Patent Application: US-14061593-A

Abstract:
a vitamin k mixture is used in a topical application for the treatment of blood vessel disorders of the skin which include , but are not limited to , actinic and iatrogenic purpura , lentigines and other vascular problems of the skin and subcutaneous tissue . the formulation of the mixture includes a number of the following substances : vitamin k , 95 % ethyl alcohol sd40 , isopropyl alcohol 99 %, benzyl alcohol , lecithin granules , isopropyl palmitate nf , propyl paraben , methyl paraben , pluronic f - 127 nf , dowicil 200 and preserved water . the concentrations of the substituent compounds vary in the different formulations of the vitamin k cream .

Description:
the present invention provides a method of treatment of vascular disorders of the skin by using a vitamin k cream and a formula for the composition of the cream itself . the present invention comprises the use of vitamin k in the form of either vitamin k - 1 ( phytonadione ) or vitamin k - 2 in a topical formulation for the treatment of actinic and iatrogenic purpura among other disorders of the skin . the use of a topical vitamin k - 1 containing cream is effective in the treatment of actinic and iatrogenic purpura and lentigines , among other disorders of the skin . my composition containing 1 % vitamin k - 1 in a unique cream base system delivers vitamin k into the skin and appears to have an influence on the disappearance of extravascular blood , as well as decreasing the incidence of purpura , when compared to its base , when used on a twice daily basis . no benefit was obtained on the appearance of intact vessels of the skin when comparing the active to the placebo agent . there appears to be no effect on the vessel themselves , only on leaking vessels and blood already outside the dermal vascular system with this particular formulation and concentration . a preferred embodiment of the cream of the present invention comprises the compounding formula of a vitamin k - 1 cream - 5 %. to mix a 100 gram quantity of the vitamin k - 1 5 % cream , it is necessary to mix 5 grams of phytonadione ( roche vimmine and fine chemicals , hoffman - laroche inc ., belvidere , n . j . ), 5 ml of 95 % ethyl alcohol sd40 , 2 ml of benzyl alcohol ( carrubba , inc ., milford , conn . ), 10 grams of lecithin granules ( american lecithin co ., danbury , conn . ), 10 ml of isopropyl palmitate nf ( amerchol corp ., edison , n . j . ), and 20 grams pluronic f - 127 , nf ( basf corp ., parsippany , n . j .). the mixture is then qs &# 39 ; ed to 100 grams with preserved water . in the above preferred embodiment , pluronic f - 127 , nf is a known surfactant . a preferred embodiment of the cream of the present invention comprises the compounding formula of a vitamin k - 1 cream - 1 %. to mix a 100 gram quantity of the vitamin k - 1 cream - 1 %, it is necessary to mix 1 gram of phytonadione ( roche vitamine and fine chemical , hoffman - laroche inc ., belvidere , n . j . ), 2 . 42 . ml of 99 % isopropyl alcohol ( ruger chemical co ., irvington , n . j . ), 1 . 73 ml of benzyl alcohol ( carrubba , inc ., milford , conn . ), 8 . 26 grams of lecithin granules ( american lecithin co ., danbury , conn . ), 7 . 44 ml of isopropyl palmitate nf ( amerchol corp ., edison , n . j . ), and 16 . 53 grams pluronic f - 127 , jf ( basf corp ., parsippany , n . j . ), 0 . 04 gram propyl paraben ( ruger chemical corp ., irvington , n . j . ), 0 . 13 gram methyl paraben ( ruger chemical corp ., irvington , n . j . ), 0 . 04 gram dowicil 200 ( ruger chemical corp ., irvington , n . j .) and 62 . 41 ml distilled water . in the above preferred embodiment , pluronic f - 127 , nf is a known surfactant . case study of the treatment with vitamin k - 1 cream ( 0 . 8 % to 1 %) the initial study of the effects of a vitamin k - 1 cream used in treatment of blood vessel disorders of the skin and skin disorders caused by photoaging involved use of a cream of 0 . 8 % to 1 % concentration of vitamin k - 1 in june , 1993 on actinic and iatrogenic purpura among other skin disorders . twelve patients were selected to apply this medication twice daily and all noticeably benefited from its use . the twelve patients who were chosen to participate in the study had purpura on the hands and arms . patients for easy bruising were solicited by newspaper as well as from hematologists and rheumatologists . two creams were prepared , one with vitamin k - 1 ( 0 . 