Pharmaceutical preparation useful for treating tumors and lesions of the skin and the mucous membranes and methods and kits using same

Abstract

A pharmaceutical preparation useful for treating a skin or mucous membrane lesion is provided. The pharmaceutical preparation including, as active ingredients, a therapeutically effective amount of trichloroacetic acid and hydrochloric acid, or trichloroacetic acid and formic acid or all three of these acids and optionally a crosslinking/fixating/preserving agent. Additional preparations are also described.

What is claimed is:  
     
         1 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion comprising, as active ingredients, therapeutically effective amounts of at least two active ingredients selected from the group consisting of trichloroacetic acid, hydrochloric acid and formic acid.  
     
     
         2 . The pharmaceutical preparation of  claim 1 , wherein a concentration of said trichloroacetic acid said hydrochloric acid and said formic acid is selected such that application of the preparation to the skin or mucous membrane lesion leads to drying and separation of the skin or mucous membrane lesion from a base tissue thereof.  
     
     
         3 . The pharmaceutical preparation of  claim 1 , wherein a concentration of trichloroacetic acid, said hydrochloric acid and said formic acid is selected such that application of the pharmaceutical preparation to the skin or mucous membrane lesion preserves a morphology of tissue thereof thereby enabling histopathological analysis of said tissue.  
     
     
         4 . The pharmaceutical preparation of  claim 1 , wherein a concentration of said trichloroacetic acid is selected from a range of 5% to 97% (w/w), said concentration of said hydrochloric acid is selected from a range of 3% to 38% (w/w) and said concentration of said formic acid is selected from a range 0.1% to 85% (w/w).  
     
     
         5 . The pharmaceutical preparation of  claim 1 , further comprising at least one crosslinking/fixating/preserving agent.  
     
     
         6 . The pharmaceutical preparation of  claim 5 , wherein said at least one crosslinking/fixating/preserving agent is selected from the group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         7 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion comprising, as active ingredients, about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         8 . The pharmaceutical preparation of  claim 7 , further comprising about 4% formaldehyde.  
     
     
         9 . The pharmaceutical preparation of  claim 1 , further comprising at least one agent selected from the group consisting of cytotoxic drugs, anti acne drugs, corticosteroids, anti-inflammatory agents, antibiotics, anti-viral agents, anti-psoriatic agents, keratinolytic agents, skin penetration enhancers, local anaesthetic agents, antiseptic agents metal ions, tars and urea.  
     
     
         10 . An ampoule containing the pharmaceutical preparation of claiml.  
     
     
         11 . An ampoule containing the pharmaceutical preparation of  claim 7 .  
     
     
         12 . A kit containing the pharmaceutical preparation of  claim 8 , the kit including at least two ampoules.  
     
     
         13 . An article-of-manufacturing comprising packaging material and a pharmaceutical preparation being identified for treatment of skin or mucous membrane lesions, said pharmaceutical preparation including, as active ingredients, therapeutically effective amounts of at least two agents selected from the group consisting of trichloroacetic acid, hydrochloric acid and formic acid.  
     
     
         14 . An article-of-manufacturing comprising packaging material and a pharmaceutical preparation being identified for treatment of skin or mucous membrane lesions, said pharmaceutical preparation including, as active ingredients, about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         15 . The article-of-manufacturing of  claim 13 , wherein said pharmaceutical preparation further comprises at least one crosslinking/fixating/preserving agent.  
     
     
         16 . The pharmaceutical preparation of  claim 15 , wherein the at least one crosslinking/fixating/preserving agent is selected from the group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         17 . The pharmaceutical preparation of  claim 14 , further comprising 4% (w/w) formaldehyde.  
     
     
         18 . A method of treating a skin or mucous membrane lesion, the method comprising applying to the skin or mucous membrane lesion a pharmaceutical preparation including, as active ingredients, a therapeutically effective amount of at least two agents selected from the group consisting of trichloroacetic acid, hydrochloric acid and formic acid.  
     
     
         19 . The method of  claim 18 , wherein a concentration of said trichloroacetic acid is selected from a range of 5% to 97% (w/w), said concentration of said hydrochloric acid is selected from a range of 3% to 38% (w/w) and said concentration of said formic acid is selected from a range of 0.1% to 85% (w/w).  
     
     
         20 . The method of  claim 18 , wherein said pharmaceutical preparation includes, as active ingredients, about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         21 . The method of  claim 18 , wherein said pharmaceutical preparation further includes at least one crosslinking/fixating/preserving agent selected from group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         22 . The method of  claim 20 , wherein the pharmaceutical preparation further comprises 4% (w/w) formaldehyde.  
     
