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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: JanyBlueEyes who wrote (1620)	4/1/1998 1:07:00 PM
From: JanyBlueEyes	Read Replies (1) \| Respond to 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.

To: JanyBlueEyes who wrote (1620)	4/1/1998 1:09:00 PM
From: JanyBlueEyes	Respond to of 5736

PHOTOTHERAPY This information is in regards to treating psoriasis (one of the diseases specified in the news release). From nih.gov : Phototherapy UV light from the sun stimulates production of vitamin D by the skin, which slows the overproduction of skin cells that causes scaling. Daily, short, nonburning exposure to sunlight clears or improves psoriasis in some people. Therefore, sunlight may be included among initial treatments for the disease. A more controlled artificial light treatment may be used in mild psoriasis (UVB phototherapy) or in more severe or extensive psoriasis (psoralen and ultraviolet A [PUVA] therapy). UVB Phototherapy - Artificial sources of UVB light are similar to sunlight. Some physicians will start with UVB treatments instead of topical agents. UVB phototherapy also is used to treat widespread psoriasis and lesions that resist topical treatment. This type of phototherapy is normally administered in a doctor's office by using a light panel or light box, although with a doctor's guidance, some patients can use UVB light boxes at home. UVB phototherapy also may be combined with other treatments.......... PUVA - This treatment combines oral or topical administration of a medicine called psoralen with exposure to ultraviolet A (UVA) light........PUVA is normally used when more than 10 percent of the body's skin is affected or when rapid clearing is required because the disease interferes with a person's occupation.......Compared with daily UVB treatment, PUVA treatment taken two to three times per week clears psoriasis more consistently but less quickly. However, it is associated with more side effects, including nausea, headache, fatigue, burning, and itching. Long-term treatment is associated with irregular skin pigmentation. Researchers have found that PUVA is effective and relatively safe when combined with some oral medications (retinoids and hydroxyurea) but appears to be associated with skin cancer when combined with other oral medications (for example, methotrexate or cyclosporine)...... From cam.org : UVB PHOTOTHERAPY Phototherapy: means the treatment of skin diseases, by ultraviolet rays coming either from the sun or artificial sources. Many diseases spontaneously improve or disappear during the summer months. Solar radiation reaching the earth contains 48% of visible light, 42% of infrared and 6% of ultraviolet rays, mainly UVA's & UVB's. The UVA's are 10 to 100 times more than the UVB's. This is mainly due to seasonal variations, the condition of the ozone layer, the latitude, the altitude, the clouds, the fog, the pollution and so on... Some diseases that would benefit from UVB phototherapy: Psoriasis vulgaris, eczema, folliculitis, furunculosis, pityriasis rosea, pityriasis licheno‹des chronica, parapsoriasis en plaques, mycosis fungoides, idiopathic pruritus, pruritus of renal failure, acne. UVB phototherapy could also be combined with other treatment modalities like: anthralin, steroid creams, calcipotriol, PUVA, retinoid, methotrexate and cyclosporin when indicated to control more severe types of psoriasis. Side effects of sunlight and UVB rays: -on the short run: redness, itching, dryness of the skin and inflammation of the cornea. -on the long run: the risk of photoaging, skin cancers and cataracts becomes elevated specially in skin types I & II. However, therapeutically effective doses of UVB radiation, given under careful supervision to treat psoriasis, are relatively safe and very effective.