Method and system for enhancing self-treatment of onychomycosis

• US 20080153122A1
• Filed: 12/21/2006
• Published: 06/26/2008
• Est. Priority Date: 12/21/2006
• Status: Abandoned Application

• Current Assignee: Schering-Plough Healthcare Products Incorporated (Merck & Co., Inc.)
• Original Assignee: Schering-Plough Healthcare Products Incorporated (Merck & Co., Inc.)
• Inventors: Frank, Doreen, Morgan, Jay Philip, Nowak, Robert T., Cantor, Susan Beth, Goldberg, Glenn, Neumann, R. Stephen
• Application Number:
  US11/644,434
• Publication Number:
  US 20080153122A1
• Time in Patent Office: Days
• US Class Current: 435/29
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: G01N 33/56961 Plant cells or fungi

Abstract

Methods, systems, and devices for medical therapy compliance for the treatment of onychomycosis with a topically applied antifungal agent.

Claims

1. An article of manufacture, comprising:

a pharmaceutical composition for topical application comprising at least one antifungal agent;

indicia for self diagnosis of onychomycosis;

a nail growth monitoring device;

coordinating instructions for application of said pharmaceutical composition in a therapeutic regimen for the treatment of onychomycosis; and

a unifying container.

2. The article of manufacture of claim 1, wherein the nail growth monitoring device further comprises:

a substrate;

a nail growth measurement device coupled to the substrate, the nail growth measurement device including a plurality of measurement levels;

a marking region coupled to the substrate, the marking region including a plurality of notation-marking subareas respectively associated with the plurality of measurement levels.

3. The article of manufacture of claim 2, wherein the notation-marking subareas are regions separated by horizontal lines spaced apart at fixed increments.

5. The article of manufacture of claim 3, wherein the horizontal lines separating the notation marking are respectively connected to lines indicating measurement levels in the measurement device.

6. The article of manufacture of claim 5, wherein the spacing between the lines indicating measurement levels in the measurement device is narrower than the spacing between the horizontal lines separating the marking subareas.

7. The article of manufacture of claim 1, wherein the nail growth monitoring device comprises top, bottom and opposing side edges wherein one side edge comprises a first plurality of horizontal lines having a first spacing between the lines and the opposite edge comprises a second plurality of horizontal lines having a second spacing between the lines, wherein the first spacing is narrower than the second spacing, and lines connecting each of the first plurality of horizontal lines to each of the second plurality of horizontal lines.

8. The article of manufacture of claim 1, wherein the nail growth monitoring device further comprises indicia associating a plurality of toe nails with a corresponding nail growth measurement device and marking region with notation-marking subareas.

9. The article of manufacture of claim 1, wherein at least a portion of the nail growth monitoring device comprises a material that allows for at least semi-permanent markings to be made.

10. The article of manufacture of claim 9, wherein said material is positioned under at least a portion of the second plurality of horizontal lines.

11. The article of manufacture of claim 2, wherein at least a portion of the nail growth monitoring device comprises a transparent or translucent material.

12. The article of manufacture of claim 11, wherein the transparent or translucent material is positioned under at least a portion of the first plurality of lines.

13. The article of manufacture of claim 1, wherein the indicia for self diagnosis of onychomycosis are printed on a surface of the container.

14. The article of manufacture of claim 1, wherein the coordinating instructions are printed on a surface of the container.

15. The article of manufacture of claim 1, wherein the indicia for self diagnosis of onychomycosis are located inside the container.

16. The article of manufacture of claim 1, wherein the coordinating instructions are located inside the container.

17. The article of manufacture of claim 1, wherein the pharmaceutically active agent is present in an amount of 0.01 to 20% by weight.

18. The article of manufacture of claim 1, wherein the pharmaceutically active agent is present in an amount of 0.5 to 20% by weight.

19. The article of manufacture of claim 1, wherein the pharmaceutically active agent is present in an amount of 2 to 15% by weight.

