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Imiquimod

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1821. Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies. (Abstract)

Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies. Imiquimod is an immune response modifier that is a Toll-like receptor 7 agonist that induces interferon and other cytokines through the innate immune system and stimulates cell-mediated immunity through T cells. Imiquimod has been shown to be efficacious as a topical treatment for basal cell carcinoma (BCC).We sought to evaluate the efficacy and safety (...) of imiquimod 5% cream compared with vehicle for treating superficial BCC (sBCC).Two identical studies were conducted. Subjects with one sBCC were dosed with imiquimod or vehicle cream once daily 5 or 7x/week for 6 weeks in these 2 randomized, double-blind, vehicle-controlled Phase III studies. The lesion site was clinically examined 12 weeks posttreatment and then excised for histological evaluation.Data from both studies were pooled. Composite clearance rates (combined clinical and histological

2004 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

1822. Imiquimod 5% cream for the treatment of actinic keratosis: results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology. (Abstract)

Imiquimod 5% cream for the treatment of actinic keratosis: results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology. Increasing evidence suggests imiquimod may be a safe therapeutic option for the treatment of actinic keratosis (AK). The diagnosis and assessment of most AK lesions is made clinically, without histologic confirmation.A phase III, randomized, double-blind, parallel group, vehicle-controlled study evaluated the efficacy of imiquimod 5 (...) % cream compared with vehicle in the treatment of AK lesions on the face and balding scalp including pretreatment and posttreatment biopsy specimens.A total of 286 patients at 18 centers in 6 European countries with histologically confirmed AK were randomized to either imiquimod 5% cream or vehicle cream. Study cream was applied once per day, 3 days per week, for 16 weeks. Clearance of AK lesions was clinically and histologically assessed at an 8-week posttreatment visit.The complete clearance rate

2004 Journal of the American Academy of Dermatology Controlled trial quality: predicted high

1823. Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study. (Abstract)

Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study. The complete treatment of anogenital warts has not been obtained with any combination of methods; therefore, new methods are still under investigation. In this study the activity and side effects of imiquimod 5% cream were investigated. The study group consisted of 23 male and 11 female volunteers and the control group of 9 male and 2 female volunteers. Patients applied the cream three (...) patients showed no alteration in the lesions. These results were statistically significantly different (p<0.01). In 15 patients in the study group, no side effects were reported; the most frequently seen side effects were erythema and erosion. In six patients that were observed for a period of six months, recurrences occurred. Imiquimod 5% cream is a topically applied medicament that should be considered as an effective and reliable medical option in the treatment of anogenital warts.

2004 The Journal of dermatology Controlled trial quality: uncertain

1824. Imiquimod treatment induces expression of opioid growth factor receptor: a novel tumor antigen induced by interferon-alpha? Full Text available with Trip Pro

Imiquimod treatment induces expression of opioid growth factor receptor: a novel tumor antigen induced by interferon-alpha? Imiquimod represents a synthetic local immune response modifier that has demonstrated efficacy in clearing basal cell carcinoma. Via interaction with Toll-like receptor 7 on immune cells, imiquimod induces local production of cytokines, such as interferon (IFN)-alpha.To more closely define and elucidate mechanisms leading to basal cell carcinoma clearance in vivo, we (...) examined gene expression profiles of skin basal cell carcinoma before and after treatment with 5% imiquimod cream (Aldara) by using high-density oligonucleotide arrays.We show that imiquimod predominantly induces genes involved in different aspects of immune response. In addition to effects on immunity, imiquimod treatment modulates the expression of genes involved in the control of apoptosis and oncogenesis. Array data indicated that imiquimod treatment induces expression of opioid growth factor

2004 Clinical Cancer Research

1825. Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study. (Abstract)

Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study. To investigate the efficacy of topical treatment with imiquimod 5% cream, an immune response modifier, in patients with vulvar intraepithelial neoplasia (VIN) 2/3.Fifteen women (aged 35-51) with histologically proven multifocal VIN 2/3 without invasion, were entered into a prospective, observational, pilot study. Imiquimod 5% cream was applied by the patient to the vulvar lesions one (...) to three times a week at night. Clinical response was analyzed by macroscopic examination and categorized as complete (CR) or partial (PR).Four patients achieved CR (27%) and nine patients, PR (60%) after 6-34 weeks of treatment. Two patients discontinued medication. CR was reached after 6, 7, 11 and 30 weeks of treatment.This pilot study showed the potential beneficial effect of imiquimod 5% cream in multifocal VIN 2/3. In contrast to current surgical treatment, imiquimod focuses on the cause of VIN

2002 Journal of Reproductive Medicine

1826. Treatment of bowenoid and basaloid vulvar intraepithelial neoplasia 2/3 with imiquimod 5% cream. (Abstract)

Treatment of bowenoid and basaloid vulvar intraepithelial neoplasia 2/3 with imiquimod 5% cream. To evaluate the effectiveness and safety of imiquimod 5% for the treatment of bowenoid and basaloid vulvar intraepithelial neoplasia (VIN) and to evaluate recurrences following treatment.Eight patients <55 years old (range, 32-51; mean, 39.7), with bowenoid or basaloid VIN 2/3 diagnosed by biopsy were treated with imiquimod 5%. Women with other types of intraepithelial neoplasia of the lower genital (...) tract, immunosuppressed women, pregnant women and women with other types of vulvar pathology were excluded. Two patients previously treated for VIN 3 (surgical resection, resection by loop electrosurgical excision procedure) had recurrences. Patients applied imiquimod cream 3 times a week until total clearance of the lesions or up to a maximum of 16 weeks. Responses were categorized as total when there was no colposcopic evidence of a lesion, partial when the lesion area diminished >50

