Methods and compositions for treating cutaneous fungal infections

Abstract

The present invention relates to methods and compositions for the treatment of dermatophytic conditions such as tinea pedis. Such conditions can progress through multiple stages, such as fungal and bacterial stages, making effective treatment results difficult to achieve. The invention relates to a combined therapy effective for treatment of the condition that utilizes daily administration of a balanced combination of antifungals, antiperspirants and drying agents to achieve a beneficial therapeutic effect, irrespective of the stage of the disease upon commencement of the treatment.

I claim: 
     
         1 . An antibiotic-free composition effective in treating a dermatophytic infection, the composition comprising actives selected from a group of antifungals and a group of anti-sweating agents, the antibiotic-free composition comprising:
 a specific antifungal active from the group of antifungals being 0.5 to 2.0 wt. % of a specific antifungal, the specific antifungal being terbinafine, present in an amount sufficient to effectively treat the dermatophytic infection;   an anti-sweating active from the group of anti-sweating agents being 5.0 to 30.0 wt. % of an anti-sweating agent, the anti-sweating ageing being an aluminum compound; and   one or more excipients for topical application of the composition.   
     
     
         2 . The composition of  claim 1  wherein the aluminum compound is aluminum chloride. 
     
     
         3 . The composition of  claim 1  wherein the dermatophytic infection includes  Trichophyton rubrum  ( T. rubrum ). 
     
     
         4 . The composition of  claim 1  wherein the dermatophytic infection includes  T. rubrum.    
     
     
         5 . The composition of  claim 4  wherein the  T. rubrum  is consistent with ATCC MYA-4438. 
     
     
         6 . The composition of  claim 1  wherein the excipient is a liquid and the composition is in the form of a solution. 
     
     
         7 . The composition of  claim 6  wherein the excipient includes an alcohol. 
     
     
         8 . The composition of  claim 1  wherein the excipient includes at least one of a solvent, solid or semisolid carrier, diluent, bulking agent, propellant, foaming agent, film-forming agent, emollient, humectant, thickening agent, delivery enhancer, surfactant, buffering agent, stabilizer, preservative, absorbent, anti-static agent, fragrance, or colorant. 
     
     
         9 . A method for antibiotic-free treatment of a dermatophytic infection, comprising the steps of:
 topically applying a specific antifungal, the specific antifungal being terbinafine and present in an amount between 0.5 and 2 wt. %, the specific antifungal sufficient to effectively treat the dermatophytic infection;   topically applying an anti-sweating compound, the antisweating compound being 5.0 to 30.0 wt. % of an aluminum compound;   topically applying one or more excipients to assist the topical application,   wherein the specific antifungal, the anti-sweating compound and the one or more excipients are all applied during a single administration event,   such that an efficacious result can be achieved by only daily administrations.   
     
     
         10 . The composition of  claim 9  wherein the aluminum compound is aluminum chloride. 
     
     
         11 . The composition of  claim 9  wherein the dermatophytic infection includes  Trichophyton rubrum  ( T. rubrum ). 
     
     
         12 . The composition of  claim 9  wherein the dermatophytic infection includes  T. rubrum.    
     
     
         13 . The composition of  claim 12  wherein the  T. rubrum  is consistent with ATCC MYA-4438. 
     
     
         14 . The method of  claim 9  wherein the applying is in the form of a solution, a spray or a wipe. 
     
     
         15 . The method of  claim 9  wherein the applying results in a topical antifungal skin concentration of greater than or equal to the MIC of the antifungal. 
     
     
         16 . The method of  claim 15  where the topical antifungal skin concentration 24 hours after application is equal to or greater than the MIC of the antifungal. 
     
     
         17 . The method of  claim 9  wherein a duration of the treatment is between one and four weeks. 
     
     
         18 . A composition for treatment of a dermatophytic infection produced by the process of:
 adding a specific antifungal to an excipient to create a mixture, the specific antifungal being 0.5 to 2.0 wt. % terbinafine;   adding a measured amount of anti-sweating agent to the mixture, the anti-sweating agent being 5.0 to 30.0 wt. % aluminum compound;   adding additional excipient, if required, to establish a concentration of the specific antifungal agent sufficient to effectively treat the dermatophytic infection; and   establishing uniform dispersion of the specific antifungal, the anti-sweating compound and the excipient in the mixture by mixing, if necessary.   
     
     
         19 . The composition of  claim 18  wherein the aluminum compound is aluminum chloride. 
     
     
         20 . The composition of  claim 18  wherein the dermatophytic infection includes  Trichophyton rubrum  ( T. rubrum ). 
     
     
         21 . The composition of  claim 18  wherein the dermatophytic infection includes  T. rubrum.    
     
     
         22 . The composition of  claim 21  wherein the  T. rubrum  is consistent with ATCC MYA-4438. 
     
     
         23 . The composition of  claim 18  wherein the mixture is distributed on a wipe for treatment of a dermatophytic condition of a patient. 
     
     
         24 . The composition of  claim 18  wherein the excipient comprises an alcohol. 
     
     
         25 . A kit for the treatment of a dermatophytic condition comprising:
 an article, the article comprising:   an anti-sweating agent that includes 5.0 to 30.0 wt. % of an aluminum compound;   a specific antifungal of terbinafine present in an amount of between 0.5 and 2.0 wt. %, sufficient to effectively treat the dermatophytic infection,   one or more excipients for topical application of the composition, and   a storage container for housing the at least one article.   
     
     
         26 . The composition of  claim 25  wherein the aluminum compound is aluminum chloride. 
     
     
         27 . The composition of  claim 25  wherein the dermatophytic condition includes  Trichophyton rubrum  ( T. rubrum ). 
     
     
         28 . The composition of  claim 25  wherein the dermatophytic condition includes  T. rubrum.    
     
     
         29 . The composition of  claim 28  wherein the  T. rubrum  is consistent with ATCC MYA-4438. 
     
     
         30 . The kit of  claim 13 , the kit further comprising an applicator, the applicator including at least one of a wipe, push stick, spray or foam nozzle, aerosol container and nozzle, or roller ball.