (T180) - each time the day before epilation.

Hair number variations in time are evaluated according to the following clinical score

Hair number Value

No variation in hair number 0

Slight variation in hair number 2

Evident variation in hairnumber 4

Very evident variation innumber of hair which regrowsafter treatment

6

Summarizing table of the dataHair numberRif vol.

Dens ità dei peli

nell'area cons iderata

Hair number

Dens ità dei peli

nell'area cons iderata

Hair number

Dens ità dei peli

nell'area cons iderata

Hair number

Dens ità dei peli

nell'area cons iderata

Hair number

Dens ità dei peli

nell'area cons iderata

Hair number

Dens ità dei peli

nell'area cons iderata

Hair number

T3 0 T6 0 T9 0 T1 2 0 T1 5 0 T1 8 0

V0 1 0 2 2 4 4 6

V0 2 0 0 0 0 2 2

V0 3 2 2 2 2 4 4

V0 4 2 2 4 4 6 6

V0 5 2 4 6 6 6 6

V0 6 0 2 4 4 4 4

V0 7 0 4 4 4 6 6

V0 8 0 4 4 4 4 6

V0 9 0 0 2 2 4 4

V1 0 2 4 6 6 6 6

V1 1 2 4 6 6 6 6

V1 2 4 6 6 6 6 6

V1 3 2 4 4 4 4 4

V1 4 0 0 0 0 2 4

V1 5 6 6 6 6 6 6

V1 6 4 4 4 6 6 6

V1 7 0 2 4 6 6 6

V1 8 0 2 2 4 4 4

V1 9 2 4 6 6 6 6

V2 0 4 4 4 4 4 6

V2 1 0 0 0 2 2 2

V2 2 0 2 2 2 2 4

V2 3 4 4 6 6 6 6

V2 4 4 4 6 6 6 6

V2 5 0 4 6 6 6 6

V2 6 0 2 2 2 4 4

V2 7 0 2 2 2 2 4

V2 8 0 2 2 2 4 6

V2 9 0 2 2 4 4 4

V3 0 2 4 6 6 6 6

V3 1 2 4 4 6 6 6

V3 2 2 2 4 4 6 6

V3 3 2 2 4 4 4 6

V3 4 0 2 4 4 4 4

V3 5 2 2 4 4 4 4

V3 6 2 4 6 6 6 6

V3 7 0 0 6 4 6 6

V3 8 0 2 4 4 6 6

V3 9 0 0 0 2 2 4

V4 0 2 4 6 6 6 6

V4 1 2 4 6 4 4 4

V4 2 0 4 6 6 6 6

V4 3 4 4 6 4 4 4

V4 4 0 0 0 2 2 6

V4 5 2 4 4 6 6 6

V4 6 4 4 4 4 6 6

V4 7 0 2 4 4 6 6

V4 8 0 2 4 4 4 6

V4 9 4 4 6 4 4 4

V5 0 0 0 2 2 4 4

Media

Averag e1 ,4 2 ,7 2 3 ,8 8 4 ,1 2 4 ,6 8 5 ,1 6

Hair Number

0% 20% 40% 60% 80% 100%

T30

T60

T90

T120

T150

T180

No Variation Slight Evident Very evident

Hair Number

Hair numberEvident Very evident

No variation Slight variation variation in variation in

in hair number in hair number hair number hair number Total

N % N % N % N % NChecksT30 25 50% 16 32% 8 16% 1 2% 50T60 8 16% 18 36% 22 44% 2 4% 50T90 5 10% 10 20% 18 36% 17 34% 50T120 2 4% 10 20% 21 42% 17 34% 50T150 7 14% 19 38% 24 48% 50T180 2 4% 17 34% 31 62% 50

Hair re-growth variations in time are evaluated according to the following clinical score

Hair regrowth

Value

No variation 0

Hair re-grows a little bit finer 2

Hair re-grows finer 4

Hair re-grows finer and de-pigmented 6

Hair RegrowthRif vol.

