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Off-label indications for imiquimod
1. Department of Dermatology, University of California, Irvine, Irvine, California
2. Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California
3. Department of Dermatology, University of California, San Francisco, San Francisco, CA, USA; and Palo Alto Foundation Medical Group, Mountain View, California. jemurase@gmail.com
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10. Blasi MA, Giammaria D, Balestrazzi E. Immunotherapy with imiquimod 5% cream for eyelid nodular basal cell carcinoma. Am J Ophthalmol. 2005 Dec;140(6):1136-9. [PubMed]
11. Bong AB, Bonnekoh B, Franke I, Schön MP, Ulrich J, Gollnick H. Imiquimod, a Topical Immune Response Modifier, in the Treatment of Cutaneous Metastases of Malignant Melanoma. Dermatology. 2002;205:135-138. [PubMed]
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13. Boonchai W. Treatment of precancerous and cancerous lesions of chronic arsenicism with 5% imiquimod cream. Arch Dermatol. 2006 Apr;142(4):531-2. [PubMed]
14. Brannan PA, Anderson HK, Kersten RC, Kulwin DR. Bowen disease of the eyelid successfully treated with imiquimod. Ophthal Plast Reconstr Surg. 2005;21(4):321-322. [PubMed]
15. Buckley R, Smith K. Topical imiquimod therapy for chronic giant molluscum contagiosum in a patient with advanced human immunodeficiency virus 1 disease. Arch Dermatol. 1999;135:1167-1169. [PubMed]
16. Campagne G, Roca M, Martinez A. Successful treatment of a high-grade intraepithelial neoplasia with imiquimod, with vulvar pemphigus as a side effect. Eur J Obstet Gynecol Reprod Biol. 2003;109:224-227. [PubMed]
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18. Cohen PR, Schulze KE, Tschen JA, Hetherington GW, Nelson BR. Treatment of extramammary Paget disease with topical imiquimod cream: case report and literature review. South Med J. 2006 Apr;99(4):396-402. [PubMed]
19. Coors EA, Schuler G, Von Den Driesch P. Topical imiquimod as treatment for different kinds of cutaneous lymphoma. Eur J Dermatol. 2006;16:391-393. [PubMed]
20. Curiel-Lewandrowski C, Williams CM, Swindells KS, Tahan SR, Astner S, Frankenthaler RA, González S. Use of In Vivo Confocal Microscopy in Malignant Melanoma. Arch Dermatol. 2004;140:1127-1132. [PubMed]
21. Danielsen AG, Petersen CS, Iversen J. Chronic erosive herpes simplex virus infection of the penis in a human immunodeficiency virus-positive man, treated with imiquimod and famciclovir. Br J Dermatol. 2002 Nov;147(5):1034-6. [PubMed]
22. Danielsen AG, Sand C, Weismann K. Treatment of Bowen's disease of the penis with imiquimod 5% cream. Clin Exp Dermatol. 2003;28(1):7-9. [PubMed]
23. Deeths MJ, Chapman JT, Dellavalle RP, Zeng C, Aeling JL. Treatment of patch and plaque stage mycosis fungoides with imiquimod 5% cream. J Am Acad Dermatol. 2005 Feb;52(2):275-80. [PubMed]
24. Dendorfer M, Oppel T, Wollenberg A, Prinz JC. Topical treatment with imiquimod may induce regression of facial keratoacanthoma. Eur J Dermatol. 2003 Jan-Feb;13(1):80-2. [PubMed]
25. Denkler K, Kivett WF. Topical treatment of nasal keratoacanthoma. Plast Reconstr Surg. 2006;117:2516-2517. [PubMed]
26. Di Lernia V, Ricci C, Albertini G. Spontaneous regression of keratoacanthoma can be promoted by topical treatment with imiquimod cream. J Eur Acad Dermatol Venereol. 2004;18:626-629. [PubMed]
