Aldara (imiquimod) Cream is a prescription topical immunomodulator indicated for the treatment of certain dermatological conditions, including external genital and perianal warts, superficial basal cell carcinoma, and actinic keratosis. It functions by stimulating the body’s local immune response to target abnormal cells, offering a non-invasive therapeutic option with a well-established efficacy and safety profile. This medication represents a significant advancement in dermatological therapeutics, providing clinicians with a valuable tool for managing specific cutaneous pathologies.

Features

• Contains 5% imiquimod as the active pharmaceutical ingredient
• Available in single-use packets or multi-use pump dispensers
• White-to-light-yellow oil-in-water emulsion formulation
• Typically supplied in 250mg single-use packets or 12.5g pump bottles
• Requires refrigeration between 2-8°C (36-46°F) for stability
• Prescription-only medication with specific dosing protocols

Benefits

• Provides a non-invasive treatment alternative to surgical procedures
• Stimulates localized immune response to target abnormal cells specifically
• Demonstrates high clearance rates for approved indications when used appropriately
• Offers convenient at-home application with professional medical supervision
• May result in less scarring compared to destructive treatment modalities
• Provides dual action through antiviral and antitumor mechanisms

Common use

Aldara Cream is primarily prescribed for three FDA-approved indications. For external genital and perianal warts (condylomata acuminata), it is applied three times per week until clearance or for a maximum of 16 weeks. In the treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratosis on the face or scalp in immunocompetent adults, it is applied twice per week for 16 weeks. For superficial basal cell carcinoma, it is applied five times per week for six weeks, limited to tumors with a maximum diameter of 2.0 cm located on the trunk, neck, or extremities (excluding hands and feet).

Dosage and direction

Application should be limited to the treatment area only. Wash hands before and after application. Apply a thin layer to the affected area and rub in until the cream is no longer visible. Do not occlude the treatment area unless directed by a healthcare provider. For external genital warts: apply three times per week (such as Monday, Wednesday, Friday) with approximately 48 hours between applications. For actinic keratosis: apply two times per week (such as Monday and Thursday) for 16 weeks. For superficial basal cell carcinoma: apply five times per week (such as Monday through Friday) for 6 weeks. The treatment area should not exceed 25 cm² for sBCC or 2.5 cm² for AK.

Precautions

Avoid contact with eyes, lips, and nostrils. Do not use on open wounds or broken skin. Sexual contact should be avoided while the cream is on the skin. This medication may weaken condoms and diaphragms. Sun exposure should be minimized during treatment. Use effective sun protection measures. Local skin reactions are common and may include erythema, edema, vesicles, erosion, ulceration, and flaking/scaling. Treatment may need to be suspended temporarily for severe skin reactions. Not recommended for use in children under 12 years of age.

Contraindications

Hypersensitivity to imiquimod or any component of the formulation. Should not be used by patients with autoimmune disorders or those undergoing immunosuppressive therapy. Contraindicated in patients with known defects in innate or adaptive immunity. Not recommended for treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papillomavirus disease. Should not be used during pregnancy unless potential benefits justify potential risks to the fetus.

Possible side effects

Very common (≥10%): application site reactions (erythema, edema, itching, burning, tenderness, pain, ulceration, erosion, flaking, scaling, crusting). Common (1-10%): headache, fatigue, fever, myalgia, influenza-like symptoms, nausea, diarrhea. Uncommon (0.1-1%): lymphadenopathy, dizziness, rash. Rare (<0.1%): severe skin reactions, hypopigmentation or hyperpigmentation, autoimmune disorders exacerbation. Systemic absorption is minimal, but systemic effects may occur particularly with larger application areas or compromised skin barrier.

Drug interaction

No formal drug interaction studies have been conducted. Theoretical interactions with other topical medications applied to the same area. Possible enhanced systemic effects when used with other immunomodulators. Caution advised with concomitant use of corticosteroids or other agents that affect immune response. May potentially interact with live vaccines due to its immunomodulatory effects.

Missed dose

Apply the missed dose as soon as remembered, unless it is almost time for the next application. Do not apply extra cream to make up for the missed dose. Resume the regular dosing schedule. Do not apply more frequently than prescribed to compensate for missed applications. If unsure about how to handle a missed dose, contact the prescribing healthcare provider for guidance.

Overdose

Excessive application may increase the severity of local skin reactions and potentially increase systemic exposure. Symptoms may include severe local reactions, flu-like symptoms, and fatigue. Treatment should be symptomatic and supportive. Remove cream by washing the area with mild soap and water. In case of accidental ingestion, seek immediate medical attention. Gastrointestinal irritation may occur following ingestion.

Storage

Store between 2°C and 8°C (36°F and 46°F). Do not freeze. Keep in original container. Keep out of reach of children. Discard any unused cream 30 days after opening the single-use packet or multi-use container. Do not use after the expiration date printed on the packaging. Protect from excessive heat and direct sunlight.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for diagnosis and treatment recommendations. Individual results may vary. Proper diagnosis and supervision by a medical professional are essential before using this medication. The full prescribing information should be reviewed before initiation of therapy.

Reviews

Clinical studies demonstrate complete clearance rates of 50-75% for external genital warts, with recurrence rates of 13-19% over follow-up periods. For actinic keratosis, complete clearance rates of 45-57% have been observed. In superficial basal cell carcinoma, histological clearance rates of 82% have been reported. Patient satisfaction surveys indicate high acceptability despite frequent local skin reactions, with most patients completing prescribed treatment courses. Long-term follow-up studies show sustained efficacy for approved indications.