What are the topical immunotherapy agents?

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Last updated: February 16, 2025View editorial policy

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From the Guidelines

Immunotherapy topical agents are utilized to treat various skin conditions, including actinic keratosis and superficial basal cell carcinoma. The most commonly used topical immunotherapy agents include imiquimod (5% cream, applied 3 times a week for 16 weeks) 1, ingenol mebutate (0.015% or 0.05% gel, applied once daily for 2-3 days) 1, and diclofenac sodium (3% gel, applied twice daily for 60-90 days) 1. These agents work by stimulating the immune system to recognize and target abnormal cells, promoting a localized immune response to eradicate the disease.

  • Imiquimod is a topical immune modulator deemed safe for use in the transplant population with no adverse effects of systemic immune activation leading to subsequent organ rejection 1.
  • Ingenol mebutate is the newest available agent, demonstrating AK clearance rates of up to 34–42% but has yet to be fully evaluated in certain populations 1.
  • Diclofenac sodium is another topical immunotherapy agent used to treat actinic keratosis, with a 41% clearance of AK in OTR 1. Treatment duration and frequency may vary depending on the specific condition and agent used, as seen in the various studies 1.

From the FDA Drug Label

1.1 Actinic Keratosis Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

  1. 2 Superficial Basal Cell Carcinoma Imiquimod Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2. 0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured
  2. 3 External Genital Warts Imiquimod Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old and older.

The topical immunotherapy agent is Imiquimod Cream 2.

  • Indications include:
    • Actinic keratosis
    • Superficial basal cell carcinoma
    • External genital warts It works by stimulating the immune system to fight off these conditions.

From the Research

Topical Immunotherapy Agents

The following are some of the topical immunotherapy agents used in the treatment of various skin conditions:

  • Imiquimod 5% cream: used for the treatment of actinic keratoses, external anogenital warts, and superficial basal cell carcinoma 3, 4, 5, 6, 7
  • Diclofenac sodium 3% gel: used for the treatment of actinic keratoses 3

Mechanism of Action

These topical immunotherapy agents work by stimulating the cutaneous immune response, which helps to clear the skin lesions. Imiquimod, for example, acts by up-regulating interferon and other cytokines involved in the cell-mediated immune response at the site of application 6.

Efficacy and Safety

The efficacy and safety of these topical immunotherapy agents have been evaluated in several studies. Imiquimod 5% cream has been shown to be effective in the treatment of actinic keratoses, with complete clearance rates ranging from 45.1% to 62.1% 5, 7. Diclofenac sodium 3% gel has also been shown to be effective, with a complete clearance rate of 19.1% 3. These agents are generally well-tolerated, with common adverse events including local skin reactions such as erythema, itching, and scabbing 3, 4, 5, 6, 7.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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