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Clinical Research

Research

Bio Sculpture is the first, and to date, the only nail company to do Clinical Research on their product.

Bio Sculpture has done thorough research on the effect that the product range has on clients and technicians.
Knowing the good and positive results from the toxicology and clinical trial reports, technicians and clients should refrain from using the product if they experience any form of discomfort on their fingers or if any adverse reaction occurs. Bio Sculpture takes no responsibility for Allergies or Contact Dermatitis that may occur.


Clinical Research Report: Bio Sculpture Gel 2004 Safety Survey

PURPOSE

THEY SAY IT'S MORE EFFECTIVE TO SHOW THAN TO TELL
Bio Sculpture has done a scientific research study to assess the efficacy and tolerability of UV Light cured gel (Bio Sculpture) - 02 August 2004

Bio Sculpture Gel is to our knowledge the first UV cured nail gel that has undergone and passed this stringent test.


METHOD

Tested to the Highest Standards
A clinical trial was conducted to assess the tolerability and efficacy of Bio Sculpture® UV light-cured nail gel in first-time and long-term users.

Twenty-five (25) sites participated in the trial and more than 500 volunteers were entered into the study. The 6-month evaluation period comprised of not only volunteers that have been exposed to the product over a long period, but also those with no previous exposure. Generally if paronychia were to appear on any nail treated with a nail system it would take approximately 6 months to show, according to scientific data. Therefore, the evaluation period for Bio Sculpture Gel was adjusted accordingly for both first-time and long-term users to encompass the 6-month time period. Data for both the evaluation and statistical analysis were collected by means of questionnaires and physical examinations at bi-monthly intervals (three visits) for short term users. Participants were tested for paronychia and contact dermatitis. The research results showed that one hundred percent (100%) of first-time users, and ninety nine percent (99%) of long-term users, reported no paronychia or contact dermatitis.

FINDINGS

Five- Star Safety Rating - Tested to the Highest Standards

The research result showed that one hundred percent (100%) of first-time users, and ninety nine percent (99%) of long-term users, reported no paronychia or contact dermatitis. Consequently, the conclusion is drawn that Bio Sculpture® UV light-cured nail gel is both highly effective and tolerable for use as cosmetic nail gel.


ARTICLE

Article that appeared in the Dec/Jan 2005 Pharmaceutical & Cosmetic Review

UV-Light curable gel for nails

Bio Sculpture UV-light curable nail gel provides an almost instantaneous binding and curing of the nail gel-coat due to cross-linking of polymers induced by ultraviolet light. Once cured, it leaves the nail hard, yet flexible, with a natural glossy finish.

The product is odorless and fume-free and is thought to be the first color nail gel on the market. This innovative product from Clocolan, South Africa, is exported to some 20 countries.

One of the cosmetics industry's goals is labeling products as "hypoallergenic". Although the term may have considerable market value in promoting products to consumers, there is, according to the FDA, no such thing as a "non-allergenic” cosmetic (see www.cfsan.fda.gov). However, Bio Sculpture International's nail gel has been tested on 500 volunteers over a six month period by a pharmaceutical research organization and the research shows that neither first-time users, nor 99% of long-term users experience contact dermatitis. This is because Bio Sculpture nail gel is applied without the use of primers and bonders which minimizes allergic reactions.


TOXICOLOGY REPORT

By SA Drug & Toxicology Information
No animal studies were involved in the development or the toxicological evaluation of the Bio Sculpture Products.

Summary Quote: "We are of the opinion that this product, 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 toxicology profile of the ingredients of the product compares very favorably with that of some of the other nail cosmetic products on the market."