Imiquimod (also known as its brand name Aldara) is used as a 5% cream for the topical treatment of Genital Warts.
Results have shown that Imiquimod helps to get rid of warts in about half the people who use it for four months. But one study found it didn’t help people who had HIV.
Imiquimod cream is supplied in single-use sachets. Each gram of the 5% cream contains 50 mg of imiquimod in a cream base. According to the US Center for Disease Control recommendations imiquimod 5% cream be applied by the patient once daily at bedtime, 3 times per week. The treatment area should be washed with mild soap and water 6-10 hours after the application. With more frequent applications (up to 3 times daily), the rate of success does not improve significantly. However, an increase in local adverse events, such as erythema, vesicle formation, ulceration, and excoriation may occur. The treatment is usually applied for up to 16 weeks, but is well tolerated for up to 32 weeks. This duration is longer than that of any other Genital Warts treatment.
Imiquimod can also help to reduce the chance of the warts coming back two to four months after you stop using it. It doesn’t seem to matter whether you use imiquimod once, twice or three times a day. It’s just as likely to work however often you use it.
Imiquimod cream can make your skin red, swollen and itchy. Using it twice a day causes more side effects than using it less often.
You shouldn’t use imiquimod if you’re pregnant.
New warts may develop during therapy, as imiquimod is not considered a cure. Recurrences appear in up to 20 % of patients. The safety of imiquimod during pregnancy is not established and thus its use is contraindicated in pregnancy.
The side effects of imiquimod are generally mild or moderate. Erythema, erosion, swelling, changes in skin color, itching, burning, pain/ tenderness, thickening/ hardening of the skin, peeling/ flaking/ scabbing/ crusting may occur with this treatment. In some few cases in which the skin reaction is severe (bleeding, formation of sores/ blisters/ ulcers), imiquimod may need to be temporarily stopped so that the skin can heal. Other side effects may include headache, loss of appetite, dizziness, diarrhea, nausea or back pain.
Imiquimod acts by stimulating a cell-mediated response against human pappiloma virus.
Efficacy and Recurrence
Several randomized controlled trials demonstrated that imiquimod 5% cream is an efficacious treatment for external anogenital warts when applied 3 times per week for up to 16 weeks. Complete clearance of warts occurred in up to 50% of patients, and recurrence rates ranged from up to 19% after 3 months and 23% after 6 months (Garland SM, 2001). Because the recurrence rates were similar at both 3- and 6-month follow-up, it appears that after 3 months, the risk of developing recurrence is low (Vexiau D, 2005). Similar results have been reported by other studies as well.
In a prospective, double-blind, placebo-controlled, clinical trial with 108 patients, imiquimod 5% cream was applied 3 times daily for up to 8 weeks. Complete wart clearance was achieved in 37% of the imiquimod treated patients and 0% of the placebo group. A 50% reduction in baseline wart area was noted in 76% of imiquimod-treated patients compared with 8% of the placebo group. For patients whose warts cleared completely, 19% experienced recurrences after a 10-week follow-up period. Side effects were predominantly mild or moderate in severity and included itching (54%), erythema (33%), burning (31%), irritation (17%), tenderness (13%), ulceration (10%), erosion (10%), and pain (8%) (Beutner, 1998).
Imiquimod 1% or 5% significantly increased the proportion of people with complete clearance and no recurrence at 10–16 weeks after treatment compared with placebo (Moore RA, 2001). In patients whose warts completely cleared, recurrence during the 10–16 weeks after the end of the treatment was similar with imiquimod 1% and placebo, but higher with imiquimod 5%.
Another study has found that imiquimod 5% cream (3 times a week for 12 weeks) significantly increased the proportion of patients with completely healed or improved genital warts compared with placebo, regardless of gender, initial wart size, duration of current outbreak of warts, previous wart treatment, and smoking status (Syed TA, 2000).
An open-label phase IIIB trial consisting of 943 patients recruited in 20 countries, imiquimod 5% cream was found to be 47.8% effective for overall complete clearance after 16 weeks of treatment. Recurrence rates at the end of 3- and 6-month follow-up were 8.8% and 23%, respectively. The sustained clearance rates after 3 and 6 months were 41.6% and 33%, respectively. The study also found that a greater proportion of female patients (75.5%) experienced complete clearance than did male patients (56.9%). (Garland 2001). Higher efficacy rates in female patients (71% – 77%) have also been reported by other investigators (Edwards L, 1998; Sauder DN, 2003). At least one adverse event was reported in 42% of patients; the majority of reactions were mild to moderate in severity. Local erythema was the most common local skin reaction, occurring in 67% of patients.