27. Diaz-Arrastia C, Arany I, Robazetti SC, Dinh TV, Gatalica Z. Clinical and molecular responses in high-grade intraepithelial neoplasia treated with topical imiquimod 5%. Clin Cancer Res. 2001;7:3031-3033. [PubMed]
28. Didona B, Benucci R, Amerio P, Canzona F, Rienzo O, Cavalieri R. Primary cutaneous CD30+ T-cell lymphoma responsive to topical imiquimod (Aldara). Br J Dermatol. 2004 Jun;150(6):1198-201. [PubMed]
29. Dirschka T, Krahl D, Oster-Schmidt C. Multifocal penile intraepithelial neoplasia--targeted treatment with imiquimod. J Dtsch Dermatol Ges. 2006;4:559-562. [PubMed]
30. D'Ovidio R, Claudatus J, Di Prima T. Ineffectiveness of imiquimod therapy for Alopecia Totalis/Universalis. J Eur Acad Dermatol Venereol. 2002;16:416-417. [PubMed]
31. Dusza SW, Delgado R, Busam KJ, Marghoob AA, Halpern AC. Treatment of dysplastic nevi with 5% imiquimod cream, a pilot study. J Drugs Dermatol. 2006;5(1):56-62. [PubMed]
32. Dytoc M, Ting PT, Man J, Sawyer D, Fiorillo L. First case series on the use of imiquimod for morphoea. Br J Dermatol. 2005;153(4):815-20. [PubMed]
33. Epstein E. Extensive Lentigo Maligna Clearing With Topical Imiquimod. Arch Dermatol. 2003;139:944-945. [PubMed]
34. Erbağci Z, Erbağci I, Almila Tuncel A. Rapid improvement of human orf (ecthyma contagiosum) with topical imiquimod cream: report of four complicated cases. J Dermatolog Treat. 2005;16(5-6):353-6. [PubMed]
35. Erbagci Z, Tuncel AA, Erkilic S, Zer Y. Successful treatment of antifungal- and cryotherapy-resistant subcutaneous hyalohyphomycosis in an immunocompetent case with topical 5% imiquimod cream. Mycopathologia. 2005;159(4):521-6. [PubMed]
36. Ezzell TI, Fromowitz JS, Ramos-Caro FA. Recurrent pyogenic granuloma treated with topical imiquimod. J Am Acad Dermatol. 2006;54:244-245. [PubMed]
37. Fernandez-Vozmediano J, Armario-Hita J. Infiltrative squamous cell carcinoma on the scalp after treatment with 5% imiquimod cream. J Am Acad Dermatol. 2005;53:137. [PubMed]
38. Fisher GH. Treatment of Melanoma In Situ on Sun-Damaged Skin With Topical 5% Imiquimod Cream Complicated by the Development of Invasive Disease. Arch Dermatol. 2003;139:945-947. [PubMed]
39. Fleming CJ, Bryden AM, Evans A, Dawe RS, Ibbotson SH. A pilot study of treatment of lentigo maligna with 5% imiquimod cream. Br J Dermatol. 2004;151(2):485-8. [PubMed]
40. Frega A, Rech F, French D. Imiquimod treatment of vulvitis circumscripta plasmacellularis. Int J Gynaecol Obstet. 2006;95(2):161-2. [PubMed]
41. Gardner LS, Ormond PJ. Treatment of multiple giant molluscum contagiosum in a renal transplant patient with imiquimod 5% cream. Clin Exp Dermatol. 2006;31:452-453. [PubMed]
42. Giannotti B, Vanzi L, Difonzo EM, Pimpinelli N. The treatment of basal cell carcinomas in a patient with xeroderma pigmentosum with a combination of imiquimod 5% cream and oral acitretin. Clin Exp Dermatol. 2003;28 Suppl 1:33-5. [PubMed]
43. Gilbert J, Drehs MM, Weinberg JM. Free Full TextGilbert J, Drehs MM, Weinberg JM. Topical imiquimod for acyclovir-unresponsive herpes simplex virus 2 infection. Arch Dermatol. 2001;137(8):1015-7. [PubMed]
44. Godfrey JC, Vaughan MC, Williams JV. Successful treatment of bowenoid papulosis in a 9-year-old girl with vertically acquired human immunodeficiency virus. Pediatrics. 2003;112:e73-76. [PubMed]
