Off-label Indications for Imiquimod
Disease name Study first author/year [# participants] *=Randomized controlled trial Study description (w=week, m=month, d=day, qd=once a day, bid=twice a day, apps=applications) Clearance (%) P=Partial C=Complete N=No response % with no evidence of recurrence X follow-up period Comments
Lentigo maligna          
Naylor 2003 [28]*   93C 80% 1yr  
Powell 2004 [12] qhs-3x/w x 5m 100C 100% 18m,100% 9m  
Ahmed 2000 [1] qd-3x/w x 7m 100C 100% 9m  
Fleming 2004 [6] qd x 6w 66P/C    
Kupfer-Bessaguet 2004 [2] 3x/w x 5m 100C 100% 14m,13m  
Curiel-Lewandrowski 2004 [1] qd x 4 w, q3d x 6m    
Epstein 2003 [1] qd x 5w 100C 100% 18m  
Fisher 2003 [1] qhs-3x/w x 9m 100C 100% 17m  
Micantonio 2005 [1] qd-5x/w x 12w 100C 100% 24m  
Cutaneous melanoma metastases          
Bong 2002 [3] qd x 21-28w 66P    
Hesling 2004 [1] qd x 8w 100C    
Steinmann 2000 [1] 3x/w x 12w 100P    
  Ugurel 2002 [1] qd x 12w 100C    
Zeitouni 2005 [1] 28w 100C    
Lonsdale-Eccles 2006 [1] q2d x 3w, qd x 3m 100C 100% 14m  
Intraepithelial melanoma of oral mucosa          
Spieth 2006 [1] 3x/w x 3m, 2x/w x 3m 100C 100% 13m  
Dysplastic nevi          
  Dusza 2006 [10] 3x/w x16w 29P    
Bowen’s disease: SCC in situ          
Mackenzie-Wood 2001 [16] qd x 16w 100 C 100% 6m  
Smith 2002 [5] qd x 16w 100C 100% 14m With sulindac 200mg
Danielsen 2003 [1] 3x/w x 5w      
Micali 2003 [2] 8-10w 100C 100% 6m  
Gutzmer 2002 [1] 3x/w x 20m 100P 100% 6m  
Kim 2006 [1] 3x/w x 16w 100P 100%  
Rodriguez 2005 [1] 3x/w x 5w      
Poluri 2005 [1] 3x/w x2m 100C 100% 7m  
Brannan 2005 [1] bid-q2d x 1m, qd x 2m 100C 100% 5m  
Prinz 2004 [4] 3x/w x2w, qd x 4w 75C 75% 6m  
Wu 2003 [1] q2d x 9w 100C 100% 1yr  
Smith 2001 [5] bid x 16w 100C 100% 5-14m With sulindac 200 mg bid
Peris 2006 [10] 5x/w x 16w 25P, 80C, 71C 100% 31m  
Spindle-cell carcinoma in situ          
Martinez 2006 [1] 4x/w x 8w 100C 100% 1yr  
Vulvar intraepithelial neoplasia (VIN)          
Van Seters 2002 [15] 3x/w x 34w 60P, 27C    
Todd 2002 [15] 3x/w x 16w      
Le 2006 [23] qw x 2w, 2x/w x 2w, 3x/w x 12w 24P, 43C    
Haidopoulos 2005 [7] 3x/w x 8w 86P    
van Poelgeest 2005 [17] 2x/w x 16w 76-100C    
Marchitelli 2004 [8] 3x/w x 16w 25P, 75C    
Wendlings 2003 [12] 3x/w x 7m 33P, 25C, 41N    
Campagne 2003 [1] 10apps x 8w 100C 100%  
Diaz-Arrastia 2001 [8] 3x/w x 6-16w 25P, 50C 100% 3-33m  
Vulvitis circumscripta plasmacellularis          
Frega 2006 [2] 2x/w x 2w, 3x/w x 8w 100C 100% 3y  
Anal intraepithelial neoplasia          
Kreuter 2004 [2] 3x/w x 16w 100C    
Wieland 2006 [28] 3x/w x 16w 14P, 61C    