8 % to 1 % ) and one identical except with no vitamin k and added yellow color to make the agents appear the same . because of the size of the vitamin k molecule , it was necessary to develop a unique delivery system to ensure penetration . at the commencement of this study , patients were evaluated and photographed . informed consent was obtained from the patients . patients were instructed according to the following protocol : 1 . apply cream a to the back of the right hand and the lower arm with the left hand using an amount the size of a pea . 2 . apply cream b to the back of the left hand and the lower arm with the right hand using an amount the size of a pea . 3 . use no moisturizers , no glycolic acid , no retin a and no topical medications on the hands during the period of this study . 4 . return in 2 , 4 and 6 weeks for evaluation and further photographs . the additional 6 patients were entered into a separate protocol to determine the possibility of the topical agent decreasing the appearance of spider veins of the face according to the following protocol : 1 . apply cream a with the right hand to the right side of the face and cream b to the left side of the face with the left hand at bedtime on dry skin . 3 . use no retin a , glycolic acid or moisturizers during the study . within 4 weeks of application , all patients with actinic purpura and easy bruising had a decrease in the time required for healing on the active compound side compared to the opposite ( placebo ) side as well as a decreased appearance of lesions following trauma . no patients reported adverse effects of the active cream or the placebo - no itching , erythema , dryness , etc . two patients noticed a decrease in the lentigines on the active side versus the placebo side , which was also evident in the photographs . there was no difference in the spider veins of the face in any of the patients comparing the active to the placebo agent . the comparative results are shown in the attached drawings ( photographs ) where fig2 shows the effect of two days before treatment with 0 . 8 % to 1 % vitamin k - 1 cream in comparison to fig1 which shows iatrogenic purpura prior to treatment . fig3 and 6 show blood vessel disorders of the skin and disorders of the skin caused by photoaging before treatment . fig5 shows the effect of four weeks of treatment with 0 . 8 % to 1 % vitamin k - 1 cream on a patient &# 39 ; s right hand . in contrast , fig7 shows the effect on a patient &# 39 ; s left hand after four weeks of treatment with a placebo . a case study of the effects of a vitamin k - 1 cream - 5 % used in treatment of blood vessel disorders of the skin and skin disorders caused by photoaging involve the use of a vitamin k - 1 cream having a 5 % concentration of vitamin k - 1 on five patients . the patients exhibited blood vessel disorders on certain areas of the body . the disorders had been caused by either trauma , surgery or sun damage . two creams were prepared , one with vitamin k - 1 ( 5 %) and one identical except with no vitamin k and added yellow color to make the agents appear the same . because of the size of the vitamin k molecule , it was necessary to develop a unique delivery system to ensure penetration . at the commencement of this study , patients were evaluated and photographed . informed consent was obtained from the patients . patients were instructed according to the following protocol : 1 . apply cream a with the right hand to the right side of the face and cream b to the left side of the face with the left hand at bedtime on dry skin . 3 . use no retin a , glycolic acid or moisturizers during the study . three out of the five patients showed a decrease in the appearance of true blood vessels following application of the vitamin k - 1 cream - 5 %. in addition , the vitamin k - 1 cream - 5 % was applied to blood vessel disorders on the legs . however , no improvement of blood vessel disorders located on the legs were observed . while there have been described particular embodiments of the present invention of a new and useful formulation of and method of using a vitamin k cream in topical therapy for the treatment of blood vessel disorders of the skin , it is not intended that such references be construed as limitations upon the scope of this invention except as set for the in the following claims . further , although there have been described certain quantities and proportions used in the formulation of the preferred embodiments , it is not intended that such quantities and proportions be construed as limitations upon the scope of this invention except as set further in the following claims . guillamoont , sann et al . 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