What is Aldara?
Aldara is a cream that contains the active substance imiquimod. It is available in 250 mg sachets of cream, each containing 12.5 mg of imiquimod (5%).
What is Aldara used for?
Aldara is indicated for the treatment of adult patients with the following skin conditions:
- acute external genital and perianal condylomas (warts);
- small basal cell carcinomas (a type of slowly progressing skin cancer);
- actinic keratoses on the face and skull (abnormal, precancerous thickening of the stratum corneum of the epidermis, following an "excessive exposure to sunlight) in immunocompetent patients (with fully functioning immune defenses), when other therapeutic options such as cryotherapy (therapeutic use of very low temperatures).
The medicine can only be obtained with a prescription.
How is Aldara used?
The frequency of application and the duration of treatment with Aldara depend on the type of condition that needs to be treated.
- In the treatment of genital warts, Aldara should be applied three times per week for up to 16 weeks.
- For the treatment of small basal cell carcinomas, the cream should be applied five times a week for six weeks.
- For the treatment of actinic keratosis, the cream should be applied three times a week, for one or two four-week cycles, allowing a four-week interval between cycles.
The cream should be applied to the affected area in a thin layer before bedtime, so that it remains on the skin for an adequate period of time (about eight hours) before being washed off. For more information, see the package leaflet.
How does Aldara work?
The active substance in Aldara cream, imiquimod, is an immune response modifier. This means that, to produce its effects, the substance uses the immune system, the body's natural defense system. When imiquimod is applied to the skin, it acts locally on the immune system to induce the release of cytokines, including interferon. . These substances favor the elimination of viruses that cause the formation of warts or abnormal cells in the skin, with the consequent development of skin tumors or keratoses.
How has Aldara been studied?
In all of the studies Aldara was compared with placebo (a dummy treatment with the same cream without the active substance).
- Aldara was studied in four major 16-week studies involving 923 patients with genital warts. The main measure of effectiveness was the number of patients who had complete clearance of treated warts.
- Aldara has also been studied in two studies involving 724 patients with small basal cell carcinomas, treated for six weeks, who used Aldara or placebo five times a week or every day. The main measure of effectiveness was complete elimination of tumors after 12 weeks.
- Aldara was studied in patients with actinic keratosis in two studies involving a total of 505 patients. The main measure of effectiveness was the number of patients whose keratosis had disappeared after one or two four-week treatment courses.
What benefit has Aldara shown during the studies?
In all studies Aldara was more effective than placebo.
- In the treatment of genital warts, the overall cure rate in the four main studies was 15-52% in patients treated with Aldara compared with 3-18% in patients treated with placebo.
- Analyzing the results of the two studies in patients with small basal cell carcinomas together, complete healing was seen in 66-80% of patients treated with Aldara compared with 0-3% in the placebo group. There was no difference between the two dosing regimens.
- In the two studies in subjects with actinic keratosis, complete recovery after one or two courses of treatment was recorded in 54-55% of patients treated with ALDARA compared to 15 and 2% of patients treated with placebo.
What is the risk associated with Aldara?
The most common side effects that may occur using Aldara (seen in more than 1 in 10 patients) are reactions in the area where the cream is applied (pain or itching). For the full list of side effects reported with Aldara, see the Package Leaflet.
Aldara must not be used in people who may be hypersensitive (allergic) to imiquimod or any of the other ingredients.
Why has Aldara been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara's benefits are greater than its risks for the treatment of genital and perianal external acuminate warts (Condylomata acuminata), small basal cell carcinomas and non-hypertrophic, non-hyperkeratotic actinic keratoses in immunocompetent adult patients, when other topical treatment options are contraindicated or less appropriate. The Committee therefore recommended the granting of the marketing authorization for Aldara.
Other information about Aldara:
On 18 September 1998, the European Commission granted Meda AB a "Marketing Authorization" for Aldara, valid throughout the European Union. The "Marketing Authorization" was renewed on 18 September 2008.
For the full version of Aldara's EPAR click here.
Last update of this summary: 09-2008
The information on Aldara - imiquimod published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
