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Off-label indications for imiquimod

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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, 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.


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.


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.


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.


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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