20. The article of manufacture of claim 1, wherein the antifungal agent is chosen from the group consisting of miconazole, econazole, ketoconazole, itraconazole, fluconazole, bifoconazole, terconazole, butoconazole, tioconazole, oxiconazole, sulconazole, saperconazole, clotrimazole, isoconazole, butoconazole, clioquinol, lanoconazole, neticonazole, ciclopirox, butenafine, undecylenic acid, haloprogin, tolnaftate, nystatin, ciclopirox olamine, terbinafine, amorolfine, naftifine, elubiol, griseofulvin, corticosteroids, amphotericin, calcipotriene, anthraline, minoxidil, minoxidil sulfate, retinoids, cysteine, acetyl cysteine, methionine, glutathione, biotin, finasteride and ethocyn, tea tree oil, mupirocin, neomycin sulfate bacitracin, polymyxin B, I-ofloxacin, chlortetracycline hydrochloride, oxytetracycline hydrochloride, tetracycline hydrochoride, clindamycin phosphate, gentamicin sulfate, benzalkonium chloride, benzethonium chloride, hexylresorcinol, methylbenzethonium chloride, phenol, quaternary ammonium compounds, triclocarbon, triclosan, flucytosine, salicylic acid, fezatione, ticlatone, triacetin, zinc pyrithione and sodium pyrithione, mixtures thereof, pharmaceutically acceptable salts thereof and mixtures of pharmaceutically acceptable salts thereof.

21. The article of manufacture of claim 1, wherein the pharmaceutical composition further comprises a water insoluble film-forming substance.

22. The article of manufacture of claim 21, wherein the water insoluble film-forming substance comprises a substance chosen from the group consisting of cellulose nitrate, polyvinyl acetate, partially hydrolyzed polyvinyl acetate, copolymers of vinyl acetate containing acrylic acid, crotonic acid, and maleic acid monoalkyl esters, ternary copolymers of vinyl acetate comprising crotonic acid and vinyl neodecanoate, or crotonic acid and vinyl propionate, copolymers of methyl vinyl ether and maleic acid monoalkyl esters, copolymers of fatty acid vinyl esters and acrylic acid or methacrylic acid, copolymers of N-vinyl pyrrolidone, methacrylic acid and methacrylic acid alkyl esters, copolymers of acrylic acid and methacrylic acid or acrylic acid alkyl esters or methacrylic acid alkyl esters, polyvinyl acetals and polyvinyl butyrals, alkyl-substituted poly-N-vinylpyrrolidones, alkyl esters of copolymers of olefins and maleic anhydride and reaction products of colophony with acrylic acid, and mixtures thereof.

23. The article of manufacture of claim 1, wherein the pharmaceutical formulations further contain one or more topical formulation additives.

24. The article of manufacture of claim 23, wherein the one or more topical formulation additives are chosen from the group consisting of plasticizers, dyestuffs, colored pigments, nacreous agents, sedimentation retarders, sulfonamide resins, silicates, aroma substances, wetting agents, lanolin derivatives, light stabilizers, and substances having a keratolytic and/or keratoplastic action.

25. The article of manufacture of claim 24, wherein the substances with a keratolytic and/or keratoplastic action are chosen from the group consisting of ammonium sulfite, esters and salts of thioglycolic acid, urea, allantoin, enzymes and salicylic acid.

26. The article of manufacture of claim 1, wherein the pharmaceutical formulations further comprise one or more substances that are retentive in the stratum corneum.

27. The article of manufacture of claim 26, wherein the one or more substances that are retentive in the stratum corneum are present in an amount of 0.1 to 10% by weight, based on the whole weight of the composition.

28. The article of manufacture of claim 26, wherein the one or more substances that are retentive in the stratum corneum are present in an amount of 0.5 to 5% by weight, based on the whole weight of the composition.

29. The article of manufacture of claim 26, wherein the one or more substances that are retentive in the stratum corneum are present in an amount of 1 to 2% by weight, based on the whole weight of the composition.

30. The article of manufacture of claim 26, wherein the substance(s) that are retentive in the stratum corneum are chosen from the group consisting of methyl salicylate, glycol salicylate, crotamiton, peppermint oil and menthol.

31. The article of manufacture of claim 1, wherein the pharmaceutical formulations further comprise one or more dermal penetration enhancer.

