Compositions for the treatment of dermatological diseases and disorders

Abstract

The present disclosure is directed to topical dermatological formulations, dermatological cleansing compositions, and bathwater conditioners designed to acidify the skin, and their use for restoring epidermal acidity, restoring a the epidermal barrier, inhibiting inflammation, establishing an environment appropriate for maintaining a balanced symbiotic microbiome, and inhibiting the growth of pathogenic microorganisms in the epidermis—the outer layer of mammalian skin.

1 . A topical dermatological formulation, comprising therapeutically effective amounts of the following:
 at least one acidifying agent; and   at least one calcium complexing agent.   
     
     
         2 . The topical dermatological formulation of  claim 1 , wherein said acidifying agent comprises one or more of the following: C 1 -C 6  monocarboxylic acid, a C 2 -C 9  dicarboxylic acid, C 6 -C 9  tricarboxylic acid, a C 6 -C 8  hydroxy acid, a C 6 -C 8  polyhydroxy acid or its lactone, vinegar, and vinegar powder. 
     
     
         3 . The topical dermatological formulation of  claim 2 , wherein said acidifying agent is one or more of the following: acetic acid, glucono delta-lactone, vinegar, and powdered vinegar. 
     
     
         4 . The topical dermatological formulation of  claim 3 , wherein said calcium complexing agent is one or both of the following: EDTA and EGTA. 
     
     
         5 . The topical dermatological formulation of  claim 3 , wherein the pH of said dermatological formulation is between 4.2 and 6.0 
     
     
         6 . The topical dermatological formulation of  claim 3 , further comprising at least one gelling agent. 
     
     
         7 . The topical dermatological formulation of  claim 6 , wherein said gelling agent is one or more hydrophilic gelling agents selected from one or more of the general classes of carboxyvinyl polymers, natural gums, and clays. 
     
     
         8 . The topical dermatological formulation of  claim 7 , wherein said gelling agent is one or more natural gums composed of polysaccharides. 
     
     
         9 . The topical dermatological formulation of  claim 6 , wherein said gelling agent is one or more carbomers comprising a cross-linked homopolymer of acrylic acid. 
     
     
         10 . The topical dermatological formulation of  claim 3 , further comprising at least one preservative agent. 
     
     
         11 . The topical dermatological formulation of  claim 10 , wherein said preservative agent is a blend of 1,2-hexanediol and 1,2-octanediol. 
     
     
         12 . The topical dermatological formulation of  claim 3 , further comprising one or more of an osmolality adjusting agent, an oil, a stiffener, an emollient, an emulsifying agent, a humectant, a hydrophilic or lipophilic active agent, an antioxidant, a fragrance, a fillers, a UV screening agent, and a colorant. 
     
     
         13 . A method of treating a dermatological disease or disorder at least partially characterized by an abnormally high skin pH, comprising administering a therapeutically effective amount of the dermatological formulation of  claim 1  to the affected skin of a patient, wherein the disease or disorder is selected from:
 a) atopic dermatitis 
 b) intertrigo 
 c) webspace infections; 
 d) pitted keratolysis; 
 e) foul-smelling feet and axillae 
 f) erythrasma; 
 g)tinea corporis 
 h) tinea pedis; 
 i) ichthyosis; 
 j) psoriasis; 
 k) acne; 
 i) rosacea; 
 m) seborrhoeic dermatitis; 
 n) diaper dermatitis; 
 o) irritant contact dermatitis; 
 p) keratosis pilaris; and 
 q) xerosis. 
 
     
     
         14 . A dermatological cleanser, comprising therapeutically effective amounts of the following:
 at least one acidifying agent;   at least one calcium complexing agent; and   at least one synthetic detergent.   
     
     
         15 - 17 . (canceled) 
     
     
         18 . The dermatological cleanser of claim  16 , wherein the pH of said dermatological cleanser is between 4.2 and 6.0; 
     
     
         19 - 25 . (canceled) 
     
     
         26 . A method of treating a dermatological disease or disorder at least partially characterized by an abnormally high skin pH, comprising cleansing the affected skin of a patient with a therapeutically effective amount of the dermatological cleanser of  claim 14 , wherein the disease or disorder is selected from:
 a) atopic dermatitis   b) intertrigo   c) webspace infections;   d) pitted keratolysis;   e) foul-smelling feet and axillae   f) erythrasma;   g) tinea corporis   h) tinea pedis;   i) ichthyosis;   j) psoriasis;   k) acne;   I) rosacea;   m) seborrhoeic dermatitis;   n) diaper dermatitis;   o) irritant contact dermatitis;   p) keratosis pilaris; and   q) xerosis   
     
     
         27 . A bathwater conditioner, comprising therapeutically effective amounts of the following:
 at least one acidifying agent; and   at least one calcium complexing agent.   
     
     
         28 - 30 . (canceled) 
     
     
         31 . A method of treating a dermatological disease or disorder at least partially characterized by an abnormally high skin pH, comprising dissolving or diluting a therapeutically effective amount of the bathwater conditioner of  claim 27  in bathwater to make conditioned bathwater, and having a patient with the dermatological disease or disorder soak themselves in the conditioned bathwater, wherein the disease or disorder is selected from:
 a) atopic dermatitis 
 b) intertrigo 
 c) webspace infections; 
 d) pitted keratolysis; 
 e) foul-smelling feet and axillae 
 f) erythrasma; 
 g) tinea corporis 
 h) tinea pedis; 
 i) ichthyosis; 
 j) psoriasis; 
 k) acne; 
 I) rosacea; 
 m) seborrhoeic dermatitis; 
 n) diaper dermatitis; 
 o) irritant contact dermatitis; 
 p) keratosis pilaris; and 
 q) xerosis 
 
     
     
         32 . A kit comprising:
 a topical dermatological formulation as described in  claim 1 ; and   instructions for use of the kit to treat a dermatological condition.   
     
     
         33 . The kit of  claim 32 , further comprising a means for estimating or measuring the pH of skin before and after treatment with one or more components of the kit.