Bio Sculpture Canada Inc.

Bio Sculpture Gel awarded Five Star Safety
Rating in Clinical Research
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 respected 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 Products. Summary Quote in their own words: “We are of the opinion that this products, when applied under normal 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, Estonia, 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 previous 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 evaluation 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 expected 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 evaluated 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
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 allergic 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 acrylates, 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 remove uncured product from their skin in order to limit or prevent reaction, irritation, allergies or contact dermatitis
Bio Sculpture Canada Inc.
1-877-4-BIO-GEL