Aldara (Imiquimod) - Summary

ALDARA SUMMARY

Aldara (imiquimod 5%) Cream is an immune response modifier for topical administration. Each gram 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.

Actinic Keratosis

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

Superficial Basal Cell Carcinoma

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 efficacy of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.

External Genital Warts

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

Limitations of Use

Aldara Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations].

Unevaluated Populations

The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established.

Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions.

The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.

See all Aldara indications & dosage >>

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)

Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma [Suspended]
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.

Imiquimod Treatment of CIN Lesions [Recruiting]
Rationale: Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer. High grade CIN (CIN 2-3) is currently treated by large loop excision of the transformation zone (LLETZ). This treatment has potential complications, such as hemorrhage, infection and preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed. Imiquimod (an immunomodulator) was proven effective in the treatment of HPV-related vulvar intraepithelial neoplasia (VIN) and may also be effective in HPV-related CIN. [van Seters, 2012] However, the evidence is limited and study results are not consistent. [Grimm, 2012; Pachman, 2012; Lin, 2012] Objectives: Primary objectives: (1) to investigate the efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions and (2) to develop biomarker panels to predict spontaneous regression lesion and adequate response to imiquimod therapy. Secondary objectives: to assess side effects of imiquimod treatment and LLETZ, disease recurrence and quality of life. Hypothesis: The investigators hypothesize that spontaneous regression will occur in approximately 25% and that imiquimod will be an effective treatment modality in approximately 25-50%, adding up to approximately 50-75% of CIN lesions treated without surgical intervention. Study design: Single-centre, single blinded randomized controlled intervention trial. Study population: 210 women with a histological diagnosis of CIN2-3, equally divided over three study arms. Intervention: Patients will be randomized into one of three arms: 1. Observational arm. Patients in this group receive no treatment 20 weeks. 2. Imiquimod treatment arm. Patients in this group are treated by a 16-week regime of imiquimod 5% cream. 3. Standard treatment arm. LLETZ will be performed on patients in this group. Colposcopy with diagnostic biopsies will be performed after 10 weeks for the observational and imiquimod treatment arms. In case progressive disease, the treatment will be ended and appropriate surgical excision will be performed. Treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies. A histological biomarker panel will be developed, consisting of markers representing both host and viral factors. Main study parameters/endpoints: The primary endpoint of the study is regression-or-not of CIN2-3, defined as CIN1 or less at the colposcopy at 20 weeks.

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.

Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix [Recruiting]
OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has been recognized that these procedures can increase the risks for pre-term labor in women who still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a topical immune response modulator, has significant effects on histological regression of CIN 2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may be preferable offering similar outcomes on histological regression when compared with excision or ablation while potentially avoiding or reducing the number of surgical procedure that places them at risk for future pregnancies.

Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy [Terminated]
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

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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

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