Demonstrable efficacy across or within patient populations

Abstract

The present invention provides methods for improving observed or determined efficacy by administration of agents to more severely diseased subjects, as contrasted with less severely diseased subjects. The present disclosure specifically demonstrates that, with respect to treatment of certain skin conditions, and particularly conditions associated with dysregulated and/or diseased skin cells, administration to more severely diseased subjects improves observed or determined efficacy.

1 . A method comprising steps of:
 a) determining the severity of hyperhidrosis in individual subjects by stratifying the subjects into two or more categories based on hyperhidrosis severity, so that a first category comprises subjects having severe hyperhidrosis relative to at least a second category that comprises subjects having hyperhidrosis who are not severely diseased; and   b) administering the treatment to subjects in the first category and not to subjects not in the first category, wherein the treatment comprises transdermal administration of botulinum toxin A;   wherein the treatment has been demonstrated to achieve a reduction of 25% or more in perspiration when administered to the subjects in the first category; and not to achieve said reduction when administered to subjects in the second category.   
     
     
         2 . The method of  claim 1 , wherein the hyperhidrosis in the subjects having severe hyperhidrosis is characterized by elevated frequency or severity of hyperhidrosis symptoms, and/or earlier onset of such symptoms, relative to the hyperhidrosis in the subjects who are not severely diseased. 
     
     
         3 .- 18 . (canceled) 
     
     
         19 . The method of  claim 1 , wherein the hyperhidrosis is categorized as palmar, axillary, plantar, facial, cranial, or general hyperhidrosis. 
     
     
         20 . The method of  claim 1 , wherein the subjects having severe hyperhidrosis have 200 mg gravimetric sweat production (GSP) or more; and wherein the subjects having hyperhidrosis who are not severely diseased have less than 200 mg gravimetric sweat production in five minutes. 
     
     
         21 . The method of  claim 1 , wherein the transdermal administration comprises topical administration. 
     
     
         22 . A method comprising steps of:
 administering a treatment to subjects suffering from severe hyperhidrosis, and not to subjects suffering from hyperhidrosis that is not severe,   wherein the treatment comprises transdermal administration of botulinum toxin A in a vehicle;   and further wherein the treatment has been demonstrated to achieve a more dramatic difference relative to a vehicle control in severe hyperhidrosis than in hyperhidrosis that is not severe,   wherein the more dramatic difference comprises a reduction of 15% or more in perspiration.   
     
     
         23 . The method of  claim 22 , wherein the hyperhidrosis is categorized as palmar, axillary, plantar, facial, cranial, or general hyperhidrosis. 
     
     
         24 . The method of  claim 22 , wherein the hyperhidrosis in the subjects having severe hyperhidrosis is characterized by elevated frequency or severity of hyperhidrosis symptoms, and/or earlier onset of such symptoms, relative to the hyperhidrosis in the subjects who are not severely diseased. 
     
     
         25 . The method of  claim 22 , wherein the subjects having severe hyperhidrosis have 200 mg gravimetric sweat production (GSP) or more; and wherein the subjects having hyperhidrosis who are not severely diseased have less than 200 mg gravimetric sweat production in five minutes. 
     
     
         26 . The method of  claim 22 , wherein the transdermal administration comprises topical administration.