45. Goihman-Yahr M. Combined immunotherapy of recalcitrant warts. Int J Dermatol. 2006;45:627. [PubMed]
46. Goorney BP, Polori R. A case of Bowenoid papulosis of the penis successfully treated with topical imiquimod cream 5%. Int J STD AIDS. 2004;15:833-835. [PubMed]
47. Gul U, Gonul M, Cakmak SK, Kilic A, Demiriz M. A case of generalized discoid lupus erythematosus: successful treatment with imiquimod cream 5%. Adv Ther. 2006;23:787-792. [PubMed]
48. Gutzmer R, Kaspari M, Vogelbruch M,Kiehl P, Kapp A.,Werfel T.,Brodersen J-P. Successful treatment of anogenital Bowen's disease with the immunomodulator imiquimod, and monitoring of therapy by DNA image cytometry. BJD. 2002; 147 (1): 160-165. [PubMed]
49. Haidopoulos D, Diakomanolis E, Rodolakis A, Voulgaris Z, Vlachos G, Intsaklis A. Can local application of imiquimod cream be an alternative mode of therapy for patients with high-grade intraepithelial lesions of the vagina? Int J Gynecol Cancer. 2005;15:898-902. [PubMed]
50. Harrison S, Harrison, Sinclair R. Porokeratosis of Mibelli: Successful treatment with topical 5% imiquimod cream. Australasian Journal of Dermatology. 2003;44:281-283. [PubMed]
51. Hengge UR, Esser S, Schultewolter T, Behrendt C, Meyer T, et al. Self-administered topical 5% imiquimod for the treatment of common warts and molluscum contagiosum. Br J Dermatol. 2000;143:1026-1031. [PubMed]
52. Hengge UR, Roth S, Tannapfel A. Topical imiquimod to treat recurrent breast cancer. Breast Cancer Res Treat. 2005;94(1):93-4. [PubMed]
53. Hengge UR, Stark R. Topical imiquimod to treat intraepidermal carcinoma. Arch Dermatol. 2001;137(6):709-11. [PubMed]
54. Herron MD, Bowen AR, Krueger GG. Seborrheic keratoses: a study comparing the standard cryosurgery with topical calcipotriene, topical tazarotene, and topical imiquimod. Int J Dermatol. 2004;43(4):300-2. [PubMed]
55. Hesling C, D'Incan M, Mansard S, Franck F, Corbin-Duval A, et al. In vivo and in situ modulation of the expression of genes involved in metastasis and angiogenesis in a patient treated with topical imiquimod for melanoma skin metastases. BJD. 2004;150 (4): 761-767. [PubMed]
56. Hughes PS. Treatment of lymphomatoid papulosis with imiquimod 5% cream. J Am Acad Dermatol. 2006;54(3):546-7. [PubMed]
57. Jain S. Successful treatment of porokeratosis of Mibelli with imiquimod 5% cream. Clin Exp Dermatol. 2006;31:302-303. [PubMed]
58. Jo JH, Ko HC, Jang HS, Kim MB, Oh CK, Kwon KS. Infiltrative trichilemmal carcinoma treated with 5% imiquimod cream. Dermatol Surg. 2005;31(8 Pt 1):973-6. [PubMed]
59. Kelly SC, Purcell SM. Imiquimod therapy for elastosis perforans serpiginosa. Arch Dermatol. 2006;142(7):829-30. [PubMed]
60. Kim YJ, Kim JW, Koh BK. Successful treatment of vulvar Bowen's disease with topical imiquimod 5% cream. Int J Dermatol. 2006;45(2):151-153. [PubMed]
61. Kreuter A, Hochdorfer B, Stucker M, Altmeyer P, Weiland U. Treatment of anal intraepithelial neoplasia in patients with acquired HIV with imiquimod 5% cream. J Am Acad Dermatol. 2004;50:980-981. [PubMed]
62. Kupfer-Bessaguet I., Guillet G.,Misery L., Carre J.L., Leroy J.P., Sassolas B. Topical imiquimod treatment of lentigo maligna: Clinical and histologic evaluation. J Am Acad Dermatol. 2004; 51(4):635-639. [PubMed]
63. Kuwahara RT, Naylor MF, Skinner RB. Treatment of granuloma annulare with topical 5% imiquimod cream. Pediatr Dermatol. 2003;20(1):90. [PubMed]
