Formulations for epidermal repair

Abstract

The present disclosure is directed to dermatological formulations and their use for treating a variety of dermatological diseases and disorders, and for repairing and restoring a disrupted epidermal barrier, inhibiting inflammation, restoring a proper environment for maintaining a balanced symbiotic microbiome, and inhibiting the growth of pathogenic microorganisms in the epidermis—the outer layer of mammalian skin.

1 . A composition comprising therapeutically effective amounts of at least one of each of the following:
 a ceramide;   a cholesterol/lanosterol ester; and   a very long chain fatty acid (VLCFA).   
     
     
         2 . The composition of  claim 1 , further comprising isostearyl isostearate. 
     
     
         3 . The composition of  claim 1 , further comprising a therapeutically effective amount of phytosphingosine. 
     
     
         4 . The composition of  claim 1 , further comprising an acidifying agent to maintain a pH of 4.6-5.6, wherein the acidifying agent comprises a polyhydroxy acid. 
     
     
         5 . The composition of  claim 1 , further comprising a calcium chelator, wherein the calcium chelator is ethylenediaminetetraacetic acid (EDTA) or phytic acid. 
     
     
         6 . The composition of  claim 1 , further comprising a therapeutically effective amount of nicotinamide. 
     
     
         7 . The composition of  claim 1 , further comprising a therapeutically effective amount of 18β-glycyrrhetinic acid, glycyrrhizic acid, carbenoxolone, chenodeoxycholic acid, or PF-877423, or combinations thereof. 
     
     
         8 . The composition of  claim 1 , further comprising a therapeutically effective amount of hydrocortisone, triamcinolone, clobetasol, betamethasone, fluticasone, or fluocinonide, or combinations thereof. 
     
     
         9 . The composition of  claim 1 , wherein the ceramide is chosen from at least one of Cer 1 [EOS], Cer 2 [NS], Cer 3 [NP], Cer 4 [EOH], Cer 5 [AS], Cer 6 [AP], Cer 7 [AH], Cer 8 [NH], and Cer 9 [EOP]. 
     
     
         10 . The composition of  claim 1 , wherein the cholesterol and/or lanosterol ester is chosen from at least one of cholesterol oleate, cholesterol laurate, cholesterol myristate, cholesterol palmitate, cholesterol stearate, cholesterol arachidate, cholesterol behenate, cholesterol lignocerate, cholesterol cerotate, cholesterol montanate, cholesterol melissate, lanosterol oleate, lanosterol laurate, lanosterol myristate, lanosterol palmitate, lanosterol stearate, lanosterol arachidate, lanosterol behenate, lanosterol lignocerate, lanosterol cerotate, lanosterol montanate, and lanosterol melissate. 
     
     
         11 . The composition of  claim 1 , wherein the VLCFA is chosen from at least one of lignoceric acid, cerotic acid, montanic acid, and melissic acid. 
     
     
         12 . The composition of  claim 1 , wherein the concentrations of ingredients, in percent weight per weight (w/w), if present, range as follows:
 ceramide, 0.0001-10% (w/w);   cholesterol and/or lanosterol ester, 0.0001-10% (w/w);   VLCFA, 0.01-10% (w/w);   phytosphingosine, 0.0001-10% (w/w);   isostearyl isostearate, 0.01-10% (w/w);   acidifying agent to maintain a pH of 4.6-5.6, X-Y % (w/w);   EDTA or phytic acid, 0.01-2.0% (w/w);   nicotinamide, when present, 0.01-10.0% (w/w),   18β-glycyrrhetinic acid, glycyrrhizic acid, carbenoxolone, chenodeoxycholic acid, or PF-877423, or combinations thereof, when present, 0.0001-5% (w/w),   hydrocortisone or an analog thereof, including, for example, the synthetic glucocorticoids kenelog/triamcinolone, clobetasol, betamethasone, fluticasone, fluocinonide, etc., or combinations thereof, when present, 0.001-10.0% (w/w), and   gluconolactone, when present, 0.01-8.0% (w/w).   
     
     
         13 . A composition comprising therapeutically effective amounts of:
 18β-glycyrrhetinic acid, glycyrrhizic acid, carbenoxolone, chenodeoxycholic acid, or PF-877423, or combinations thereof; and   hydrocortisone, triamcinolone, clobetasol, betamethasone, fluticasone, fluocinonide, or combinations thereof.   
     
     
         14 . The composition of  claim 13 , further comprising a therapeutically effective amount of
 a ceramide;   a cholesterol ester;   a VLCFA; and   isostearyl isostearate.   
     
     
         15 - 19 . (canceled) 
     
     
         20 . A method of treating, lessening the symptoms of, or preventing the symptoms of, a disease, disorder, or condition, the method comprising administering a therapeutically effective amount of a composition to the affected skin of a patient,
 wherein the composition comprises a ceramide, a cholesterol/lanosterol ester, and a very long chain fatty acid (VLCFA); and   wherein the disease, disorder, or condition is selected from:   a) Atopic and seborrheic dermatitis;   b) Eczematous dermatitis;   c) Ulcers and erosions due to cutaneous trauma;   d) Ichthyoses;   e) Epidermolysis bullosa;   f) Psoriasis and other papulosquamous disorders;   g) Cutaneous changes of intrinsic aging;   h) Mechanical friction blistering;   i) Corticosteroid atrophy;   j) Cutaneous lupus erythematosus;   k) Steroid-responsive dermatoses;   I) Rosacea;   m) Photodermatoses;   n) Symptoms of mycosis fungoides;   o) Acne;   p) Flushing of the skin; and   q) Keratosis Pilaris.   
     
     
         21 . The method of  claim 20 , wherein said patient is a human patient. 
     
     
         22 . The method of  claim 20 , wherein the composition is applied to the affected skin of a patient one or more times a day over a multiday period. 
     
     
         23 - 27 . (canceled) 
     
     
         28 . The method of  claim 20 , wherein the composition is administered to a premature infant under 33 weeks gestational age. 
     
     
         29 . The composition of  claim 1 , wherein the composition is effective to treat a disease, disorder, or condition of the skin. 
     
     
         30 . The composition of  claim 13 , wherein the composition is effective to treat a disease, disorder, or condition of the skin.