Another RCT consisting of 311 patients was randomized to 3 arms (109: 102: 100): imiquimod 5% cream, imiquimod 1% cream, or vehicle 3 times per week for a maximum of 16 weeks. Complete clearance of lesions was achieved in 50% of patients who received the imiquimod 5% cream, 21% of those who received imiquimod 1% cream, and 11% of those treated with the placebo. After a 3-month follow-up, the study found a recurrence rate of at least 1 wart in 13% of patients who receive imiquimod 5% cream. The complete clearance mean time ranged from 8 weeks for women to 12 weeks for men. Twelve weeks after the treatment was stopped, the recurrence rate of at least one wart was 13%. The side effects reported during this study included mild or moderate erythema, erosion, excoriation. (Edwards L, 1998).
In another prospective, multicenter, double-blind, RCT with 279 patients (Beutner KR, 1998), 94 patients used imiquimod 5% cream once-daily for up to 16 weeks. Complete wart clearance occurred in 52% of patients treated with imiquimod 5% cream, with 19% wart recurrence at a 3-month follow-up. These results were similar to those obtained with 3 applications per week. This regimen with 3 times per week treatment is preferable because it is associated with a lower rate of side effects. (Perry CM, 1999; Chang YC, 2005; Gupta AK, 2004).
Even in a lower concentration (3.75%) and applied daily for up to 8 weeks imiquimod was well tolerated and superior to placebo in a cohort of women with external anogenital warts. (Baker DA, 2011).
Longer duration of treatment seems to have no additional benefit. A one-month therapy with imiquimod 5% cream applied 3 times weekly in women with genital warts had similar efficacy to a 4-month treatment (Garland SM, 2001). The difference in complete clearance rates were not statistically significant (40% after 1 month and 51.6% after 4 months, p > 0.05).
Recent studies have found that imiquimod can be succesfully used even in children (Brandt HR, 2010; Masuko T, 2011).
However, in immunosuppressed (HIV-positive) patients it seems that imiquimod is less effective (Gilson, 1999).
Imiquimod 5% cream has had similar beneficial effects of GW as podophyllotoxin 0.5% solution. Also side effects were mild and comparable with both treatments (Komericki P, 2011).
Several studies have found that treatment with imiquimod 5% cream pre- or post surgical excision of warts resulted in a lower recurrence rate compared with surgery alone (Carrasco D, 2002; Kaspari M, 2002). Association of imiquimod to surgical treatment may provide long-term clearance of anogenital warts in patients for whom monotherapy is insufficient.
In conclusion, patient-applied imiquimod 5% cream is a first line topical treatment for anogenital warts that is both safe and efficacious. Further longer follow-up studied are needed to evaluate the efficacy and recurrence rate of different combination regimens.
Getting adequate treatment to take care of genital & venereal warts is very important. One of the products you will find out there is called Aldara. It is a type of topical cream that you will have to apply to the area for several days. Keep in mind that there is no cure for genital or venereal warts. Instead, you have to find a treatment that works well for you. Here is one that you may have heard of. Before you consider it though, get the facts.
There are many benefits to using Aldara to treat genital & venereal warts. This type of infection can be very itchy and painful. With the use of this medication, the itching and pain can be reduced. It can take action quickly and offer you relief. This particular medication is offered as a topical cream.
For those that take medications for various health concerns, that is important. They don’t want to risk the medication they take to treat genital & venereal warts to interfere with medications they take for other needs. This topical product is affordable too which is important. Not everyone has health insurance or has the money to pay for expensive prescriptions.
The use of Aldara can help to boost your immune system. This means that you are less likely to suffer from future outbreaks of genital and venereal warts. This is definitely a benefit because such breakouts can be very stressful as well as embarrassing.
There have been numerous studies with the use of Aldara. The findings are that it does work to help clear up genital and venereal warts for most individuals. These studies also so that there is very little risk involved with the use of this particular type of medication.
Cons- SIDE EFFECTS
Some individuals experience irritation in the genital area after they have used Aldara. For about 11% of users, there will be the development of some type of fungal infection. If you do experience that, you need to discontinue the use of Aldara right away. Make sure you consult with your doctor so that other forms of treatment can be considered. You will also need treatment to destroy the fungal infection.
Approximately 5% of people that use Aldara will develop symptoms that are very similar to the flu. However, most of the time they don’t make the connection. The symptoms should go away within a couple of days. If they don’t it is a good idea to consult with your doctor about alternative forms of treatment.
It is important to note that the use of Aldara is only to be for external warts. Don’t use it for anything that has developed inside of the body. It shouldn’t be used for anyone under the age of 12. You should only use it for the number of days your doctor tells you to. Applying too much or using it for too long can increase your chances of developing a very serious skin reaction.
It can take up to 16 weeks of use though to get the warts to clear up from a single outbreak. It can also be difficult to remember when to apply it since it should only be applied three times per week.
Consult with your Doctor
Never use Aldara for genital or venereal warts without first talking to your doctor. It isn’t a good idea to use a prescription medication given to someone else. Don’t be embarrassed to talk to your doctor about the situation and the use of this medication. Understanding the pros and cons of Aldara can help you to decide if it is a type of medication you are willing to try or not.
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