64. Kuwahara RT, Skinner RB. Granuloma annulare resolved with topical application of imiquimod. Pediatr Dermatol. 2002;19(4):368-71. [PubMed]
65. Lain EL, Carrington PR. Imiquimod treatment of exuberant granulation tissue in a nonhealing diabetic ulcer. Arch Dermatol. 2005;141(11):1368-70. [PubMed]
66. Le T, Hicks W, Menard C, Hopkins L, Fung MF. Preliminary results of 5% imiquimod cream in the primary treatment of vulva intraepithelial neoplasia grade 2/3. Am J Obstet Gynecol. 2006;194:377-380. [PubMed]
67. Lonsdale-Eccles AA, Morgan JM, Nagarajan S, Cruickshank DJ. Successful treatment of vulval melanoma in situ with topical 5% imiquimod cream. Br J Dermatol. 2006;155(1):215-217. [PubMed]
68. Loo WJ, Holt PJ. Bowenoid papulosis successfully treated with imiquimod. J Eur Acad Dermatol Venereol. 2003;17:363-365. [PubMed]
69. Mackenzie-Wood A, Kossard S, Launey J, Wilkinson B, Owens M. Imiquimod 5% cream in the treatment of Bowen's disease. J Am Acad Dermatol. 2001;44:462-470. [PubMed]
70. Marchitelli C, Secco G, Perrotta M, Lugones L, Pesce R. Treatment of bowenoid and basaloid vulvar intraepithelial neoplasia 2/3 with imiquimod 5% cream. J Reprod Med. 2004;49:876-882. [PubMed]
71. Martinez MI, Sanchez-Carpintero I, North PE, Mihm MC. Clinical Resolution With 5% Imiquimod Cream. Arch Dermatol. 2002;138:881-884. [PubMed]
72. Martinez S, del Boz J, Vera A, Sanz A, Crespo V. Spindle-cell carcinoma in situ treated with 5% imiquimod. Actas Dermosifiliogr. 2006;97(4):267-70. [PubMed]
73. Martinez V, Molina JM, Scieux C, Ribaud P, Morfin F. Topical imiquimod for recurrent acyclovir-resistant HSV infection. Am J Med. 2006;119:e9-11. [PubMed]
74. Martin-Garcia RF. Imiquimod: an effective alternative for the treatment of invasive cutaneous squamous cell carcinoma. Dermatol Surg. 2005;31:371-374. [PubMed]
75. Maschke J, Brauns TC, Goos M. Imiquimod for the topical treatment of focal epithelial hyperplasia (Heck disease) in a child. J Dtsch Dermatol Ges. 2004;2(10):848-850. [PubMed]
76. Micali G, Nasca MR, De Pasquale R. Erythroplasia of Queyrat treated with imiquimod 5% cream. J Am Acad Dermatol. 2006;55(5):901-3. [PubMed]
77. Micali G, Nasca MR, Tedeschi A. Topical treatment of intraepithelial penile carcinoma with imiquimod. Clin Exp Dermatol. 2003;28 (1):4-6. [PubMed]
78. Micantonio T, Fargnoli MC, Peris K. Usefulness of Dermoscopy to Monitor Clinical Efficacy of Imiquimod Treatment for Lentigo Maligna. Arch Dermatol. 2006;142:530-531. [PubMed]
79. Miranda-Verastegui C, Llanos-Cuentas A, Arevalo I, Ward BJ, Matlashewski G. Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru. Clin Infect Dis. 2005;40(10):1395-403. [PubMed]
80. Muhlstadt M, Kerschenlohr K, Scharrer EM, Pfutzner W, Korting HC. Juvenile verrucae planae : Treatment with imiquimod 5% cream. Hautarzt. 2007;58(1):54-55. [PubMed]
81. Nagore E, Sevila A, Sanmartin O, Botella-Estrada R, Requena C, Serra-Guillen C, Sanchez-Pedreño P, Guillen C. Excellent response of basal cell carcinomas and pigmentary changes in xeroderma pigmentosum to imiquimod 5% cream. Br J Dermatol. 2003 Oct;149(4):858-61. [PubMed]
82. Naylor MF, Crowson N, Kuwahara R, Teague K, Garcia C, Mackinnis C, Haque R, Odom C, Jankey C, Cornelison RL. Treatment of lentigo maligna with topical imiquimod. Br J Dermatol. 2003;149 Suppl 66:66-70. [PubMed]
