What is the recommended dosing regimen for Aldara (imiquimod) 5% cream in a patient with actinic keratosis?

Aldara (Imiquimod 5% Cream) Dosing for Actinic Keratosis

For actinic keratosis on the face or scalp, apply Aldara (imiquimod 5% cream) at night 3 times per week for 4 weeks, which can be repeated for an additional 4 weeks if needed, washing off after 8 hours. 1, 2

Licensed Dosing Regimen

• Application frequency: 3 times per week (not consecutive days) 1
• Duration: 4-week course, repeatable for another 4 weeks if clearance is incomplete 1, 2
• Application timing: Apply at night and wash off with mild soap and water after 8 hours 1, 2
• Maximum treatment period: Do not extend beyond 16 weeks total due to missed doses or rest periods 2

Indication-Specific Requirements

Only use for:

• Non-hyperkeratotic, non-hypertrophic actinic keratoses 1
• Face or scalp locations in immunocompetent adults 1
• When cryotherapy is limited by lesion size/number or other topical options are contraindicated 1

Evidence-Based Efficacy

The British Association of Dermatologists guidelines (strength of recommendation A, level of evidence 1++) demonstrate that this licensed regimen achieves comparable efficacy to longer protocols: 1

• Complete clearance rates: 48-57% with the 3 times weekly for 16 weeks regimen 1
• Long-term durability: 76% of patients maintained clearance at 12 months, superior to 5-FU (33%) and cryosurgery (1%) 1
• Sustained benefit: 75% remained clear at 16 months with 3 times weekly for 8 weeks 1

Alternative Dosing Regimens (Off-Label)

While the licensed regimen is preferred, research supports flexibility when standard dosing causes intolerable reactions:

• Twice weekly for 16 weeks: Achieves 57% clearance but with lower long-term maintenance (57% vs 75% at 16 months) 1
• Once weekly for 24 weeks: Results in 47% marked improvement with minimal side effects, useful for patients intolerant of standard dosing 3

Critical Patient Counseling Points

Warn patients extensively before starting treatment to prevent premature discontinuation: 1

• Expected local reactions: Erythema, flaking/scaling/dryness, scabbing/crusting occur in most patients and are signs the medication is working 1, 2
• Severe reactions: 20.6-41.5% experience severe local skin reactions; treatment interruption may be necessary 1, 4
• Systemic symptoms: Flu-like illness (malaise, fever, myalgias) occurs in 3.7% of patients 1, 4, 2
• Discontinuation rates: Only 0.6-1.2% discontinue due to adverse events despite common reactions 1, 4
• Early clearance: Approximately 50% of patients discontinue at 6 weeks due to lesion disappearance 1

Application Technique

• Wash hands before and after application 2
• Apply a thin layer to the treatment area only 2
• Do not bandage or occlude the treatment area 2
• Discard partially-used packets; do not reuse 2
• Avoid contact with eyes, lips, and nostrils 2

Sun Protection Requirements

• Minimize or avoid natural/artificial sunlight exposure (including tanning beds and UVA/B treatment) during therapy 2
• Use sunscreen regularly 2

Common Pitfalls to Avoid

Do not apply to hyperkeratotic or hypertrophic lesions – these require alternative treatments like 5-FU with salicylic acid or cryotherapy first 1

Do not extend treatment beyond 16 weeks total – the FDA label explicitly prohibits this due to lack of safety data 2

Do not apply internally – vaginal application is contraindicated; this is relevant only for genital wart indication but worth noting 2