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Kolorsource? Pigments
Clinical Trials Prove Safe, Hypoallergenic
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.
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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 test product was applied five (5) times during a two month period to each of 105 participants enrolled in the study. No reactions to the test product were reported during any phases of the testing period.
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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