32. The article of manufacture of claim 31, wherein the dermal penetration enhancer is chosen from the group consisting of C₈ to C₁₈ alkyl para-aminobenzoate, C₈ to C₁₈ alkyl dimethyl-para-aminobenzoate, C₈ to C₁₈ alkyl cinnamate, C₈ to C₁₈ alkyl methoxycinnamate or C₈ to C₁₈ alkyl salicylate and mixtures there of.

33. The article of manufacture of claim 32, wherein the dermal penetration enhancer is chosen from the group consisting of octyl salicylate, octyl dimethyl para-aminobenzoate, octyl para-methoxycinnamate, and mixtures thereof.

34. The article of manufacture of claim 1, wherein the indicia for self-diagnosis is a flow-chart and accompanying text.

35. The article of manufacture of claim 1, wherein the indicia for self-diagnosis is an interactive table with accompanying text.

95. The article of manufacture of claim 20, wherein the antifungal agent is ciclopirox or a pharmaceutically acceptable salt thereof.

96. The article of manufacture of claim 20, wherein the antifungal agent is butenafine or a pharmaceutically acceptable salt thereof.

97. The article of manufacture of claim 20, wherein the antifungal agent is terbinafine or a pharmaceutically acceptable salt thereof.

4. The article of manufacture of 2, wherein adjacent notation-marking subareas are differently colored.

36. An article of manufacture, comprising:

(a) at least one topically applied antifungal medication;

(b) a device to measure the effectiveness of using the antifungal medication(s); and

(c) instructions for coordination of the antifungal medication and the device as a treatment regimen.

37. The article of manufacture of claim 36, wherein said coordinating instructions including instructions on frequency of dosing and number of applications of said topically applied antifungal medication at each dosing.

98. The article of manufacture of claim 36, wherein the antifungal medication is ciclopirox or a pharmaceutically acceptable salt thereof.

99. The article of manufacture of claim 36, wherein the antifungal medication is butenafine or a pharmaceutically acceptable salt thereof.

100. The article of manufacture of claim 36, wherein the antifungal medication is terbinafine or a pharmaceutically acceptable salt thereof.

38. A medical therapy compliance management system for the treatment of onychomycosis with a topically applied antifungal agent, the system comprising:

instructions describing a self-diagnosis procedure for onychomycosis;

means for tracking growth of a nail, provided together with said instructions.

39. The system of claim 38, further comprising:

instructions describing proper nail trimming procedure, provided together with said instructions describing the self-diagnosis procedure.

40. The system of claim 38, further comprising instructions describing procedures for preventing onychomycosis relapse, provided together with said instructions describing the self-diagnosis procedure.

41. The system of claim 38, further comprising instructions for applying the antifungal agent, provided together with said instructions describing the self-diagnosis procedure.

42. The system of any of claim 39, 40 and 41, wherein at least one of said instructions describing proper nail trimming procedure, instructions describing procedures for preventing onychomycosis relapse, instructions for applying the antifungal agent, and instructions describing the self-diagnosis procedure are provided in a pre-printed form.

43. The system of any of claim 39, 40 and 41, wherein all of said instructions describing proper nail trimming procedure, instructions describing procedures for preventing onychomycosis relapse, instructions for applying the antifungal agent, and instructions describing the self-diagnosis procedure are provided in a pre-printed form.

44. The system of any of claim 39, 40 and 41, wherein at least one of said instructions describing proper nail trimming procedure, instructions describing procedures for preventing onychomycosis relapse, instructions for applying the antifungal agent, and instructions describing the self-diagnosis procedure are provided electronically.

45. The system of any of claim 39, 40 and 41, wherein all of said instructions describing proper nail trimming procedure, instructions describing procedures for preventing onychomycosis relapse, instructions for applying the antifungal agent, and instructions describing the self-diagnosis procedure are provided electronically.

46. The system of claim 38, further comprising:

a compliance controller configured to generate treatment reminders and send the generated treatment reminders towards a subject.

47. The system of claim 38, further comprising:

a compliance controller configured to receive information concerning treatment compliance from a subject.

48. The system of claim 47 wherein the compliance controller is configured to adjust the generation of the reminders based upon the received information concerning treatment compliance.

