Pigment clinical testing for potential allergic reactions first in history of permanent makeup

12 February 2005: Honolulu, Hawaii

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 intended 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.

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.

Conclusion: Kolorsource pigments proven hypoallergenic

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 the Kolorsource pigments and ingredients are hypoallergenic.

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Linda H. Dixon MD
Research and Development

"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 Dr. Dixon.

Dr. Charles Zwerling, MD, ophthalmologist and author of the textbook Micropigmentation: State of the Art, states "Kolorsource has created a gold standard by which all pigments will be measured in the future".

"This 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.