83. Nijsten T, Lapiere K, Lambert J. A patient with xeroderma pigmentosum treated with imiquimod 5% cream. J Am Acad Dermatol. 2005;52(1):170-1. [PubMed]
84. Pehoushek J, Smith KJ. Imiquimod and 5% Fluorouracil Therapy for Anal and Perianal Squamous Cell Carcinoma In Situ in an HIV-1-Positive Man. Arch Dermatol. 2001;137:14-16. [PubMed]
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86. Petrow W, Gerdsen R, Uerlich M, Richter O, Bieber T. Successful topical immunotherapy of bowenoid papulosis with imiquimod. Br J Dermatol. 2001;145:1022-1023. ]
87. Poluri RM, Higgins SP. Successful treatment of penile Bowen's disease with 5% imiquimod cream. Int J STD AIDS. 2005;16(9):649. [PubMed]
88. Powell AM, Russell-Jones R. Amelanotic lentigo maligna managed with topical imiquimod as immunotherapy. J Am Acad Dermatol. 2004; 50(5):792-796. [PubMed]
89. Prado A, Andrades P, Benitez S, Umaña M. Scar management after breast surgery: preliminary results of a prospective, randomized, and double-blind clinical study with aldara cream 5% (imiquimod). Plast Reconstr Surg. 2005;115(3):966-72. [PubMed]
90. Prado A, Andrades P, Benitez S. Preliminary results after face peels using Aldara cream 5% (imiquimod). Plast Reconstr Surg. 2005;116(5):1563-8. [PubMed]
91. Prinz BM, Hafner J, Dummer R, Burg G, Bruswanger U, Kempf W. Treatment of Bowen's disease with imiquimod 5% cream in transplant recipients. Transplantation. 2004;77(5):790-791. [PubMed]
92. Redondo P, Del Olmo J, Idoate M. Angiolymphoid hyperplasia with eosinophilia successfully treated with imiquimod. Br J Dermatol. 2004 Nov;151(5):1110-1. [PubMed]
93. Ricart JM, Cordoba J, Hernandez M, Esplugues I. Extensive genital bowenoid papulosis responding to imiquimod. J Eur Acad Dermatol Venereol. 2007;21:113-115. [PubMed]
94. Richter ON, Petrow W, Wardelmann E, Dorn C, Kupka M, Ulrich U. Bowenoid papulosis of the vulva-immunotherapeutical approach with topical imiquimod. Arch Gynecol Obstet. 2003;268(4):333-6. [PubMed]
95. Rinaggio J, Glick M, Lambert WC. Oral bowenoid papulosis in an HIV-positive male. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006;101:328-332. [PubMed]
96. Rinne D, Linhart C, Schofer H. Lip papillomatosis in immunodeficiency: therapy with imiquimod. Br J Dermatol. 2000;142(1):196-7. [PubMed]
97. Rodriguez E, Villanueva Pena A, Hernandez Castrillo A, Gomez Ortega JM. Treatment of Bowen's disease of the penis with imiquimod 5% cream. Actas Urol Esp. 2005;29(8):797-800.
98. Roseeuw D. The treatment of basal skin carcinomas in two sisters with xeroderma pigmentosum. Clin Exp Dermatol. 2003;28 Suppl 1:30-2. [PubMed]
99. Rosen T. Limited extent AIDS-related cutaneous Kaposi's sarcoma responsive to imiquimod 5% cream. Int J Dermatol. 2006;45(7):854-6. [PubMed]
100. Ross GL, Orchard DC. Combination topical treatment of molluscum contagiosum with cantharidin and imiquimod 5% in children: a case series of 16 patients. Australas J Dermatol. 2004;45:100-102. [PubMed]
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102. Sachse MM, Zimmermann J, Bahmer FA. Efficiency of topical imiquimod 5% cream in the management of chronic radiation dermatitis with multiple neoplasias. Eur J Dermatol. 2006;16(1):56-8. [PubMed]
103. Schalock PC, Kornik RI, Baughman RD, Chapman MS. Treatment of verrucous carcinoma with topical imiquimod. J Am Acad Dermatol. 2006;54(5 Suppl):S233-5. [PubMed]