Penile intraepithelial neoplasia          
Dirschka 2006 [1] qd x 12w      
Erythroplasia of Queyrat          
Micali 2006 [1] 3x/w x 4w, 2x/w x 4w 100C 100% 6m  
Bowenoid papulosis          
Richter 2003 [1] 3x/w x 14w 100P 100% 18m  
Goorney 2004 [1] q2d x 2m 100C 100%  
Ruocco 2004 [1] 3x/w x 8w 100P    
Godfrey 2003 [1] q2d x 3m 100C 100% 1yr With podophylin 25%
Loo 2003 [1] qhs x 12w 100C    
Petrow 2001 [1] q2d x 10d, qd x 10d 100C 100% 18m  
Cutaneous extramammary Paget’s disease          
Cohen 2006 [1] 3x/w x 16w      
Squamous cell carcinoma          
Pehoushek 2001 [1] qhs x 16w 100C 100% 3m With fluorouracil
Martin-Garcia 2005 [1] 5x/w x 12w 100C    
Fernandez2005 [1] qd x 12w 100C 100% 1yr  
Schroeder 2006 [1] qd x 11d, qd x 13d 100C 100% 18m  
Keratoacanthoma          
Dendorfer 2003 [4] q2d x 4-12w      
Di Lernia 2004 [2] 3-5x/w x 8w 100C 100% 1yr  
Denkler 2006 [1] qd x 3d, q2d x 12d 100C    
Verrucous carcinoma          
  Schalock 2006 [2] qd x 10m, qd x 30m 50C   With interferon alfa
Actinic cheilitis          
Smith 2002 [15] 3x/w x 4-6w 100C 100% 4w  
Precancerous and cancerous lesions of chronic arsenicism          
Boonchai 2006 [1] qd x 4w, 3-5x/w x 4w 100C 100% 2yr  
Intraepidermal Carcinoma          
Hengge 2001 [2] 3x/w x 17w, 3x/w x 9w 100C 100% 15m; 100% 17m  
Infiltrative trichilemmal carcinoma          
  Jo 2005 [1]   100C    
Nodular BCC          
Wu 2006 [17] qd x 6-10w      
Spencer 2006 [10]* qd x 1m 10P, 90C    
Blasi 2005 [2] 3x/w x 8-12w 100C 100% 1yr  
Cutaneous T-cell Lymphoma          
Didona 2004 [2] 3x/w x 6w 100C 100% 8m  
Suchin 2002 [1] qhs x 4m 100P 100% 10m  
Coors 2006 [8]   25P, 25C    
Lymphomatous skin deposits in chronic lymphocytic leukemia          
  Spaner 2005 [1] qd x 6w 100C 100% 10m  
Angiolymphoid hyperplasia          
Redondo 2004 [1] 5x/w x 16w 100C 100% 4m  
Lymphomatoid papulosis          
  Hughes 2006 [1] 3x/w x 4w 100C 100% 2w  
Mycosis fungoides          
Deeths 2005 [6] 3x/w x 12w 75C, 25P 66% 2yr  
Soler-Machin 2006 [1] 3x/w x 5m 100C 100% 5m  
Ariffin 2006 [1] 2x/w x 2w, qd x 4w 100C 100% 6m  
Adult cutaneous Langerhans cell histiocytosis          
  Taverna 2006 [1] 5x/w x 2m 100C 100% 6m  
Kaposi's sarcoma          
Rosen 2006 [1] qd x 4m 100C 100% 6m  
Breast cancer          
  Hengge 2005 [2] 5x/w x 6m 100C    
Herpes simplex virus 2          
  Gilbert 2001 [1] 3x/w x 1w 100P 100% 1m  
  Danielsen 2002 [1]   100C    
Herpes labialis          
Bernstein 2005 [30]* 3x/w x 1w      
Recurrent, acyclovir-resistant genital herpes.          
