Polyethylene Glycol Compositions for Controlling Relapse of Herpes Labialis, Herpes Genitalis, and Herpes Zoster

Abstract

The present invention pertains generally to the field of therapy, and more specifically to the field of therapy for herpes simplex and herpes zoster, and more particularly, to methods of reducing the rate of relapse, delaying relapse, and/or preventing relapse of herpes labialis (cold sores on the lips), herpes genitalis (genital herpes), and herpes zoster (shingles, zona), by topical administration of polyethylene glycol (PEG), or a composition comprising PEG.

1 . A method of reducing the rate of relapse, delaying relapse, and/or preventing relapse of herpes labialis, herpes genitalis, or herpes zoster in a patient, comprising topically administering a therapeutically effective amount of:
 polyethylene glycol or a composition comprising polyethylene glycol.   
     
     
         2 . A method according to  claim 1 , which is a method of reducing the rate of relapse of herpes labialis in a patient, comprising topically administering to said patient a therapeutically effective amount of: polyethylene glycol or a composition comprising polyethylene glycol. 
     
     
         3 . A method according to  claim 1 , which is a method of delaying relapse of herpes labialis in a patient, comprising topically administering to said patient a therapeutically effective amount of: polyethylene glycol or a composition comprising polyethylene glycol. 
     
     
         4 . A method according to  claim 1 , which is a method of preventing relapse of herpes labialis in a patient, comprising topically administering to said patient a therapeutically effective amount of: polyethylene glycol or a composition comprising polyethylene glycol. 
     
     
         5 . A method according to any one of  claims 1  to  4 , wherein the topical administration is to one or more sites exhibiting an active viral infection or to a site where there are no signs of an active infection but where active infection is known to occur or is expected to occur. 
     
     
         6 . A method according to any one of  claims 2  to  4 , wherein the topical administration is on and/or around the lips of said patient. 
     
     
         7 . A method according to any one of  claims 2  to  4 , wherein the topical administration is on at least a part of the lips and the surrounding facial skin <1 cm from the border of the lips of said patient. 
     
     
         8 . A method according to any one of  claims 2  to  4 , wherein the topical administration is on the whole of both lips of said patient. 
     
     
         9 . A method according to any one of  claims 2  to  4 , wherein the topical administration is on the whole of both lips and on the surrounding facial skin <1 cm from the border of the lips of said patient. 
     
     
         10 . A method according to any one of  claims 1  to  9 , wherein the topical administration is from once daily to five times daily. 
     
     
         11 . A method according to any one of  claims 1  to  9 , wherein the topical administration is from once daily to three times daily. 
     
     
         12 . A method according to any one of  claims 1  to  9 , wherein the topical administration is twice daily. 
     
     
         13 . A method according to any one of  claims 1  to  11 , wherein the method is performed for a duration of at least 4 weeks. 
     
     
         14 . A method according to any one of  claims 1  to  11 , wherein the method is performed for a duration of at least 8 weeks. 
     
     
         15 . A method according to any one of  claims 1  to  11 , wherein the method is performed for a duration of at least 3 months. 
     
     
         16 . A method according to any one of  claims 1  to  15 , wherein the polyethylene glycol has a weight average molecular weight (Mw) of from about 200 to about 20,000. 
     
     
         17 . A method according to any one of  claims 1  to  15 , wherein the polyethylene glycol is polyethylene glycol with a weight average molecular weight (Mw) of from about 200 to about 1,000; or polyethylene glycol with a weight average molecular weight (Mw) of from about 1,000 to about 15,000; or a mixture thereof. 
     
     
         18 . Polyethylene glycol for use in a method of reducing the rate of relapse, delaying relapse, and/or preventing relapse of herpes labialis, herpes genitalis, or herpes zoster by topical administration. 
     
     
         19 . Polyethylene glycol for use according to  claim 18 , for reducing the rate of relapse of herpes labialis by topical administration. 
     
     
         20 . Polyethylene glycol for use according to  claim 18 , for delaying relapse of herpes labialis by topical administration. 
     
     
         21 . Polyethylene glycol for use according to  claim 18 , for preventing relapse of herpes labialis by topical administration. 
     
     
         22 . Polyethylene glycol for use according to any one of  claims 18  to  21 , wherein the topical administration is to one or more sites exhibiting an active viral infection or to a site where there are no signs of an active infection but where active infection is known to occur or is expected to occur. 
     
     
         23 . Polyethylene glycol for use according to any one of  claims 18  to  21 , wherein the topical administration is on and/or around the lips of the patient to be treated. 
     
     
         24 . Polyethylene glycol for use according to any one of  claims 18  to  21 , wherein the topical administration is on at least a part of the lips and the surrounding facial skin <1 cm from the border of the lips of the patient to be treated. 
     
     
         25 . Polyethylene glycol for use according to any one of  claims 18  to  21 , wherein the topical administration is on the whole of both lips of the patient to be treated. 
     
     
         26 . Polyethylene glycol for use according to any one of  claims 18  to  21 , wherein the topical administration is on the whole of both lips and on the surrounding facial skin <1 cm from the border of the lips of the patient to be treated. 
     
     
         27 . Polyethylene glycol for use according to any one of  claims 18  to  26 , wherein the topical administration is from once daily to five times daily. 
     
     
         28 . Polyethylene glycol for use according to any one of  claims 18  to  26 , wherein the topical administration is from once daily to three times daily. 
     
