Spironolactone-containing composition and use thereof

Abstract

A composition containing spironolactone in an amount effective to suppress excess androgenic activity. The spironolactone-containing composition is applied directly to the skin site afflicted with excess androgens.

I claim: 
     
       1. A composition for effectively suppressing excess androgenic activity which occurs at a skin site so as to effectively treat .[.hirsuitisum.]. .Iadd.hirsutism, .Iaddend.said composition being .[.directly applied.]. .Iadd.in a form suitable for direct application .Iaddend.to said skin site .[., the composition.]. .Iadd.and .Iaddend.consisting essentially of .[.: a liquid carrier selected from the group consisting of alcohol, urea, mineral oil and white petrolatum; and .]. spironolactone in an amount of from about 0.25 wt. % to about 5.0 wt. %.Iadd., .Iaddend.which effectively suppresses excess androgenic activity at said skin site.Iadd., in a suitable carrier therefor; said composition having characteristics ranging from those of a cream to those of an ointment. .Iaddend. 
     
     
       2. The composition of claim 1 wherein .[.said liquid.]. .Iadd.the .Iaddend.carrier is white petrolatum. 
     
     
       3. The composition of claim 1 further consisting essentially of: a solubilizer selected from the group consisting of stearyl alcohol, cetyl alcohol or mixtures thereof, said solubilizer being present in an amount of from about 1.5 wt. % to about 3.0 wt. % so as to aid incorporation of said spironolactone into said carrier.   
     
     
       4. The composition of claim 3 further consisting essentially of a viscosifier in an amount sufficient to aid in emulsification of said solubilizer in said carrier. 
     
     
       5. The composition of claim 1 further consisting essentially of: a preservative selected from the group consisting of methylhydroxybenzoate, propylhyroxybenzoate, or mixtures thereof, said preservative being employed in an amount sufficient to extend the useful like of said composition.   
     
     
       6. In a process for treating at least one skin site characterized by excess androgenic activity so as to effectively suppress said excess androgenic activity, the improvement comprising: directly applying a spironolactone-containing composition to said at least one skin site, said composition consisting essentially of .[.a liquid carrier selected from the group consisting of alcohol, urea, mineral oil and white petroleum and.]. spironolactone in an amount of from about 0.25 wt. % to about 5.0 wt. % .Iadd.in a suitable carrier therefor, .Iaddend.which effectively suppresses androgenic activity at said skin site. 
     
     
       7. The process of claim 6 wherein said .[.liquid.]. carier is white petrolatum. 
     
     
       8. The process of claim 6 wherein said composition further consists essentially of a solubilizer selected from the group consisting of stearyl alcohol, cetyl alcohol or mixtures thereof, said solubilizer being present in an amount of from about 1.5 wt. % to about 3.0 wt. % so as to aid incorporation of said spironolactone into said carrier. 
     
     
       9. The process of claim 8 wherein said composition further consists essentially of a viscosifier in an amount sufficient to aid in emulsification of said solubilizer in said carrier. 
     
     
       10. The process of claim 6 wherein said composition further consists essentially of a preservative selected from the group consisting of methylhydroxybenzoate, propylhydroxybenzoate, or mixtures thereof, said preservative being employed in an amount sufficient to extend the useful life of said composition. .Iadd.11. The process according to claim 6 for the treatment of hirsutism caused by excess androgenic activity. .Iaddend. .Iadd.12. The process according to claim 6 for the treatment of acne caused by excess androgenic activity. .Iaddend.