104. Schoen M.P. British Journal of Dermatology. 2007;157(2 Suppl):8-13.
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106. Smith KJ, Germain M, Skelton H. Bowen's disease (squamous cell carcinoma in situ) in immunosuppressed patients treated with imiquimod 5% cream and a cox inhibitor, sulindac: potential applications for this combination of immunotherapy. Dermatol Surg.2001;27(2):143-146. [PubMed]
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109. Spaner DE, Miller RL, Mena J, Grossman L, Sorrenti V, Shi Y. Regression of lymphomatous skin deposits in a chronic lymphocytic leukemia patient treated with the Toll-like receptor-7/8 agonist, imiquimod. Leuk Lymphoma. 2005;46(6):935-9. [PubMed]
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114. Stockfleth E, Röwert J, Arndt R, Christophers E, Meyer T. Detection of human papillomavirus and response to topical 5% imiquimod in a case of stucco keratosis. Br J Dermatol. 2000;143(4):846-50; [PubMed]
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116. Suchin KR, Junkins-Hopkins JM, Rook AH. Treatment of Stage IA Cutaneous T-Cell Lymphoma With Topical Application of the Immune Response Modifier Imiquimod. Arch Dermatol. 2002;138:1137-1139. [PubMed]
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118. Taverna JA, Stefanato CM, Wax FD, Demierre MF. Adult cutaneous Langerhans cell histiocytosis responsive to topical imiquimod. J Am Acad Dermatol. 2006;54(5):911-3. [PubMed]
119. Todd RW, Etherington IJ, Luesley DM. The effects of 5% imiquimod cream on high-grade vulval intraepithelial neoplasia. Gynecol Oncol. 2002;85(1):67-70. [PubMed]
120. Ugurel S, Wagner A, Pfohler C, Tilgen W, Reinhold U. Topical imiquimod eradicates skin metastases of malignant melanoma but fails to prevent rapid lymphogenous metastatic spread. Br J Dermatol. 2002;147(3):621-4. [PubMed]
121. Urquhart JL, Weston WL. Treatment of multiple trichoepitheliomas with topical imiquimod and tretinoin. Pediatr Dermatol. 2005;22(1):67-70. [PubMed]
122. Uysal AC. Topical interferon-alpha2b and keloid treatment: a place for pretreatment? Plast Reconstr Surg. 2006;117:1645-1646. [PubMed]
123. van Poelgeest MI, van Seters M, van Beurden M, Kwappenberg KM, Heijmans-Antonissen C, Drijfhout JW, Melief CJ, Kenter GG, Helmerhorst TJ, Offringa R, van der Burg SH. Detection of human papillomavirus (HPV) 16-specific CD4+ T-cell immunity in patients with persistent HPV16-induced vulvar intraepithelial neoplasia in relation to clinical impact of imiquimod treatment. Clin Cancer Res. 2005;11(14):5273-80. [PubMed]
124. van Seters M, Fons G, van Beurden M. Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study. J Reprod Med. 2002;47(9):701-5. [PubMed]
125. Weisberg NK, Varghese M. Therapeutic response of a brother and sister with xeroderma pigmentosum to imiquimod 5% cream. Dermatol Surg. 2002;28(6):518-23. [PubMed]
126. Welsh O, Olazarán Z, Gómez M, Salas J, Berman B. Treatment of infantile hemangiomas with short-term application of imiquimod 5% cream. J Am Acad Dermatol. 2004;51(4):639-42. [PubMed]
127. Wendling J, Saiag P, Berville-Levy S, Bourgault-Villada I, Clerici T. Treatment of undifferentiated vulvar intraepithelial neoplasia with 5% imiquimod cream: a prospective study of 12 cases. Arch Dermatol. 2004;140:1220-1224. [PubMed]
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Off-label indications for imiquimod
Published Web Location
https://doi.org/10.5070/D302v86610Main Content
Off-label indications for imiquimod
Shahrouz Ganjian1, Ariel J Ourian1, GabrEal Shamtoub1, Jashin J Wu MD2, Jenny E Murase MD3
Dermatology Online Journal 15 (5): 4
1. Department of Dermatology, University of California, Irvine, Irvine, California2. Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California
3. Department of Dermatology, University of California, San Francisco, San Francisco, CA, USA; and Palo Alto Foundation Medical Group, Mountain View, California. jemurase@gmail.com
Abstract
Due to the ability of imiquimod (Aldara™, 3M Pharmaceuticals) to rapidly and potently stimulate both innate and adaptive arms of the immune system, imiquimod has rapidly been recognized as a potential candidate for off-label use in over 60 conditions as presented in numerous case reports, letters, and small trials. It is our goal to examine and consolidate this impressive body of literature in order to provide the practicing dermatologist with a quick reference of the conditions that have been successfully treated with imiquimod, the dosages used, and the success rates of treatments.
