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)

Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. [2009.11]
The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod 5% cream in conjunction with the 1,064-nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser treatment alone, which is the standard for cosmetic removal of tattoos...

Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial. [2009.10]
BACKGROUND: Clinical studies in cutaneous conditions other than actinic keratosis (AK) have revealed that the safety and efficacy profile of imiquimod is influenced by dosing frequency. OBJECTIVES: To evaluate dosing frequency response of imiquimod 5% for treatment of AK... CONCLUSIONS: Imiquimod 5% applied more frequently than 3 times per week to AKs was not well tolerated. Complete clearance rates were low; however, partial clearance rates increased with increased dosing frequency (P = 0.002).

Treatment of keloid scars post-shave excision with imiquimod 5% cream: A prospective, double-blind, placebo-controlled pilot study. [2009.05]
BACKGROUND: No effective treatment exists for permanent keloid removal. When applied to excised-sites, imiquimod 5% cream reduces keloid recurrence. Case series suggest the tolerability and efficacy of imiquimod 5% application to sites of shaved keloids; however, this has not been verified in placebo-controlled studies. OBJECTIVE: To determine the tolerability and compare the efficacy of imiquimod 5% and vehicle cream in lowering keloid recurrence after shaving... CONCLUSION: Imiquimod was well tolerated. There was not enough statistical power to detect a significant difference in six-month keloid recurrence rates between the two treated groups.

Imiquimod 5% cream as adjunctive therapy for primary, solitary, nodular nasal basal cell carcinomas before Mohs micrographic surgery: a randomized, double blind, vehicle-controlled study. [2009.01]
BACKGROUND: Imiquimod 5% cream is currently approved for treatment of nonfacial, superficial basal cell carcinomas (BCCs). Topical imiquimod might be a reasonable candidate for adjunctive therapy of nodular, nasal BCCs before Mohs surgery. OBJECTIVE: To observe the effectiveness of imiquimod 5% cream in reducing the number of Mohs stages, defect size, cost of Mohs surgery, and reconstruction... CONCLUSION: Imiquimod 5% cream was not helpful as an adjunctive treatment of nodular, nasal BCCs before Mohs surgery, but a larger study might show a benefit. Clearance of nodular, nasal BCCs treated with imiquimod prior to Mohs surgery was less than described in previous studies. Nasal BCCs may be more resistant to imiquimod treatment. Local inflammatory reactions limit imiquimod's usefulness in this setting. Histologic assessment of nasal BCCs treated with imiquimod is recommended.

Placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 6 months for the treatment of actinic keratoses. [2009.01]
CONCLUSION: Imiquimod 5% cream applied once weekly for 24 weeks was convenient for patients and resulted in improvement of actinic keratoses with minimal side effects.

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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.

Aldara for the Treatment of Extensive Alopecia Areata [Completed]
We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the production of cytokines which are small, hormone-like proteins involved in cellular communication during immune responses. We hypothesize that this drug will effect the inflammatory cells present around hair follicles in patients with alopecia areata.

Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands [Completed]
The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.

Topical Imiquimod for Bowen's Disease of the Head and Neck [Enrolling by invitation]

- Double blinded, randomized, placebo controlled trial of imiquimod for the treatment of

histologically proven Bowens disease of the head and neck.

- Null hypothesis: No difference in histologic clearance rates of patients with head or

neck Bowens treated with imiquimod versus placebo.

- Outcome: Histologic clearance of Bowens disease at T=14 weeks.

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks [Enrolling by invitation]
Port wine stains (PWS) are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating PWS is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the PDL treatment is likely an important factor in why these lesions persist despite therapy.

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PATIENT REVIEWS / RATINGS / COMMENTS

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 surgery
Dosage & duration:		3 x per week (dosage frequency: 6 weeks) for the period of 6 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		aldara was used on several areas on my face where i had scar revision surgery to help heal surgical wound on face. It was prescribed by my doctor to speed up healing.
Side effects:		there was reddening, thickening of the area the medication was placed. some peeling and itching occurred at the wound treated.
Comments:		to put aldara on the surgical wounds 3 x per week for 8 hours at nite. treatment began immediately after the surgery and was used while the stitches were still in...the stitches were removed after one week and treatment with aldara continued.

Aldara review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		skin cancer
Dosage & duration:		packet , 5% cream daily (dosage frequency: nightly for 7 nights) for the period of one week
Other conditions:		none
Other drugs taken:		fexofenidine
		Reported Results
Benefits:		Aldara did seem to crust up my previous skin cancer area and help minimize my scar from MOHS surgery for skin cancer. Due to the side effects I could only tolerate for one week opposed to 6 week regiman.
Side effects:		I felt an out of it feeling, like a depressed feeling, I was fatigued and I broke out with severe blisters on and around my lips.
Comments:		I used 1/4 of a packet(5% cream) on just my nose every other night and on alternating nights I put on an entire packet on my entire face.

Aldara review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		skin cancer
Dosage & duration:		packet , 5% cream daily (dosage frequency: nightly for 7 nights) for the period of one week
Other conditions:		none
Other drugs taken:		fexofenidine
		Reported Results
Benefits:		Aldara did seem to crust up my previous skin cancer area and help minimize my scar from MOHS surgery for skin cancer. Due to the side effects I could only tolerate for one week opposed to 6 week regiman.
Side effects:		I felt an out of it feeling, like a depressed feeling, I was fatigued and I broke out with severe blisters on and around my lips.
Comments:		I used 1/4 of a packet(5% cream) on just my nose every other night and on alternating nights I put on an entire packet on my entire face.