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Aldara (Imiquimod) - Summary

 
 



ALDARA SUMMARY

Aldara™ (Imiquimod) Cream, 5%

Aldara ™ is the brand name for imiquimod which is an immune response modifier. Each gram of the 5% cream contains 50 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.

Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and effectiveness of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular, morpheaform (fibrosing or sclerosing) types.

Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.


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NEWS HIGHLIGHTS

Published Studies Related to Aldara (Imiquimod)

Comparison of imiquimod 5% cream versus radiotherapy as treatment for eyelid basal cell carcinoma. [2011.10]
BACKGROUND: To compare the efficacy, cosmesis and tolerance of two non-surgical treatments-imiquimod (IMQ) 5% cream and radiotherapy (RT)-to combat periocular nodular basal cell carcinoma (BCC)... CONCLUSIONS: IMQ and RT therapies are effective for treating eyelid nodular BCCs. Cosmesis and functional results were better with IMQ, while tolerability was higher with RT.

Comparison of topical 3% diclofenac sodium gel and 5% imiquimod cream for the treatment of actinic keratoses. [2011.07]
BACKGROUND: There is a wide spectrum of treatments available for actinic keratosis (AK). Topical diclofenac sodium and imiquimod are two topical treatments, which are noninvasive, easily applied, well-tolerated and effective. AIM: To compare the effects of topical 3% diclofenac sodium plus hyaluranon (DFS) gel, 5% imiquimod (IMQ) cream, and base cream (BC) in patients with AK... CONCLUSIONS: Although DFS and IMQ each had considerable efficacy in the treatment of AK, the efficacy of DFS seemed to decrease after cessation of treatment. (c) The Author(s). CED (c) 2011 British Association of Dermatologists.

Treatment of vulvar intraepithelial neoplasia with topical imiquimod: seven years median follow-up of a randomized clinical trial. [2011.04]
OBJECTIVE: Recently we reported on the efficacy of imiquimod for treating vulvar intraepithelial neoplasia (VIN) in a placebo-controlled, double-blinded randomized clinical trial (RCT). Four weeks after treatment, a complete response was observed in 35% of patients and a partial response in 46%. All complete responders remained disease-free at 12 months follow-up. In the current investigations, we assessed long-term follow-up at least 5 years after the initial RCT... CONCLUSIONS: In case of a complete response, imiquimod is effective in the long-term. Furthermore, patients with a long-term complete response had a significantly better global quality of life than patients who recurred after imiquimod treatment. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Efficacy and safety of imiquimod versus podophyllotoxin in the treatment of anogenital warts. [2011.03]
BACKGROUND: Anogenital warts are a common sexually transmitted disease caused by human papillomaviruses. Despite the fact, that imiquimod and podophyllotoxin represent common topical agents, direct comparative studies lack. This work compares the effectiveness and safety of self-applied imiquimod 5% cream and podophyllotoxin 0.5% solution... CONCLUSIONS: The current study, a direct comparison of both, confirms the previously obtained mathematical data, that imiquimod 5% cream and podophyllotoxin 0.5% solution have an identical beneficial effect on anogenital warts and are associated with identical and acceptable side effects. Both substances constitute effective and safe treatments of untreated anogenital warts in immunocompetent individuals.

Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. [2011.02]
OBJECTIVE: Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5% cream using two two-week or three-week cycles of daily dosing... CONCLUSION: In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new) was sustained in >/= 40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.

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Clinical Trials Related to Aldara (Imiquimod)

A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy [Completed]
Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for the hemangiomas are usually restricted to more severe forms due to the risks of adverse effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological discomfort and morbidity can be caused by untreated hemangiomas, especially those in the face.

Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin conditions that benefit from modulation of the activity of the immune system, such as common warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports series have suggest that it could also be useful in hemangiomas, possibly through the inhibition of the angiogenesis by local IFN production. This is a small, open label study of 16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment (secondary outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic and predictive value of these pro-angiogenic factors in the response of hemangiomas to the treatment with Imiquimod (secondary outcome).

The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3 to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.

Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma [Recruiting]
The purpose of the study is to determine 1) the safety of administration of topical 5% imiquimod cream with or without administration of a peptide-based vaccine in patients with cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of melanoma metastasis, with or without vaccine, increases a) endothelial expression of E-selectin and b) T cell infiltration.

Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy [Recruiting]
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3. 75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone

Imiquimod 3.75% Cream in Combination With Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses [Recruiting]
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure, resulting in genetic damage and mutations, resulting in "field cancerization." Subclinical AKs may progress to clinical AKs, or even de novo invasive SCCs.

Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodessication and curettage, topical chemotherapy and light therapies. With cryotherapy, treated lesion clearance rates at 3 months post-treatment after double-freeze thaw cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at approximately 5 months post-cryosurgery has been reported to be 35-51%.

Imiquimod is a topical immune response modifier and a 5% formulation has been approved for the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also reduce subclinical lesions in the treatment area, resulting in fewer "new" AK lesions developing over the same period of time when compared to focal treatment. In a comparison of cryosurgery versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial complete clearance rates of 68 and 85% by clinical assessment, respectively. However, the treatment field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported that while application of imiquimod or vehicle following cryosurgery resulted in comparable target AK clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group had fewer total AKs and fewer subclinical AKs.

Imiquimod cream at a concentration of 3. 75% has been found in Phase 3 studies to be superior to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2) for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims to examine the benefit of cryotherapy in combination with imiquimod 3. 75% compared to cryotherapy alone.

Study Comparing Imiquimod Cream, 3.75% to Zyclara� (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis [Recruiting]
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3. 75% and Zyclara (imiquimod) Cream, 3. 75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

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Reports of Suspected Aldara (Imiquimod) Side Effects

Headache (3)Myalgia (3)Fatigue (3)Malaise (3)Dizziness (3)Thrombosis (2)Drug Ineffective (2)Pain (2)Oropharyngeal Pain (2)Pyrexia (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 7 ratings/reviews, Aldara has an overall score of 5.86. The effectiveness score is 7.43 and the side effect score is 5.43. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Aldara review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   basal cell carcinoma
Dosage & duration:   5 times per week at bedtime (dosage frequency: twice) for the period of 8 weeks each time
Other conditions:   actinic keratoses, basal cell carcinoma
Other drugs taken:   none
  
Reported Results
Benefits:   The cream made the basal cell carcinoma and actinic keratoses react, scab up, and heal to nice smooth skin after about two weeks after treatment with the cream ended.
Side effects:   I had no side effects. Some people think the ulcerated scabby areas are side effects, but this is what the cream is designed to do, make bad cells react and destruct.
Comments:   The cream is applied at bedtime for five nights a week for Basal Cell Carcinoma. Three night per week for actinic keratosis. You do this for eight weeks in a row. By the end of eight weeks, the bad cells react gradually as scabby spots. This is how you know the medicine is working. You put the cream on the spots your doctor tells you to, with about an inch margin all around it.

 

Aldara review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   scar revision
Dosage & duration:   apply to scar 3 x per week (dosage frequency: 3 x per week) for the period of 6 weeks
Other conditions:   nonr
Other drugs taken:   none
  
Reported Results
Benefits:   to help heal several facial scar revision surgical wounds to heal faster.
Side effects:   the cream caused reddening, thickening and itching at the wound site. some peeling occurred.
Comments:   put the cream on the new surgical scar immediately after surgery, while the stitches were still in. 3 x per week at nite for 8 hours. Cover with plastic type saran wrap and tape so that cream does not get wiped off or smeared. wash off thoroughly in the morning.

 

Aldara review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   bowens cancer on tip of nose
Dosage & duration:   (dosage frequency: 5 days on 2 days off) for the period of 8 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   cancer is gone
Side effects:   flu like feelings, very tired, blurred vision,then started getting really dry skin all over my face, then started getting burns all down both arms. The dermatologist did a biopsy and the results weere I have Subacute Lupis Erythematosus whish is directly related to taking this drug aldaa. My lymph nodes were swollen. It was horrible and now I am left with this lifetime crap to deal with, can't go in the sun breakout of burns are always a threat. Am sooo sorry I ever took this drug.
Comments:   I had to take this drug for 5 days and then come off of it for 2 days

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Page last updated: 2011-12-09

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