Introduction
Imiquimod (Aldara™, 3M Pharmaceuticals), is currently FDA-approved for treatment of external genital and perianal warts (1997), non hypertrophic actinic keratoses in immunocompetent individuals (2004), and superficial basal cell carcinoma (2004). Imiquimod binds to Toll-like receptor 7, resulting in activation of monocytes, macrophages, and dendritic cells and stimulation of the release of proinflammatory cytokines- including IFN-α, TNF-α, and IL-1, 6, 8, 10, and 12. It also results in activation of T-helper 1 cells.
Because to its ability to rapidly and potently stimulate both innate and adaptive arms of the immune system, imiquimod has rapidly been recognized as a potential candidate for off-label use in over 60 conditions as presented in numerous case reports, letters, and small trials. It is our goal to examine and consolidate this impressive body of literature in order to provide the practicing dermatologist with a quick reference of the conditions that have been successfully treated with imiquimod, the dosages used, and the success rates of treatments.
Methods
A literature search was performed in PubMed for imiquimod (last performed in April 2007) and these studies were cross-matched with different skin pathologies. All clinical trials, randomized controlled trials, and/or multicenter studies in humans were included. Case reports and retrospective case series were also incorporated. Relevant studies were appraised. All studies regarding FDA-approved uses were excluded. One-hundred thirty-four studies discussing 62 conditions were ultimately included. Table 1 (Off-label Usages) groups studies according to indication, study design, dosage/frequency used, and efficacy.
Discussion
Imiquimod, a novel synthetic compound and member of the imidazoquinolone family of drugs, is commercially available as Aldara™ (3M Pharmaceuticals). In 1997, the Food and Drug Administration approved imiquimod and determined it to be safe and effective for treatment of external genital and perianal warts. Following more clinical studies, this drug has been approved for treatment of non-hypertrophic actinic keratoses in immunocompetent individuals and superficial basal cell carcinoma. Imiquimod is a unique topical cream because it can modify and stimulate the body's immune response. Imiquimod binds to Toll-like receptor 7, present on dendritic cells, macrophages, and monocytes, leading to the activation of nuclear factor-kappa B (NF-kB). This induces secretion of pro-inflammatory cytokines, predominantly interferon (IFN)-α, tumor necrosis factor (TNF)-α and interleukin (IL)-1, 6, 8, 10, and 12. These pro-inflammatory cytokines activate T-helper 1 cells and inhibit T-helper 2 cells. Imiquimod's therapeutic role as an antiviral and antitumoral drug is due to its ability to induce 2'5'-oligoadenylate synthase, which in turn activates Natural Killer Cells and perforin in cytotoxic T-cells. In addition, it directly induces apoptosis through activation of pro-apoptotic Bcl-2 proteins of the mitochondrial pathway.
In recent years, imiquimod has rapidly been recognized as a potential candidate for off-label use. Although the FDA has approved imiquimod only for the treatment of external genital and perianal warts, actinic keratoses, and superficial basal cell carcinoma, successful clinical studies teach the greater potential and efficacy of imiquimod in treating more cutaneous viral lesions. This review article has reported one-hundred thirty four studies discussing over 63 dermatological diseases, including skin cancers (squamous cell carcinoma, Bowen's disease), Vulvar intraepithelial neoplasia, Molluscum contagiosum, and lentigo maligna. Most of the clinical cases reported complete clearance with no evidence of reoccurance.
Although imiquimod has shown strong therapeutic results, it does have its dangers. As with all drugs, side effects may occur when using imiquimod and the severity of effect is dose-dependent. Imiquimod application dosage varies depending on the type of disease. Most patients applied the cream 3 times a week for 5 to 7 months. The most common side effect is application site reaction, such as itching, burning, bleeding, stinging, pain, induration, tenderness, and irritation. Other side effects include upper respiratory tract infection, sinusitis, and headache. Pregnant women should use imiquimod only if the potential benefits outweigh the risks. Many drugs are excreted in human milk, but imiquimod excretion in human milk has not been reported. Nevertheless, caution needs to be taken when using this drug. Clinicians should also be aware of pigmentation changes in patients.
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