49. The system of claim 38 that is web-based.

50. The system of claim 46, wherein the reminders are sent electronically.

51. The system of claim 46, wherein the reminders comprise voice messages sent to a data receiving device.

52. The system of claim 46, wherein the reminders comprise text messages sent to a data receiving device.

53. The system of claim 46, wherein the reminders are sent to an e-mail account.

54. The system of claim 38 further comprising:

non-electronic means for reminding the subject to comply with treatment

55. The system of claim 54, wherein the non-electronic means comprise at least one of magnets or self-sticking visual aids.

101. The system of claim 38, wherein the antifungal agent is ciclopirox or a pharmaceutically acceptable salt thereof.

102. The system of claim 38, wherein the antifungal agent is butenafine or a pharmaceutically acceptable salt thereof.

103. The system of claim 38, wherein the antifungal agent is terbinafine or a pharmaceutically acceptable salt thereof.

56. A medical therapy management system for managing medical therapy to a patient, the system comprising:

an interactive system configured to obtain data from the patient; and

a compliance controller coupled to the interactive system, the compliance controller configured to receive data from the interactive system and to generate notifications to the patient based upon the data received from the patient.

57. A nail growth monitoring device comprising a surface with associations between nail growth and notation-marking subareas.

58. The nail growth monitoring device of claim 57, wherein the surface has top, bottom and opposing side edges.

59. The nail growth monitoring device of claim 58, wherein one side edge represents nail growth comprising a first plurality of horizontal lines having a first spacing between the lines and the opposite edge contains notation-marking subareas associated with the first side edge and comprises a second plurality of horizontal lines having a second spacing between the lines, wherein the first spacing is narrower than the second spacing, and lines connecting each of the first plurality of horizontal lines to each of the second plurality of horizontal lines.

60. The nail growth monitoring device of claim 57, wherein at least a portion of the device comprises a material that allows for at least semi-permanent markings to be made.

61. The nail growth monitoring device of claim 60, wherein said material is positioned under at least a portion of the second plurality of horizontal lines.

62. The nail growth monitoring device of claim 57, wherein at least a portion of the nail growth monitoring device comprises a transparent or translucent material.

63. The nail growth monitoring device of claim 62, wherein the transparent or translucent material is positioned under at least a portion of the first plurality of lines.

64. A method of administering a compliance program for nail treatment of onychomycosis, comprising:

providing instructions for the administration of a treatment of a nail growth condition based on a diagnosis of the nail growth condition;

providing a nail growth monitoring device;

providing a pharmaceutical composition for topical application comprising at least one antifungal agent;

registering a patient with a medical therapy compliance management system; and

updating patient information on the medical therapy compliance management system.

65. The method of claim 64, wherein the diagnosis is a self-diagnosis.

66. The method of claim 64, wherein the diagnosis is determined by a medical therapy compliance management system based on input from a patient.

67. The method of claim 64, wherein the diagnosis is input by a health care professional.

68. The method of claim 64, wherein the nail growth monitoring device further comprises:

a substrate;

a nail growth measurement device coupled to the substrate, the nail growth measurement device including a plurality of measurement levels;

a marking region coupled to the substrate, the marking region including a plurality of notation-marking subareas respectively associated with the plurality of measurement levels.

69. The method of claim 68, wherein the notation-marking subareas are horizontal lines spaced apart at fixed increments.

70. The method of claim 68, wherein the notation-marking subareas are differently colored.

71. The method of claim 68, wherein the nail growth monitoring device further comprises indicia associating a plurality of toe nails with a corresponding nail growth measurement device and marking region with notation-marking subareas.

