Aldara® Cream (imiquimod)

Aldara® is a cream containing the active ingredient imiquimod (5%), used to treat external genital and perianal warts (condylomata acuminata, anogenital warts) in adults. These warts are caused by human papillomaviruses (HPV), usually types 6 and 11.

Imiquimod is an immunomodulator – it activates the body's own immune system to fight the viruses and cause the warts to be shed. The cream is applied by patients themselves at home.

Aldara® is also approved for the treatment of actinic keratoses and superficial basal cell carcinomas.

Mechanism of action:

• Imiquimod activates Toll-like receptor 7 (TLR7) on immune cells
• Stimulates the production of interferon-alpha and other cytokines
• The local immune response is enhanced
• Virus-infected cells are recognized and destroyed

Immunological cascade:

• Activation of dendritic cells and macrophages
• Enhanced T-cell response against HPV-infected cells
• Induces apoptosis (programmed cell death) of the wart cells
• Development of long-term immune memory

Advantages:

• Low recurrence rate (approx. 13–19%)
• Self-application at home possible
• Also treats subclinical (not visible) HPV lesions in the treatment area

Aldara® is suitable for:

• Adults with external genital and perianal warts
• Warts on normal skin (not on mucous membranes)
• Self-treatment at home

Not suitable:

• Internal (vaginal, cervical, urethral, anal) warts
• Children under 18 years of age (for this indication)
• Repeated treatment in immunosuppressed patients
• Open wounds or inflamed skin

Genital warts:

• Apply three times a week (e.g., Monday, Wednesday, Friday)
• Apply before bedtime
• Wash off after 6–10 hours
• Maximum treatment duration: 16 weeks

Amount to apply:

• Apply a thin layer to the warts
• 1 sachet is enough for an area of approx. 20 cm²
• Apply only to external warts

Course:

• First improvement after 4–8 weeks
• Complete healing after 8–16 weeks
• Redness and mild inflammation are probably a consequence of the action of imiquimod

Application: 1. Wash your hands before going to bed 2. Apply a thin layer of Aldara® to the warts 3. Rub in gently until the cream has been absorbed 4. Wash your hands thoroughly 5. The next morning (after 6–10 hours), wash off with mild soap and water

Important notes:

• Do not use under an occlusive dressing
• No sexual intercourse while the cream is on the skin
• Condoms and diaphragms may be weakened by the cream
• In case of a severe skin reaction: skip 1–2 applications
• Do not apply to open wounds or mucous membranes

Aldara® must not be used in cases of:

• Hypersensitivity to imiquimod
• Internal genital warts

Caution in cases of:

• Autoimmune diseases
• Organ transplant recipients/immunosuppressed patients
• Untreated narrowing of the foreskin (phimosis)
• Pregnancy and breastfeeding

Do not apply to:

• Mucous membranes (vaginal, inside the anus, urethral)
• Open wounds
• Sun-damaged skin at the same time

Very common (> 10%):

• Itching and pain at the application site
• Local skin reactions: redness, erosion, flaking, swelling, crusting
• These reactions are probably a consequence of the action of imiquimod

Common (1–10%):

• Burning at the application site
• Headache
• Flu-like symptoms
• Muscle pain
• Infection

Uncommon:

• Swollen lymph nodes

Note: Mild to moderate skin reactions are common. In case of severe reactions (open sores, severe pain), take a break of several days.