Effective Sensitizing Dose of a Gelled Immunomodulating Topical Composition

Abstract

The present invention relates to compositions and methods of treating warts and other human papilloma virus (HPV) skin infections. The present invention relates to compositions and methods of treating skin cancer.

1 . A method of treating a disease or disorder associated with human papilloma virus infection in a human patient, the method comprising administering to a first site on the skin of a human patient a low sensitizing dose of an immunomodulating gel composition followed by a subsequent administration to a second site on the skin of said patient a challenge dose of said immunomodulating gel composition, wherein said composition comprises diphenylcyclopropenone (DPCP). 
     
     
         2 . The method of  claim 1 , wherein said disease or disorder associated with human papilloma virus infection is selected from the group consisting of common warts, plantar warts, inguinal warts, venereal warts, and any combination thereof. 
     
     
         3 . The method of  claim 1 , wherein said low sensitizing dose is in the range of about 0.4% DPCP to about 0.6% DPCP, and wherein said challenge dose is in the range of about 0.04% DPCP to about 0.1% DPCP. 
     
     
         4 . The method of  claim 1 , wherein said low sensitizing dose is about 0.4% DPCP, and wherein said challenge dose is about 0.04%. DPCP. 
     
     
         5 . The method of  claim 1 , wherein a subsequent challenge dose is administered to the skin of said patient daily. 
     
     
         6 . The method of  claim 1 , wherein a subsequent challenge dose is administered to the skin of said patient every other day. 
     
     
         7 . The method of  claim 1 , wherein a subsequent challenge dose is administered to the skin of said patient biweekly. 
     
     
         8 . The method of  claim 1 , wherein a subsequent challenge dose is administered to the skin of said patient weekly. 
     
     
         9 . The method of  claim 1 , wherein said immunomodulating gel composition further comprises a gel delivery system comprising: a) a first co-solvent comprising a non-ionic surfactant, b) a second co-solvent comprising an alcoholic ester, and c) a gelling agent. 
     
     
         10 . The method of  claim 9 , wherein said first co-solvent is selected from the group consisting of polyoxyethylene (20) monoleate, polyoxyethylene (20) sorbitan monooleate, palmitate and stearate, and wherein said second co-solvent is selected from the group consisting of isopropyl myristate and isopropyl palmitate, and wherein said gelling agent is polyoxyl 40 stearate. 
     
     
         11 . A method of treating cancer in a human patient, the method comprising administering to a first site on the skin of a human patient a low sensitizing dose of an immunomodulating gel composition followed by a subsequent administration to a second site on the skin of said patient a challenge dose of said immunomodulating gel composition, wherein said composition comprises diphenylcyclopropenone (DPCP). 
     
     
         12 . The method of  claim 11 , wherein said cancer is selected from the group consisting of melanoma, cutaneous melanoma, Merkel cell carcinoma, basal cell carcinoma and it's subtype basal cell nevus syndrome, squamous cell carcinoma and it's subtype Bowen's Disease, actinic keratosis, and cutaneous T cell lymphoma and it's subtype mycosis fungoides. 
     
     
         13 . The method of  claim 11 , wherein said low sensitizing dose is in the range of about 0.4% DPCP to about 0.6% DPCP, and wherein said challenge dose is in the range of about 0.04% DPCP to about 0.1% DPCP. 
     
     
         14 . The method of  claim 11 , wherein said low sensitizing dose is about 0.4% DPCP, and wherein said challenge dose is about 0.04% DPCP. 
     
     
         15 . The method of  claim 11 , wherein a subsequent challenge dose is administered to the skin of said patient daily. 
     
     
         16 . The method of  claim 11 , wherein a subsequent challenge dose is administered to the skin of said patient every other day. 
     
     
         17 . The method of  claim 11 , wherein a subsequent challenge dose is administered to the skin of said patient biweekly. 
     
     
         18 . The method of  claim 11 , wherein a subsequent challenge dose is administered to the skin of said patient weekly. 
     
     
         19 . The method of  claim 11 , wherein said immunomodulating gel composition further comprises a gel delivery system comprising a first co-solvent comprising a non-ionic surfactant, a second co-solvent comprising an alcoholic ester, and a gelling agent. 
     
     
         20 . The method of  claim 19 , wherein said first co-solvent is selected from the group consisting of polyoxyethylene (20) monoleate, polyoxyethylene (20) sorbitan monooleate, palmitate and stearate, and wherein said second co-solvent is selected from the group consisting of isopropyl myristate and isopropyl palmitate, and wherein said gelling agent is polyoxyl 40 stearate. 
     
     
         21 . A method of treating a disease or disorder associated with human papilloma virus infection in a human patient, the method comprising administering to the skin of a human patient a sensitizing dose of about 0.4% DPCP followed by a challenge dose of about 0.04% DPCP at 14 days and then weekly challenge doses of about 0.04% DPCP for at least 6 weeks. 
     
     
         22 . A method of treating a disease or disorder associated with human papilloma virus infection in a human patient, the method comprising administering to the skin of a human patient a sensitizing dose of about 0.4% DPCP followed by a challenge dose of about 0.04% DPCP at 14 days and then biweekly challenge does of about 0.04% DPCP for at least 6 weeks. 
     
     
         23 . A method of treating skin cancer in a human patient, the method comprising administering to the skin of a human patient a sensitizing dose of about 0.4% DPCP followed by a challenge dose of DPCP in the range of about 0.04% to about 0.1% at 14 days and then biweekly challenge doses of DPCP in the range of about 0.04% to about 0.1% for a sufficient amount of time. 
     
     
         24 . A method of treating skin cancer in a human patient, the method comprising administering to the skin of a human patient a sensitizing dose of about 0.4% DPCP followed by a challenge dose of about 0.04% DPCP at 14 days and then biweekly challenge doses of about 0.04% DPCP for a sufficient amount of time. 
     
     
         25 . A method of enhancing an immune response in a human patient, the method comprising administering to a first site on the skin of a human patient a low sensitizing dose of an immunomodulating gel composition followed by a subsequent administration to a second site on the skin of said patient a challenge dose of said immunomodulating gel composition, wherein said composition comprises diphenylcyclopropenone (DPCP).