72. The method of claim 68, wherein the nail growth monitoring device is provided over a network.

73. The method of claim 68, wherein the nail growth monitoring device is provided within a pre-packaged device.

74. The method of claim 64, wherein the antifungal agent is chosen from the group consisting of miconazole, econazole, ketoconazole, itraconazole, fluconazole, bifoconazole, terconazole, butoconazole, tioconazole, oxiconazole, sulconazole, saperconazole, clotrimazole, isoconazole, butoconazole, clioquinol, lanoconazole, neticonazole, ciclopirox, butenafine, undecylenic acid, haloprogin, tolnaftate, nystatin, ciclopirox olamine, terbinafine, amorolfine, naftifine, elubiol, griseofulvin, corticosteroids, amphotericin, calcipotriene, anthraline, minoxidil, minoxidil sulfate, retinoids, cysteine, acetyl cysteine, methionine, glutathione, biotin, finasteride and ethocyn, tea tree oil, mupirocin, neomycin sulfate bacitracin, polymyxin B, I-ofloxacin, chlortetracycline hydrochloride, oxytetracycline hydrochloride, tetracycline hydrochoride, clindamycin phosphate, gentamicin sulfate, benzalkonium chloride, benzethonium chloride, hexylresorcinol, methylbenzethonium chloride, phenol, quaternary ammonium compounds, triclocarbon, triclosan, flucytosine, salicylic acid, fezatione, ticlatone, triacetin, zinc pyrithione and sodium pyrithione, mixtures thereof, pharmaceutically acceptable salts thereof and mixtures of pharmaceutically acceptable salts thereof.

75. The method of claim 64, wherein the pharmaceutical composition further comprises a water insoluble film-forming substance.

76. The method of claim 64, wherein the pharmaceutical formulations further contain one or more topical formulation additives.

77. The method of claim 64, wherein the pharmaceutical formulations further comprise one or more substances that are retentive in the stratum corneum.

78. The method of claim 64, wherein the pharmaceutical formulations further comprise one or more dermal penetration enhancer.

79. The method of claim 64, wherein the pharmaceutical composition is chosen by a doctor.

80. The method of claim 64, wherein the pharmaceutical composition is determined by the medical therapy compliance management system based on input from the patient.

81. The method of claim 64, wherein a patient is registered with a code provided on the nail growth monitoring device.

82. The method of claim 64, wherein a patient is registered with a personal contact.

83. The method of claim 64, further comprising sending reminders to a patient'"'"'s personal contact.

84. The method of claim 64, further comprising modifying instructions for the administration of the nail growth condition, wherein the modifications are based on progress input by the patient.

104. The method of claim 74, wherein the antifungal agent is ciclopirox or a pharmaceutically acceptable salt thereof.

105. The method of claim 74, wherein the antifungal agent is butenafine or a pharmaceutically acceptable salt thereof.

106. The method of claim 74, wherein the antifungal agent is terbinafine or a pharmaceutically acceptable salt thereof.

85. A nail growth monitoring device, comprising:

a substrate;

a nail growth measurement device coupled to the substrate, the nail growth measurement device including a plurality of measurement levels;

a marking region coupled to the substrate, the marking region including a plurality of notation-marking subareas respectively associated with the plurality of measurement levels.

86. The nail growth monitoring device of claim 85, wherein the notation-marking subareas are regions separated by horizontal lines spaced apart at fixed increments.

90. The nail growth monitoring device of claim 85, wherein the nail growth monitoring device comprises top, bottom and opposing side edges wherein one side edge comprises a first plurality of horizontal lines having a first spacing between the lines and the opposite edge comprises a second plurality of horizontal lines having a second spacing between the lines, wherein the first spacing is narrower than the second spacing, and lines connecting each of the first plurality of horizontal lines to each of the second plurality of horizontal lines.

91. The nail growth monitoring device of claim 85, wherein the nail growth monitoring device further comprises indicia associating a plurality of toe nails with a corresponding nail growth measurement device and marking region with notation-marking subareas.

92. The nail growth monitoring device of claim 85, wherein at least a portion of the nail growth monitoring device comprises a material that allows for at least semi-permanent markings to be made.

93. The nail growth monitoring device of claim 92, wherein said material is positioned under at least a portion of the second plurality of horizontal lines.

94. The nail growth monitoring device of claim 85, wherein at least a portion of the nail growth monitoring device comprises a transparent or translucent material.

87. The nail growth monitoring device of 85, wherein adjacent notation-marking subareas are differently colored.

88. The nail growth monitoring device of claim 87, wherein the horizontal lines separating the notation marking are respectively connected to lines indicating measurement levels in the measurement device.

89. The nail growth monitoring device of claim 88, wherein the spacing between the lines indicating measurement levels in the measurement device is narrower than the spacing between the horizontal lines separating the marking subareas.