Permanent Makeup Pigments by Kolorsource Found Safe, Hypoallergenic, in Groundbreaking Scientific Study by Independent Clinical Investigators. Promises Peace of Mind for Public and Professionals.
In an unprecedented step in the history of permanent makeup or traditional tattooing, Linda H. Dixon MD subjected all pigments and ingredients in Kolorsource brand pigments to clinical trials by an outside scientific testing facility in order to determine any possible skin sensitization potential of the products. The results support the claim that Kolorsource pigments and ingredients are hypoallergenic.
(PRWEB) February 18, 2005 -- Allergic contact dermatitis, also known as
sensitization or delayed hyper-sensitivity is a cell-mediated immunological
phenomenon involving antigen recognition in the epidermis and subsequent
sensitization of T-lymphocytes. In the Gell and coombs system, it is classified
as Type IV, analogous to tuberculin sensitivity.
In an unprecedented step
in the history of permanent makeup or traditional tattooing, Linda H. Dixon MD
subjected all pigments and ingredients in Kolorsource brand pigments to clinical
trials by an outside scientific testing facility in order to determine any
possible skin sensitization potential of the products. Seventeen (17) talc-free
pigments of both synthetic organic and inorganic origin were in the test
product. Not all pigments tested are contained in Kolorsource Brand pigments but
were included for testing purposes. Historically, tattoo pigments have been
known to be tested by experimenting on unsuspecting persons by manufacturers
with little understanding that pigments can cause a severe, even disfiguring
allergic reaction. Cosmetic pigments that contain talc can cause granuloma
formation after cosmetic tattoos as well, according to Charles S. Zwerling, MD,
Chairman of the Board of the American Academy of
Micropigmentation.
Kolorsource pigments have been used safely in
permanent makeup since 1996 and some in traditional tattooing since 1990. "We
were acting in an abundance of caution on behalf of clients, patients and
professionals when we made the decision to subject all of our colors to
scientific investigation," said Dr. Dixon. "Recent high-profile allergic
reactions to permanent makeup pigments have focused everyone's attention on
science and safety. Because the face is the canvas in permanent makeup, you
cannot hide disfiguring allergic reactions. The best plan is to prevent them and
this was the goal of our study," Dr. Dixon stated.
Subject
Selection
Criteria for Inclusion
A. Subjects over the age of eighteen
years
B. Male or female subjects of any skin type or race wherein skin
pigmentation does not interfere with taking readings of skin reactions.
C.
Subjects who are cooperative and have given written informed consent after
having been advised of the risks and nature of the study.
D. Subjects must be
in good health, free of any significant active skin pathology.
Criteria for
Exclusion
A. History of known sensitivity to cosmetics in general and in
particular to the types of products being tested
B. Pregnancy or attempting
same during study period
C. Lactation.
D. Use of medications within thirty
(30) days of induction, e.g. corticosteroids, antihistamines which may tend to
attenuate responses.
Informed Consent
All subjects execute an Informed
Consent. Said Consent contains information regarding the purpose of the study
and possible risks of participation. Additionally, subjects are given a list of
materials being tested. Said list is a general description of the product types;
it contains no information with respect to brand names, manufacturers or
distributors.
Testing Procedure
The product consisting of 17 pigments
in dispersal was tested on 105 participants enrolled in the study consisting of
both men and women ranging in age from 18 to 77. No reactions to the test
product was reported during any phase of the testing
period.
Conclusion
Under the conditions of this test, no evidence of
increased likelihood of sensitization to the test product was present, and no
alert level was issued.
These results support the claim that Kolorsource
pigments and ingredients are hypoallergenic.
"Tests results of
Kolorsource Pigments support a claim of hypoallergenic and dermatologist tested,
the first such testing done in the history of permanent makeup", according to
Linda H. Dixon,MD, Research and Development.
Dr. Charles Zwerling, MD,
ophthalmologist and author of the book Micropigmentation: State of the Art,
states "Kolorsource has created a gold standard by which all pigments will be
measured in the future".
"This (test) goes a long way to assure the
public and professionals that hypoallergenic pigments can be and should be used
in micropigmentation and cosmetic tattooing." continues Dixon.
Note: The
American Academy of Micropigmentation does not endorse any product but welcomes
scientific studies or product testing intended to ensure the safety and
protection of the public, the profession and professionals.
The clinical
testing of pigments used in permanent makeup makes history and offers enhanced
safety for public and professionals against allergic reactions. Both organic and
inorganic pigments were included in test as well as the dispersal agents.
Pigments tested from Kolorsource™.
Chief Investigator: Diplomat of
American Board of Internal Medicine. Consulting Dermatologist: Diplomat of the
American Boards of Internal Medicine and Pediatric and Adult
Dermatology
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Source : http://www.prweb.com/releases/2005/2/prweb209511.htm