Martinez 2006 [2] 2-3x/w x 2w, qid x 1m, qd x 3m 100C 100% 10-12m  
Molluscum contagiosum          
Bayerl 2003 [15] 3x/w x 16w 54P, 15C    
Ross 2004 [16] qhs x 5w 75P    
Buckley 1999 [1] 3x/w x 3m 100C 100% 5m  
Yazdani 2003 [3] bid x 6m 50C    
Barba 2001 [12] qhs x 4w 33C    
Strauss 2001 [1] 3x/w x 13w 100C 100% 5m  
Hengge 2000 [50] 5x/w x 16w      
Syed 1998 [100] * tid-5x/w x 4w      
Gardener [1] 3x/w x 6m 100C 100% 6m  
Arican 2006 [9] 3x/w x 16w 92P, 8C 100% 3m  
Common, Plantar, Flat, Subungal, and Periungal Warts          
  Goihman-Yahr 2006 [4] q2d x 1m 100C 100% 1-3yr  
Juvenile verrucae planae          
Muhlstadt 2007 [1] 2x/w x 4w 100C    
Epidermodysplasia verruciformis          
Carre 2003 [1] 3x/w x 4w 100C    
Focal epithelial hyperplasia (Heck’s)          
Maschke 2002 [1] 3x/w x 3m 100 C 100% 5m  
Papillomatosis          
Rinne 2000 [1] 3x/w x 3m 100C 100% 4m  
Human Orf (ecthyma contagiosum)          
  Erbagci 2005 [4] bid x 5-10d 100C/P    
Hyalohyphomycosis          
  Erbagci 2005 [1] qd x 30apps     With itraconazole 200mg bid
Tinea pedis          
  Stashower 2006 [1] qd x 4w, bid x 10w 100C    
Leishmaniasis          
Arevalo 2001 [12] q2d x 20d 50P, 50C 90% 6m  
Miranda-Verastegui 2005 [40]* q2d x 20d      
Porokeratosis of Mibelli          
Agarwal 2002 [1] 5x/w x 5w 100C 100% 1yr  
Harrison 2003 [1] 3x/w x 6w 100C 100% 24m  
Jain 2006 [1] 5x/w x 2w, 2x/w x 6w 100C 100% 1yr  
Stucco keratosis          
Stockfleth 2000 [1] 3x/w x 5w 100c    
Seborrheic keratosis          
Herron 2004 [2] qd x 6m, bid x 6m 100C    
Trichoepitheliomas          
  Urquhart 2005 [1] 3x/w-bid x 3yr 80C   With tretinoin
Keloids          
Uysal 2006 [9] qd x 4w 100C 72%  
Post-surgical scar cosmesis          
  Berman 2005 [20]* qhs x 4w      
Hypertrophic scars          
  Prado 2005 [15] q3d x 8w   100% 24w  
Exuberant granulation tissue          
  Lain 2005 [1] 4x/w x 7m 100C 100% 2w  
Post-face peel healing          
Prado 2005 [12] qd x 12w 100C    
Chronic radiation dermatitis          
Sachse 2006 [1] qd x 2w 100C 100% 2yr  
Silicone granuloma          
Baumann 2003 [1] bid x 2w 100C 100% 4w  
Granuloma annulare          
Kuwahara 2002 [1] 6w 100C    
Kuwahara 2003 [1] 6w 100C    
Pyogenic granuloma          
Ezzel 2006 [1] qd x 2w, q2d x 4w 100C 100% 4m  
Infantile hemangioma          
Martinez 2002 [2] 3x/w x 3m 100C 100% 7m  
Welsh 2004 [10] 5x/w x 16w 75-95C 70% 4m  
Alopecia Totalis/Universalis.          
D'Ovidio 2002 [15] 3x/w x 15w      
Discoid lupus erythematosus          
Gul 2006 [1] 3x/w x 7w 100C    
Morphea          
  Dytoc 2005 [12] 3x/w x 3m 100P 100% 6m  
Xeroderma pigmentosum          
Giannotti 2003 [1] 3x/w x 4-6w 100C 100% 6m With acitretin 20mg qd
Nagore 2003 [1] 5x/w x 6w 100P 100% 8m  
Roseeuw 2003 [2] 3x/w x 6w, 3x/w x 10w      
Weisberg 2002 [2] bid, 3x/w 100P    
Nijsten 2005 [1] 3x/w x 14m 100C    
Vitiligo          
Bong 2004 [12] 3x/w x 6w 100N    
Elastosis perforans serpiginosa          
Kelly 2006 [1] qhs x 6w, 3x/w x 4m 100C 100% 3m