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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 25.01

-16.0%

Nov 6 3:59 PM EST

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To: JanyBlueEyes who wrote (1620)	4/1/1998 1:07:00 PM
From: JanyBlueEyes	Read Replies (1) of 5736

Understanding The Dermatology Application News I broke down the news release into sections and put it into non-medical terms for clarity. Note: I do not have any medical training, etc., therefore, if there are any discrepancies, please let me know. This is my best shot at it. FYI: ============== From the press release: Chromatics Color Sciences, International Inc.(NASDAQ:CCSI - news) announced today that it has completed feasibility studies pending IRB approval to commence clinical trials... --- HHS REGULATIONS ON PROTECTING HUMAN SUBJECTS The Department of Health and Human Services has promulgated regulations for the protection of human research subjects, enforced through the creation of institutional review boards (IRBs) at each participating institution....... Institutional Review Boards Every institution receiving HHS funds for research involving human subjects must set up an IRB. The IRB must review all research that is subject to HHS regulation. In most institutions the IRB will conduct a preliminary review of all research involving human subjects, exempting projects that are not subject to HHS regulation from a full review as mandated by the statute. The institution must provide the staff, meeting space, and supplies necessary for the IRB to conduct its reviews and properly document its findings...... ============== From the press release: .....commence clinical trials.....determining the level of phototherapy treatment to be used in treating numerous skin disorders and diseases and the patient's tolerance to such phototherapy treatment by quantifying the amount of pigmentation and hence, photo-protection in the skin of patients. This dermatological application of the Company's proprietary technology and device would be for patients of all ages and would be used in determining dosages of ultraviolet light (phototherapy treatment) to treat patients for a variety of diseases including psoriasis, eczema, cutaneous T-cell lymphoma, vitiligo, and others. . --- The clinical trials will be conducted to determine how much phototherapy should be used to treat various skin disorders and diseases and the patient's tolerance to the treatment. This will be done by monitoring the color of the patients skin. The incremental changes of these color readings measured over time will help to determine the dosage of ultraviolet light (phototherapy treatment) to treat patients for a variety of diseases. ============== From the press release: The noninvasive measurement of the skin color by the Company's Colormate device will be tested and verified against minimal erythema dose-testing including the Fitzpatrick skin type test. --- The Fitzpatrick skin type test (and others) will be used to "check and verify" the results while performing the clinical trials.

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