Aldara (imiquimod) cream is a prescription topical immunotherapy agent indicated for the treatment of certain dermatological conditions, including external genital and perianal warts, superficial basal cell carcinoma, and actinic keratosis. As a toll-like receptor 7 agonist, it functions by stimulating a localized immune response, enabling the body to target and eliminate abnormal cells. This mechanism offers a non-invasive, patient-administered treatment option with a favorable efficacy profile. It is essential that this medication is used under the supervision of a healthcare professional to ensure appropriate diagnosis, application, and monitoring.

Features

• Contains 5% imiquimod as the active pharmaceutical ingredient
• Available in single-use packets or multi-use pump dispensers, depending on indication
• Formulated as an oil-in-water emulsion cream for cutaneous application
• Requires refrigeration prior to opening; stable at room temperature after initial use
• Prescription-only medication with specific dosing regimens per indication

Benefits

• Provides a non-invasive, at-home treatment alternative to surgical procedures
• Stimulates a localized immune response to target and clear abnormal skin cells and lesions
• Demonstrates high clearance rates for approved indications with appropriate use
• Minimizes scarring risk compared to destructive treatment modalities
• Offers flexible application timing (typically applied at bedtime)
• May provide durable response and reduce recurrence rates for certain conditions

Common use

Aldara Cream is primarily prescribed for three dermatological indications. For external genital and perianal warts (condylomata acuminata), it is used in immunocompetent adults to eliminate visible warts. In the treatment of superficial basal cell carcinoma (sBCC), it is indicated for immunocompetent adults with lesions located on the trunk, neck, or extremities (excluding hands and feet), particularly when surgical methods are less appropriate. For actinic keratosis (AK), it is used on the face or scalp in immunocompetent adults. The cream works by activating immune cells in the application area, leading to the production of cytokines and subsequent destruction of abnormal tissue.

Dosage and direction

Application frequency and treatment duration vary significantly by indication:

External genital/perianal warts: Apply a thin layer to the wart area 3 times per week (e.g., Monday, Wednesday, Friday) before normal sleeping hours. Leave on the skin for 6-10 hours, then wash off with mild soap and water. Treatment continues until complete clearance or for a maximum of 16 weeks.

Superficial basal cell carcinoma: Apply 5 times per week (Monday through Friday) before bedtime for 6 weeks. The treatment area should include the tumor plus a 1 cm margin of surrounding skin. Leave on for approximately 8 hours before washing.

Actinic keratosis: Apply 2 times per week (e.g., Monday and Thursday) for 16 weeks to the entire treatment area on face or scalp. Leave on for approximately 8 hours before washing.

Use the supplied packet or pump dispenser to measure the correct amount. Wash hands before and after application. Avoid occlusive dressings unless directed by a physician.

Precautions

• For external use only; avoid contact with eyes, lips, nostrils, and mucous membranes
• Not recommended for use inside the vagina, rectum, or urethra
• Sexual contact should be avoided while the cream is on the skin
• Sun exposure should be minimized during treatment, and sunscreen should be used
• May weaken condoms and diaphragms; avoid contact with these products
• Treatment may cause local skin reactions; dosage modification may be necessary
• Use with caution in patients with autoimmune disorders or those taking immunosuppressive medications
• Not recommended for use in children under 12 years of age

Contraindications

• Hypersensitivity to imiquimod or any component of the formulation
• Patients with congenital or acquired immunodeficiencies
• Use on areas with broken skin or open wounds
• Treatment of pigmented basal cell carcinoma or morphoeic basal cell carcinoma
• Application to internal genital areas (vagina, cervix, rectum, urethra)
• Concurrent use with other topical medications in the same treatment area

Possible side effects

Most side effects are localized to the application site and typically reflect the intended immune response:

Very common (>10%):

• Application site reactions: erythema, edema, itching, burning
• Skin erosion, flaking, scabbing, and dryness
• Local pain and tenderness
• Headache, fatigue

Common (1-10%):

• Application site ulceration, bleeding, or exudate
• Skin discoloration or pigmentation changes
• Flu-like symptoms (fever, malaise, myalgia)
• Nausea, diarrhea
• Lymph node enlargement near treatment area

Rare (<1%):

• Severe skin reactions requiring treatment interruption
• Hypersensitivity reactions including angioedema
• Autoimmune disorders exacerbation
• Herpes simplex reactivation

Most local reactions peak around week 2-3 of treatment and gradually resolve after therapy completion. Systemic absorption is minimal, with most side effects being localized.

Drug interaction

Formal drug interaction studies have not been conducted, but consider the following:

• Concurrent use with other topical medications may increase irritation or affect absorption
• Avoid concomitant use with corticosteroids or other immunosuppressive agents in the treatment area
• May potentially interact with other immunomodulators
• No known interactions with systemic medications, though caution is advised with drugs that affect immune function

Missed dose

If a dose is missed, apply it as soon as remembered unless it is nearly time for the next application. Do not apply double the amount to make up for a missed dose. Resume the regular application schedule. If multiple doses are missed, consult your healthcare provider for guidance on treatment continuation.

Overdose

Excessive application may intensify local skin reactions. Systemic overdose is unlikely due to minimal absorption. If accidental ingestion occurs, seek medical attention immediately. Treatment is symptomatic and supportive. For excessive topical application, wash the area thoroughly with soap and water and monitor for severe local reactions.

Storage

• Store unopened packets or pump at 2°C-8°C (36°F-46°F); do not freeze
• After opening, the pump may be stored at room temperature (up to 25°C/77°F) for extended periods
• Protect from excessive heat and direct sunlight
• Keep out of reach of children and pets
• Discard any unused cream 30 days after opening the packet or pump

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Aldara Cream is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual results may vary. Always follow your healthcare provider’s instructions regarding use, dosage, and treatment duration. Report any severe or persistent side effects to your physician immediately.

Reviews

Clinical studies demonstrate Aldara Cream’s efficacy across its approved indications. In genital wart trials, complete clearance rates ranged from 37-52% compared to 2-5% with vehicle. For superficial basal cell carcinoma, histological clearance rates of 73-87% have been reported. Actinic keratosis studies show complete clearance in 45-55% of patients. Most patients experience local skin reactions that correlate with treatment response. Patient satisfaction surveys indicate preference for this non-invasive treatment option despite the frequent local reactions, particularly valuing the avoidance of surgical procedures and the convenience of home administration.