Modalità di

ricompars a del pelo

How hair re-g row

Modalità di r icompars a

del pelo

How hair re-g row

Modalità di

ricompars a del pelo

How hair re-g row

Modalità di r icompars a

del pelo

How hair re-g row

Modalità di r icompars a

del pelo

How hair re-g row

Modalità di r icompars a

del pelo

How hair re-g row

T3 0 T6 0 T9 0 T1 2 0 T1 5 0 T1 8 0

V0 1 2 2 2 4 4 6

V0 2 2 2 2 4 4 4

V0 3 2 2 4 4 4 4

V0 4 2 4 6 4 6 6

V0 5 0 2 4 4 4 6

V0 6 0 2 4 4 4 4

V0 7 0 4 4 4 6 6

V0 8 4 4 4 6 6 6

V0 9 4 4 4 6 6 6

V1 0 2 4 6 4 4 6

V1 1 2 4 4 4 4 6

V1 2 4 6 6 6 6 6

V1 3 2 4 6 4 4 4

V1 4 2 2 2 4 6 6

V1 5 6 6 6 6 6 6

V1 6 6 6 6 6 6 6

V1 7 6 6 6 6 6 6

V1 8 2 2 2 4 4 4

V1 9 2 4 6 4 4 4

V2 0 4 6 6 6 6 6

V2 1 0 2 2 2 2 2

V2 2 0 2 2 2 2 4

V2 3 4 4 6 6 6 6

V2 4 4 4 6 6 6 6

V2 5 0 4 6 6 6 6

V2 6 0 2 4 4 4 4

V2 7 4 4 4 6 6 6

V2 8 0 4 4 4 4 6

V2 9 0 2 4 4 4 4

V3 0 6 6 6 6 6 6

V3 1 4 4 4 6 6 6

V3 2 2 4 4 4 6 6

V3 3 2 2 4 4 4 6

V3 4 4 4 4 4 4 4

V3 5 2 2 4 4 4 4

V3 6 2 4 6 6 6 6

V3 7 4 4 4 4 6 6

V3 8 2 4 4 4 6 6

V3 9 2 2 2 4 4 4

V4 0 2 4 4 6 6 6

V4 1 2 2 4 4 4 4

V4 2 0 4 6 6 6 6

V4 3 4 4 6 4 4 4

V4 4 2 2 2 4 4 6

V4 5 4 4 6 6 6 6

V4 6 4 4 4 4 6 6

V4 7 4 4 4 4 6 6

V4 8 0 4 4 4 4 6

V4 9 0 2 4 4 4 4

V5 0 4 4 4 4 4 4

Media

Averag e2 ,4 4 3 ,5 6 4 ,3 6 4 ,6 4 ,9 2 5 ,2 8

Hair Regrowth

0% 20% 40% 60% 80% 100%

T30

T60

T90

T120

T150

T180

finer and depigm. finer little bit finer No Variation

Hair Regrowth

Hair regrowthHair re-grow

a little bit Hair re-grow Hair re-grow finer

No variation finer finer and de pigmented Total

N % N % N % N % NChecksT30 12 24% 19 38% 15 30% 4 8% 50T60 17 34% 27 54% 6 12% 50T90 8 16% 25 50% 17 34% 50T120 2 4% 31 62% 17 34% 50T150 2 4% 23 46% 25 50% 50T180 1 2% 16 32% 33 66% 50

Variation of the (Typical After Depilation) Irritation withH.Ogel Application

Variation of irritation after the product’s application

Variation of irritation after the product’s application

Value

no variation

10

hardly perceptible variation

8

slight variation

6

evident variation

4 very evident variation

2

Variation of irritation after product’s application

RIF. VOL Volunteer ref.

Prima dell'uso Dopo l'usoV01 10 2V02 10 4V03 10 6V04 10 4V05 10 2V06 10 4V07 10 4V08 10 2V09 10 6V10 10 6V11 10 4V12 10 4V13 10 2V14 10 4V15 10 2V16 10 4V17 10 4V18 10 4V19 10 4V20 10 2V21 10 2V22 10 2V23 10 2V24 10 2V25 10 6

Variazione Arrossamento Variation of the reddening

01

PRESENZA

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VARIAZIONE

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40

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PRESENZA

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40

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VARIAZIONE

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VARIAZIONE

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40

1

Reduction of the (after depilation) irritation with H.Ogel application

Very Evident

Evident Variation

Slight Variation

No Variation

Conclusions

Clinical Study ConclusionsAs one can notice, the product called H.Ogel:

Can significantly reduce the number of hair and delay the hair re-growth during the period of its application.

Moreover, the product’s application prevents the typical after depilation sensations such as skin reddening, burning or hurt.

According to the obtained results the product H.Ogel has proved, on the volunteers who underwent this study, to have a:

“COSMETIC POWER OF DELAYING HAIR RE-GROWTH”

Experimenter Dr.ssa Evelyn FALCONI KLEINMonitor Prof. Fulvio MARZATICOQuality Control Dr. Claudio ANGELINETTA