     
         23 . The method of  claim 18 , further comprising repeating said applying to the skin or mucous membrane lesion said pharmaceutical preparation at predetermined time intervals.  
     
     
         24 . A method of treating and biopsying a skin or mucous membrane lesion, the method comprising: 
 (a) applying to the skin or mucous membrane lesion at least one mummifying preparation, so as to obtain, following a mummification period, a mummified skin or mucous membrane lesion; and    (b) collecting said mummified skin or mucous membrane lesion.    
     
     
         25 . The method of  claim 24 , wherein said mummifying preparation includes, as active ingredients, therapeutically effective amounts of at least two agents selected from the group consisting of trichloroacetic acid, hydrochloric acid and formic acid.  
     
     
         26 . The method of  claim 25 , wherein a concentration of said trichloroacetic acid is selected from a range of 5% to 97% (w/w), said concentration of said hydrochloric acid is selected from a range of 3% to 38% (w/w) and said concentration of said formic acid is selected from a range of 0.1% to 85% (w/w).  
     
     
         27 . The method of  claim 24 , wherein said mummifying preparation includes about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         28 . The method of  claim 24 , wherein said mummifying preparation further includes at least one crosslinking/fixating/preserving agent selected from group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quartemium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         29 . The method of  claim 27 , wherein said mummifying preparation further includes 4% (w/w) formaldehyde.  
     
     
         30 . The method of  claim 24 , further comprising repeating step (a) at predetermined time intervals.  
     
     
         31 . A method of treating, biopsying and histopathologically examining a skin or mucous membrane lesion, the method comprising: 
 (a) applying to the skin or mucous membrane lesion at least one mummifying preparation, so as to obtain, following a mummification period, a mummified skin or mucous membrane lesion;    (b) collecting said mummified skin or mucous membrane lesion;    (c) rehydrating said mummified skin or mucous membrane lesion;    and    (d) histopathologically examining said mummified skin or mucous membrane lesion.    
     
     
         32 . The method of  claim 31 , wherein said mummifying preparation includes, as active ingredients, a therapeutically effective amount of at least two active ingredients selected from the group consisting of trichloroacetic acid, hydrochloric acid and formic acid.  
     
     
         33 . The method of  claim 31 , wherein a concentration of said trichloroacetic acid is selected from a range of 5% to 97% (w/w), said concentration of said hydrochloric acid is selected from a range of 3% to 38% (w/w) and said concentration of said formic acid is selected from a range of 0.1% to 85% (w/w).  
     
     
         34 . The method of  claim 31 , wherein said mummifying preparation further comprises at least one crosslinking/fixating/preserving agent.  
     
     
         35 . The method of  claim 34 , wherein said at least one crosslinking/fixating/preserving agent is selected from group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1 ,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         36 . The method of  claim 31 , wherein said mummifying preparation includes about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         37 . The method of  claim 36 , wherein said mummifying preparation further includes 4% (w/w) formaldehyde.  
     
     
         38 . The method of  claim 31 , further comprising staining said mummified skin or mucous membrane lesion prior to (d).  
     
     
         39 . A kit useful for treating a skin or mucous membrane lesion comprising: 
 (a) an applicator including a reservoir configured for storing a pharmaceutical preparation, said reservoir being capped at one end by a removable applicator tip;    (b) a mechanism for forcing a pharmaceutical preparation stored by said reservoir through said applicator tip; and    (c) a plurality of applicator tips, each being sized and configured for applying said pharmaceutical preparation stored by said reservoir to a specific type, shape or size of a skin or mucous membrane lesion.    
     
     
         40 . The kit of  claim 39 , further comprising at least one ampoule containing a pharmaceutical preparation including, as active ingredients, a therapeutically effective amount of at least two agents selected from the group consisting of trichloroacetic acid, hydrochloric acid, and formic acid.  
     
     
         41 . The kit of  claim 39 , wherein a concentration of said trichloroacetic acid is selected from a range of 5% to 97% (w/w), said concentration of said hydrochloric acid is selected from a range of 3% to 38% (w/w) and said concentration of said formic acid is selected of 0.1% to 85% (w/w).  
     
     
         42 . The kit of  claim 39 , further comprising at least one ampoule containing a pharmaceutical preparation including about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         43 . The kit of  claim 39 , wherein the pharmaceutical preparation further comprises at least one crosslinking/fixating/preserving agent selected from group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         44 . The kit of  claim 42 , wherein the pharmaceutical preparation further includes 4% (wa/w) formaldehyde.  
     
     
         45 . An adhesive bandage useful for treating skin lesions comprising: 
 (a) an applicator pad containing a pharmaceutical preparation including at least two active ingredients selected from the group consisting of trichloroacetic acid, hydrochloric acid and formic acid; and    (b) an adhesive tape attached to said applicator pad, said adhesive tape being configured for attaching to a skin region so as to position said applicator pad against a portion of said skin region including a skin lesion thereby applying said pharmaceutical preparation to said skin lesion.    
     
