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. As a toll-like receptor 7 agonist, it works by stimulating the local immune response, enabling the body to target and eliminate abnormal cells. This mechanism offers a non-invasive, patient-administered alternative to surgical interventions, with high clearance rates and favorable cosmetic outcomes in appropriately selected cases.

Features

• Contains 5% imiquimod as the active pharmaceutical ingredient
• Available in single-use packets (250 mg each) or multi-use pump bottles
• White-to-light-yellow oil-in-water emulsion cream formulation
• Prescription-only medication requiring proper diagnosis
• Shelf-stable at controlled room temperature (20-25°C/68-77°F)
• Compatible with normal skin care routines when applied correctly

Benefits

• Provides a non-surgical treatment option for certain skin cancers and precancerous lesions
• Stimulates the body’s own immune system to target abnormal cells selectively
• Allows convenient at-home application with prescribed dosing schedules
• Demonstrates high complete clearance rates in clinical studies when used as directed
• Typically produces superior cosmetic outcomes compared to destructive procedures
• Offers targeted therapy with minimal systemic absorption when applied properly

Common use

Aldara cream is primarily prescribed for three dermatological indications. For external genital and perianal warts (condylomata acuminata), it is applied three times per week until clearance or for up to 16 weeks. In the treatment of clinically typical, non-hyperkeratotic, non-hypertrophic actinic keratosis on the face or scalp in immunocompetent adults, it is applied twice per week for 16 weeks. For superficial basal cell carcinoma (sBCC) with a maximum diameter of 2.0 cm located on the trunk, neck, or extremities (excluding hands and feet), it is applied five times per week for 6 weeks. The medication is not indicated for internal genital warts or mucosal surfaces.

Dosage and direction

Apply a thin layer of Aldara cream to the treatment area and rub in thoroughly until the cream is no longer visible. Use the medication at bedtime and leave on the skin for approximately 8 hours before washing with mild soap and water. The amount applied should cover the treatment area with no excess extending to surrounding healthy skin. For external genital/perianal warts: apply three times per week (such as Monday, Wednesday, Friday) with at least one day 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. Always wash hands before and after application.

Precautions

Avoid contact with eyes, lips, and nostrils. Do not apply to open wounds or broken skin. Sexual contact should be avoided while the cream is on the skin as it may weaken condoms and diaphragms and may cause irritation to sexual partners. Sun exposure should be minimized during treatment, and protective clothing should be worn when outdoors. The treatment area may become unsightly during therapy due to local skin reactions. Patients should be advised that local skin reactions are common and typically indicate that the medication is working. Treatment should continue unless reactions become severe enough to potentially compromise skin integrity.

Contraindications

Aldara cream is contraindicated in patients with known hypersensitivity to imiquimod or any component of the formulation. It should not be used until completely healed from previous drug or surgical therapy. Not recommended for treatment of internal genital warts, intra-anal warts, or vaginal warts. Should not be used in patients with autoimmune disorders or those receiving immunosuppressive therapy unless benefits clearly outweigh risks. Not indicated for use in children under 12 years of age for any condition or in children 12-17 years except for external genital and perianal warts.

Possible side effect

Local skin reactions are very common and may include erythema, edema, induration, vesiculation, erosion, ulceration, flaking, scabbing, and weeping. These reactions typically peak in intensity during the third or fourth week of treatment and gradually resolve after treatment cessation. Other common reactions include itching, burning, pain, tenderness, and fatigue. Less frequently reported side effects include headache, diarrhea, back pain, fungal infections, and influenza-like symptoms. Severe local reactions may occasionally occur, requiring treatment interruption. Systemic allergic reactions are rare but may include rash, swelling, dizziness, and difficulty breathing.

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 on the efficacy and safety of concurrently administered drugs has not been established. Patients using other immunomodulators or immunosuppressive agents should be closely monitored. There is theoretical potential for interaction with vaccines, particularly those administered in the treatment area.

Missed dose

If a dose is missed, apply it as soon as remembered unless it is almost time for the next scheduled application. Do not apply two doses at the same time to make up for a missed dose. Resume the regular dosing schedule. Extended treatment duration beyond the recommended period should not be attempted without medical supervision. If multiple doses are missed, consult with the prescribing healthcare provider for guidance on how to proceed with the treatment regimen.

Overdose

Topical overdose may result in severe local skin reactions including intense erythema, swelling, and skin breakdown. Systemic overdose is unlikely due to minimal absorption through intact skin. However, if the medication is ingested orally, symptomatic and supportive care should be provided. There is no specific antidote for imiquimod overdose. In case of topical overdose, the medication should be washed off thoroughly with soap and water. Medical attention should be sought if severe local reactions occur or if accidental ingestion occurs.

Storage

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F). Do not freeze. Keep the tube or pump bottle tightly closed when not in use. Keep out of reach of children and pets. Discard any unused medication 30 days after opening the multi-use pump bottle. Single-use packets should be used immediately after opening and any unused portion discarded.

Disclaimer

This information is provided for educational purposes only and is not a substitute for professional medical advice. Always consult with a qualified healthcare provider for diagnosis and treatment recommendations. Do not initiate or alter any treatment regimen without proper medical supervision. Individual results may vary, and not all patients will experience the same outcomes. The safety and effectiveness in pediatric patients have not been established for all indications.

Reviews

Clinical studies demonstrate that Aldara cream achieves complete clearance of external genital warts in 50-60% of patients, with recurrence rates of approximately 10-20% over follow-up periods. For actinic keratosis, complete clearance rates range from 45-55% depending on the number of lesions and treatment adherence. In superficial basal cell carcinoma, histological clearance rates of 80-90% have been reported at 12 weeks post-treatment. Most patients experience local skin reactions that are generally manageable and self-limiting. Patient satisfaction surveys indicate high acceptance of the treatment despite the frequent local reactions, primarily due to the non-invasive nature and cosmetic outcomes.