Safety and efficacy of multiple 16-week courses of topical imiquimod for the treatment of large areas of skin involved with actinic Keratoses

Journal of Clinical and Aesthetic Dermatology

Volumn 2, Issue 4, 2009, Pages 20-28

  del Rosso, James Q ^a   Sofen, Howard ^b   Leshin, Barry ^c   Meng, T C ^d   Kulp, James ^d   Levy, Sharon ^d  

^a VALLEY HOSPITAL MEDICAL CENTER   (United States)

^b Dermatology Associates   (United States)

^c Skin Surgery Center   (United States)

^d Graceway Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMIQUIMOD;

ACTINIC KERATOSIS; ADULT; AGED; ANATOMICAL VARIATION; ANOREXIA; ANXIETY; APPLICATION SITE BLEEDING; APPLICATION SITE INFLAMMATION; APPLICATION SITE IRRITATION; APPLICATION SITE PAIN; APPLICATION SITE PRURITUS; ARTHRALGIA; ARTICLE; CHILL; COUGHING; CREAM; DRUG CLEARANCE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; ERYTHEMA; EYE DISEASE; FATIGUE; FEMALE; HEAD; HEMOSPERMIA; HUMAN; MAJOR CLINICAL STUDY; MALE; MYALGIA; OUTPATIENT; PAIN; PANIC; PRURITUS; SCABIES; SIDE EFFECT; TREATMENT DURATION; TREATMENT WITHDRAWAL; TRUNK; WHEEZING;

EID: 77954275637     PISSN: 19412789     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

1. Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994;131:455-464.
2. Schwartz RA. Premalignant keratinocytic neoplasms. J Am Acad Dermatol. 1996;35:223-242.
3. Yantsos VA, Conrad N, Zabawski E, Cockerell CJ. Incipient intraepidermal cutaneous squamous cell carcinoma: a proposal for reclassifying and grading solar (actinic) keratoses. Semin Cutan Med Surg. 1999;18:3-14.
4. Marrot L, Meunier JR. Skin DNA photodamage and its biological consequences. J Am Acad Dermatol. 2008; 58(Suppl 2):s139-s148.
5. Aubin F. Mechanisms involved in ultraviolet light-induced immunosuppression. Eur J Dermatol. 2003;13:515-523.
6. Glogau RG. The risk of progression to invasive disease. J Am Acad Dermatol. 2000;42:s24-s25.
7. Marks R, Foley P, Goodman G, Hage BH, Selwood TS. Spontaneous remission of solar keratosis: the case for conservative management. Br J Dermatol. 1986;115:649-655.
8. Heaphy MR. The nature of solar keratosis: a critical review in historical perspective. J Am Acad Dermatol. 2000;43:138-150.
9. Dinehart SM. The treatment of actinic keratosis. J Am Acad Dermatol. 2000;42:25-28.
10. Hemmi H, Kaisho T, Sato S, et al. Small antiviral compounds activate cells via the TLR7 MyD88-dependent signaling pathway. Nat Immunol. 2002;3:196-200.
11. Gibson SJ, Lindh JM, Riter TR, et al. Plasmacytoid dendritic cells produce cytokines and mature in response to the TLR7 agonists, imiquimod and resiquimod. Cell Immunol. 2002;218:74-86.
12. Lysa B, Tartler U, Wolf R, et al. Gene expression in actinic keratoses: pharmacological modulation by imiquimod. Br J Dermatol. 2004;151:1150-1159.
13. Ooi T, Barnetson RS, Zhuang L, et al. Imiquimod-induced regression of actinic keratoses is associated with infiltration by T lymphocytes and dendritic cells: a randomized controlled trial. Br J Dermatol. 2006;154:72-78.
14. Torres A, Storey L, Anders M, et al. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007;5:7-25.
15. Lebwohl M, Dinehart S, Whiting D, et al. Imiquimod 5% cream for the treatment of actinic keratosis: results from two Phase III, randomized, double-blind, parallel group, vehicle-controlled trials. J Am Acad Dermatol. 2004; 50:714-721.
16. Guideline for Industry. The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions. ICH-E1A, March 1995.
17. ® (imiquimod cream, 5%) [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; November 2007.
18. Jorizzo J, Dinehart S, Matheson R, et al. Vehicle-controlled, double-blind, randomized study of imiquimod 5% cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head. J Am Acad Dermatol. 2007;57:265-268.
19. Alomar A, Bichel J, McRae S. Vehicle-controlled, randomized, double-blind study to assess safety and efficacy of imiquimod 5% cream applied once daily 3 days per week in one or two courses of treatment of actinic keratoses on the head. Br J Dermatol. 2007;157:133-141.