     
         46 . The adhesive bandage of  claim 45 , wherein a concentration of said trichloroacetic acid is selected from a range of 5% to 97% (w/w), said concentration of said hydrochloric acid is selected from a range of 3% to 38% (w/w) and said concentration of said formic acid is selected from a range of 0.1% to 85% (w/w).  
     
     
         47 . The adhesive bandage of  claim 45 , wherein the pharmaceutical preparation further includes at least one crosslinking/fixating/preserving agent selected from the group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         48 . The adhesive bandage of  claim 45 , wherein the pharmaceutical preparation includes about 48% (w/w) trichloroacetic acid, about 8% (w/w) hydrochloric acid and about 3% (w/w) formic acid.  
     
     
         49 . The adhesive bandage of  claim 48 , wherein the pharmaceutical preparation further includes about 4% (w/w) formaldehyde.  
     
     
         50 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion comprising, as active ingredients, therapeutically effective amounts of at least two agents selected from the group consisting of trichloroacetic acid, hydrochloric acid, formic acid, monochloroacetic acid, dichloroacetic acid, glycolic acid, citric acid, kojic acid, acetic acid, azelaic acid, phosphoric acid, thioglycolic acid, salicylic acid and their salts and phenol.  
     
     
         51 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion comprising, as active ingredients, therapeutically effective amounts of at least one agent selected from the group consisting of trichloroacetic acid, hydrochloric acid, formic acid, monochloroacetic acid, dichloroacetic acid, glycolic acid, citric acid, kojic acid, acetic acid, azelaic acid, phosphoric acid, thioglycolic acid, salicylic acid and their salts and phenol and at least one crosslinking/fixating/preserving agent.  
     
     
         52 . The pharmaceutical preparation of  claim 51 , wherein said at least one crosslinking/fixating/preserving agent is selected from the group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         53 . The pharmaceutical preparation of  claim 52 , wherein a concentration of said formaldehyde is selected from a range of 0.01% to 0.1%.  
     
     
         54 . The pharmaceutical preparation of  claim 52 , wherein a concentration of said formaldehyde is selected from a range of 0.1% to 1%.  
     
     
         55 . The pharmaceutical preparation of  claim 52 , wherein a concentration of said formaldehyde is selected from a range of 1% to 10%.  
     
     
         56 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion, comprising, as active ingredients, therapeutically effective amounts of at least one agent selected from the group consisting of trichloroacetic acid, hydrochloric acid, formic acid, monochloroacetic acid, dichloroacetic acid, glycolic acid, citric acid, kojic acid, acetic acid, azelaic acid, phosphoric acid, thioglycolic acid, salicylic acid and their salts and phenol, and at least one nonoxidizing organic or inorganic acid.  
     
     
         57 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion, comprising at least one nonoxidizing organic or inorganic acid and at least one crosslinking/fixating/preserving agent, selected from the group consisting of formaldehyde, paraformaldehyde, glutaraldehyde, glyoxal, carbodi-imide, a formaldehyde donor, sodium hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea, dimethilol-5,5-dimethilhydantoin, dimethilol urea, 2-bromo-2-nitropropane 1,3-diol, quarternium-15, parabens, 5-chloro-2 methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane, ethanol and other alcohols and polyol.  
     
     
         58 . The pharmaceutical preparation of  claim 57 , wherein a concentration of said formaldehyde is selected from a range of 0.01% to 0.1%.  
     
     
         59 . The pharmaceutical preparation of  claim 57 , wherein a concentration of said formaldehyde is selected from a range of 0.1% to 1%.  
     
     
         60 . The pharmaceutical preparation of  claim 57 , wherein a concentration of said formaldehyde is selected from a range of 1% to 10%.  
     
     
         61 . A pharmaceutical preparation useful for treating a skin or mucous membrane lesion, comprising, as active ingredients, therapeutically effective amounts of at least one agent selected from the group consisting of trichloroacetic acid, hydrochloric acid, formic acid, monochloroacetic acid, dichloroacetic acid, glycolic acid, citric acid, kojic acid, acetic acid, azelaic acid, phosphoric acid, thioglycolic acid, salicylic acid and their salts and phenol, and at least one agent selected from the group consisting of cytotoxic drugs, anti acne drugs, corticosteroids, anti-inflammatory agents, antibiotics, anti-viral agents, anti-psoriatic agents, keratinolytic agents, skin penetration enhancers, local anaesthetic agents, antiseptic agents metal ions, tars and urea.