First in the Nail Industry

Bio Sculpture has done thorough research on the effect that the product range has on clients and

technicians. Bio Sculpture is the first and to date the only nail company to submit their products to

extensive Clinical Research by an independent Research Company who is well known and re-

spected throughout the world.

Bio Sculpture is:

• The first to do a clinical research

• The largest cosmetic study ever done by Paraxel International Research

• The best ever results from a study done by Paraxel

Therefore Bio Sculpture was awarded a Five Star Safety Rating

Toxicology Report Conducted by SA Drug and Toxicology Information Trust

No animal studies were involved in the development or the toxicological evaluation of Bio Sculpture Prod-

ucts. Summary Quote in their own words: “We are of the opinion that this products, when applied under nor-mal or reasonable foreseeable conditions of use, poses virtually no risk for systemic toxicity, although it does

pose a limited risk for local skin reaction in sensitive users, which can be minimized by the correct usage. In

general, the toxicological profile of the ingredients of the products compares very favourably with that of

some other nail cosmetics on the market”

Clinical Research Report Conducted by Paraxel International

A study to assess the efficacy and tolerability of an UV light-cured gel (Bio Sculpture Gel).

Paraxel International Clinical Research Organization with 58 offices world wide, e.g. Australia, Canada, Denmark, Esto-

nia, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, Poland, Russia, Sweden, South Africa, UK

and USA, executed a clinical trail to assess the tolerability and efficacy of Bio Sculpture Nail Gel in first-time and previ-

ous long-term users. Twenty-five (25) sites participated in the trial and more than 500 volunteers were entered into the

study. Previous users as well as first time users were included to ensure that the data gathered over the 6-month evalua-

tion period comprised of not only volunteers that have been exposed to the period over a long period, but also those

with no previous exposure. Informative writing confirms that adverse effects such as nail fungus infections can be ex-

pected after a treatment period of 6-months, therefore the evaluation period was determined accordingly. Data for

the evaluation and statistical analysis were gathered with questionnaires as well as physical evaluations on three visits,

scheduled with 2-month intervals.

The study results were conclusive that Bio Sculpture Nail Gel is effective and tolerable. Participants were inter alia evalu-

ated for adverse effects of fungal infections of the nail and contact dermatitis of the fingers. Ninety-nine percent (99%)

of the first time users reported no fungal infection or contact dermatitis events. Furthermore, almost all long-term users

(99% and 98%) confirmed that no fungal infection or contact dermatitis events respectively, were experienced. The

result on occupational exposure proved that 99% of the nail technicians experienced no contact dermatitis.

Consequently, the conclusion is drawn that Bio Sculpture Nail Gel is rated not only highly effective

but also tolerable during and after occupational exposure and usage as a cosmetic nail gel.

Bio Sculpture Canada Inc. 1-877-4-BIO-GEL

Bio Sculpture Gel awarded Five Star Safety

Rating in Clinical Research

Quality, Quantitative and Qualitative Research Conducted by Dr. J.H. Breytenbach

A survey to assess the negative effects and causes thereof, of

Bio Sculpture products on Bio Sculpture nail technicians. (May 2004)

Summary:

It is clear that the group of Nail Technicians who indicated that they had a contact dermatitis reaction on

their hands, were more likely to report an allergy of some extent of the list of possibilities, e.g. food, eye

cream, sun block and animals. Nearly 25% were smokers, 17% had surgery during the previous12 months,

30% reported that their skins were sensitive to sunlight, 50% were on some form of medication, 27% suffered

from eczema and 57% lived in a climate with extreme temperatures and humidity while 60% indicated that

their skin was irritated by non-Bio Sculpture products they use. Approximately 15% of respondents were aller-

gic to some form of acrylates.

From the group of respondents who reported that the skin on their hands was ever irritated, 56% indicated

that their hands were irritated by non-Bio products they used and used latex gloves. They were also irritated

by fabric, grass, pollen and dust. 13% of this group was treated for stress.

The group of respondents who suffered from blisters, also suffered from eczema and skin sensitivity to

sunlight. This group was more likely to apply solvents by means of a spray and showed an allergy for acry-

lates, clothing such as lycra stockings, certain underwear and synthetic material.

The gel product is inert (inactive) in its cured state, therefore it is important that technicians take care to re-

move uncured product from their skin in order to limit or prevent reaction, irritation, allergies or contact der-

matitis

Bio Sculpture Canada Inc. 1-877-4-BIO-GEL