Aldara Cream

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 intended for use under the supervision of a healthcare professional who can provide appropriate diagnosis and monitoring throughout the therapy course.

Features

• Contains 5% imiquimod as the active pharmaceutical ingredient
• Available in single-use packets or multi-use tubes
• White-to-light-yellow oil-in-water emulsion cream formulation
• Supplied in 250 mg single-use packets or 5 g and 12.5 g tubes
• Requires refrigeration storage at 2°C to 8°C (36°F to 46°F)
• Manufactured under strict pharmaceutical quality control standards

Benefits

• Provides a non-surgical treatment alternative for certain skin conditions
• Stimulates the body’s own immune system to target abnormal cells
• Allows for convenient at-home application with medical supervision
• Demonstrates high clearance rates in approved indications
• May result in less scarring compared to surgical interventions
• Offers flexible dosing regimens tailored to specific conditions

Common use

Aldara cream is FDA-approved for three primary indications. For external genital and perianal warts in adults, it is applied three times per week until clearance or for up to 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 in immunocompetent adults with lesions less than 2 cm in diameter on the neck, trunk, or extremities (excluding hands and feet), it is applied five times per week for 6 weeks. Off-label uses may include treatment of molluscum contagiosum and other dermatological conditions, though such applications require careful medical consideration.

Dosage and direction

Apply a thin layer of Aldara cream to the treatment area and rub in until the cream vanishes. For genital/perianal warts: Apply before normal sleeping hours and leave on the skin for 6-10 hours, then wash off with mild soap and water. Apply three times per week (such as Monday, Wednesday, Friday) with at least one day between applications. For actinic keratosis: Apply twice 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. Wash hands before and after application. Avoid covering the treated area with occlusive dressings unless directed by a physician.

Precautions

Aldara cream may cause significant local skin reactions including erythema, edema, vesicles, erosion, ulceration, and scabbing. These reactions are generally maximal during the third or fourth week of treatment. Patients should be advised that the treatment area should not be exposed to sunlight unnecessarily, and protective clothing should be worn when going outdoors. The medication may weaken condoms and diaphragms; sexual contact should be avoided while the cream is on the skin. Avoid contact with eyes, lips, and nostrils. Do not use on open wounds or broken skin. The safety and efficacy in children under 12 years have not been established for most indications.

Contraindications

Aldara cream is contraindicated in patients with known hypersensitivity to imiquimod or any component of the formulation. It should not be used until genital/perianal warts are accurately diagnosed, as treatment may worsen unrecognized malignancies. The cream is not indicated for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal human papillomavirus disease. It should not be used by patients with autoimmune disorders or those undergoing immunosuppressive therapy without careful medical supervision. Use during pregnancy should be avoided unless clearly necessary, and breastfeeding mothers should not apply the cream to the breast area.

Possible side effects

The most common side effects are local skin reactions including: application site reactions (redness, swelling, itching, burning sensation, pain), erosion, ulceration, scabbing, and flaking skin. Systemic reactions may include fatigue, fever, headache, diarrhea, nausea, vomiting, and muscle aches. Less commonly reported effects include lymph node enlargement near the treatment area, fungal infections, and herpes simplex reactivation. Severe local reactions may require treatment interruption or discontinuation. Patients should contact their healthcare provider if they experience severe skin reactions, signs of systemic allergic reaction, or any concerning symptoms.

Drug interaction

Formal drug interaction studies have not been conducted with topical imiquimod. However, concomitant use with other topical medications applied to the same area may increase skin irritation and should be avoided. The effect of Aldara cream may be reduced in patients using immunosuppressive agents. There is theoretical potential for interaction with other immune-stimulating agents, though clinical significance remains uncertain. Patients should inform their healthcare provider about all medications, including prescription, over-the-counter, and herbal products, before beginning treatment.

Missed dose

If a dose is missed, apply it as soon as remembered unless it is almost 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, contact the prescribing healthcare provider for guidance on how to resume treatment. Consistency in application is important for optimal efficacy, particularly for the treatment of superficial basal cell carcinoma where regular application is critical.

Overdose

Topical overdose may result in severe local skin reactions including intense redness, swelling, pain, and ulceration. Systemic absorption following topical application is minimal, making systemic overdose unlikely. If accidental ingestion occurs, gastric lavage and symptomatic treatment may be considered. Medical attention should be sought if a large amount is ingested or if severe local reactions develop. There is no specific antidote for imiquimod overdose; treatment should be supportive and symptomatic.

Storage

Store Aldara cream in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the tube or packets in the original carton to protect from light. Once opened, the multi-use tube may be kept at room temperature for up to one month, but should not be exposed to temperatures above 25°C (77°F). Single-use packets should be used immediately after opening and any unused portion discarded. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

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, and not all patients will experience the same outcomes. The full prescribing information should be consulted before initiating treatment. Patients should discuss their medical history, current medications, and treatment goals with their healthcare provider to determine if this medication is appropriate for their condition.

Reviews

Clinical studies demonstrate that Aldara cream achieves complete clearance in approximately 50-60% of patients with external genital warts after 16 weeks of treatment, with recurrence rates of 10-20% over follow-up periods. For actinic keratosis, complete clearance rates range from 45-55% after 16 weeks of treatment. In superficial basal cell carcinoma, histological clearance rates of 80-90% have been reported at 12 weeks post-treatment. Patient-reported outcomes indicate high satisfaction with the non-invasive nature of treatment, though local skin reactions are commonly noted as a temporary drawback during therapy. Long-term follow-up studies show sustained efficacy in responsive patients.