     
         29 . Polyethylene glycol for use according to any one of  claims 18  to  26 , wherein the topical administration is twice daily. 
     
     
         30 . Polyethylene glycol for use according to any one of  claims 18  to  29 , wherein the administration period is at least 4 weeks. 
     
     
         31 . Polyethylene glycol for use according to any one of  claims 18  to  29 , wherein the administration period is at least 8 weeks. 
     
     
         32 . Polyethylene glycol for use according to any one of  claims 18  to  29 , wherein the administration period is at least 3 months. 
     
     
         33 . Polyethylene glycol for use according to any one of  claims 18  to  32 , wherein the polyethylene glycol has a weight average molecular weight (Mw) of from about 200 to about 20,000. 
     
     
         34 . Polyethylene glycol for use according to any one of  claims 18  to  32 , wherein the polyethylene glycol is polyethylene glycol with a weight average molecular weight (Mw) of from about 200 to about 1,000; or polyethylene glycol with a weight average molecular weight (Mw) of from about 1,000 to about 15,000; or a mixture thereof. 
     
     
         35 . Use of polyethylene glycol in the manufacture of a medicament for reducing the rate of relapse, delaying relapse, and/or preventing relapse of herpes labialis, herpes genitalis, or herpes zoster by topical administration. 
     
     
         36 . Use of polyethylene glycol, according to  claim 35 , in the manufacture of a medicament for reducing the rate of relapse of herpes labialis by topical administration. 
     
     
         37 . Use of polyethylene glycol, according to  claim 35 , in the manufacture of a medicament for delaying relapse of herpes labialis by topical administration. 
     
     
         38 . Use of polyethylene glycol, according to  claim 35 , in the manufacture of a medicament for preventing relapse of herpes labialis by topical administration. 
     
     
         39 . Use of polyethylene glycol, according to any one of  claims 35  to  38 , wherein the topical administration is to one or more sites exhibiting an active viral infection or to a site where there are no signs of an active infection but where active infection is known to occur or is expected to occur. 
     
     
         40 . Use of polyethylene glycol, according to any one of  claims 35  to  38 , wherein the topical administration is on and/or around the lips of the patient to treated. 
     
     
         41 . Use of polyethylene glycol, according to any one of  claims 35  to  38 , wherein the topical administration is on at least a part of the lips and the surrounding facial skin <1 cm from the border of the lips of the patient to be treated. 
     
     
         42 . Use of polyethylene glycol, according to any one of  claims 35  to  38 , wherein the topical administration is on the whole of both lips of the patient to be treated. 
     
     
         43 . Use of polyethylene glycol, according to any one of  claims 35  to  38 , wherein the topical administration is on the whole of both lips and the surrounding facial skin <1 cm from the border of the lips of the patient to be treated. 
     
     
         44 . Use of polyethylene glycol, according to any one of  claims 35  to  43 , wherein the topical administration is from once daily to five times daily. 
     
     
         45 . Use of polyethylene glycol, according to any one of  claims 35  to  43 , wherein the topical administration is from once daily to three times daily. 
     
     
         46 . Use of polyethylene glycol, according to any one of  claims 35  to  43 , wherein the topical administration is twice daily. 
     
     
         47 . Use of polyethylene glycol, according to any one of  claims 35  to  46 , wherein the administration period is at least 4 weeks. 
     
     
         48 . Use of polyethylene glycol, according to any one of  claims 35  to  46 , wherein the administration period is at least 8 weeks. 
     
     
         49 . Use of polyethylene glycol, according to any one of  claims 35  to  46 , wherein the administration period is at least 3 months. 
     
     
         50 . Use of polyethylene glycol, according to any one of  claims 35  to  49 , wherein the polyethylene glycol has a weight average molecular weight (Mw) of from about 200 to about 20,000. 
     
     
         51 . Use of polyethylene glycol, according to any one of  claims 35  to  49 , wherein the polyethylene glycol is polyethylene glycol with a weight average molecular weight (Mw) of from about 200 to about 1,000; or polyethylene glycol with a weight average molecular weight (Mw) of from about 1,000 to about 15,000; or a mixture thereof. 
     
     
         52 . A formulation suitable for topical administration comprising polyethylene glycol. 
     
     
         53 . A formulation according to  claim 52 , suitable for topical administration on and/or around the lips of a human patient. 
     
     
         54 . A formulation according to  claim 52  or  53 , wherein the polyethylene glycol has a weight average molecular weight (Mw) of from about 200 to about 20,000. 
     
     
         55 . A formulation according to  claim 52  or  53 , wherein the polyethylene glycol is polyethylene glycol with a weight average molecular weight (Mw) of from about 200 to about 1,000; or polyethylene glycol with a weight average molecular weight (Mw) of from about 1,000 to about 15,000; or a mixture thereof. 
     
     
         56 . A formulation according to any one of  claims 52  to  55 , wherein formulation contains at least 50% PEG by weight of the overall formulation. 
     
     
         57 . A formulation according to any one of  claims 52  to  55 , wherein formulation contains at least 95% PEG by weight of the overall formulation. 
     
     
         58 . A formulation according to any one of  claims 52  to  57 , in the form of an emulsion, a gel, an ointment, a cream, a balm, a stick, a facemask, a spray, a wipe, or a patch.