2004 Journal of Reproductive Medicine

1827. Topically applied imiquimod inhibits vascular tumor growth in vivo. Full Text available with Trip Pro

Topically applied imiquimod inhibits vascular tumor growth in vivo. Vascular tumors occur in approximately 10% of all infants and may be associated with significant morbidity. Available therapies for vascular tumors, such as systemic corticosteroids, vincristine, and interferon-alpha, may cause toxicity, limiting their use to complicated cases. Using a mouse hemangioendothelioma model, we investigated the efficacy and mechanism of action of imiquimod, a topically applied inducer of cytokines (...) . Application of imiquimod cream, whether initiated at the time of cell inoculation or when tumors became visible, significantly decreased tumor growth and increased animal survival in comparison with control mice. Imiquimod-treated tumors showed decreased tumor cell proliferation, increased tumor apoptosis, and increased expression of tissue inhibitor of matrix metalloproteinase-1 with decreased activity of matrix metalloproteinase-9. The demonstration that local application of imiquimod inhibits vascular

2003 Journal of Investigative Dermatology

1828. Death receptor-independent apoptosis in malignant melanoma induced by the small-molecule immune response modifier imiquimod. Full Text available with Trip Pro

Death receptor-independent apoptosis in malignant melanoma induced by the small-molecule immune response modifier imiquimod. Bypassing molecular mechanisms of apoptosis deficiency may be of great utility for the successful treatment of malignant tumors. We have discovered that imiquimod, a small-molecule immunomodulator, exerts rather tumor-selective direct pro-apoptotic activity in vivo and in vitro towards cutaneous metastases of malignant melanoma, an aggressive skin tumor. This pro (...) -apoptotic activity was not detectable with resiquimod, a closely related structural analogue whose pro-inflammatory activity is even greater than that of imiquimod. Unresponsiveness of some melanoma metastases to imiquimod in vivo corresponded to resistance towards imiquimod-induced apoptosis in vivo and in vitro. At the molecular level, the pro-apoptotic activity of imiquimod was independent of membrane-bound death receptors, but depended on Bcl-2 expression as demonstrated by overexpression of Bcl-2

2004 Journal of Investigative Dermatology

1829. Imiquimod-induced interleukin-1 alpha stimulation improves barrier homeostasis in aged murine epidermis. Full Text available with Trip Pro

Imiquimod-induced interleukin-1 alpha stimulation improves barrier homeostasis in aged murine epidermis. In response to acute disruption of the permeability barrier of aged mammals there is a diminished capacity for barrier recovery, analogous to other aged organs when stressed. Acute barrier disruption increases levels of epidermal cytokines, and cytokines are known regulators of keratinocyte mitogenesis, as well as lipid synthesis in extracutaneous tissues. Underlying the sluggish barrier (...) recovery in aged skin are diminished mRNA and protein levels for the interleukin-1 cytokine family, and its receptors. To further elucidate the role of the interleukin-1 family of cytokines in the barrier repair response, cytokine production was stimulated in aged murine skin with topical imiquimod application. Imiquimod accelerated barrier recovery after acute insults to aged and young skin. These functional results correlated temporally with increased interleukin-1 alpha production in the epidermis

2004 Journal of Investigative Dermatology

1830. Medical treatment of nasal squamous papilloma with imiquimod cream. (Abstract)

Medical treatment of nasal squamous papilloma with imiquimod cream. Warts are common lesions. The prevalence and incidence of squamous papilloma of the nasal vestibulum are not known, and it is not certain how often human papilloma viruses are involved. Numerous medical or surgical treatment modalities have been reported in the literature with variable, sometimes unsatisfactory results. Imiquimod cream is a topically applied immunomodulator. It is used for warts and other skin tumours (...) on different locations of the body. We report results of six patients treated with imiquimod five per cent cream for nasal squamous papilloma.

2003 Journal of Laryngology & Otology

1831. Imiquimod to treat different cancers of the epidermis. (Abstract)

Imiquimod to treat different cancers of the epidermis. Topical immunomodulatory therapy with imiquimod has been recently used for the treatment of actinic keratoses, intraepithelial carcinoma, and small basal cell carcinoma (BCC) besides the licensed indication of extragenital warts (condyloma).We treated several patients with particular epidermal neoplasias such as squamous cell cancer (SCC) and basal cell cancer of sclerodermiform type three times per week for 4 to 12 weeks.We report several (...) novel aspects of the treatment of epidermal cancers with self-applied, nonpainful, immunomodulatory therapy. First, we treated-for the first time-two immunosuppressed renal transplant patients for invasive SCC with imiquimod. Interestingly, systemic immunosuppression did not adversely affect the response to therapy. Second, one patient with the high-risk and aggressive growth pattern of basal cell cancer (sclerodermiform histology) was cured from his disease at a particular location in the face

2003 Dermatologic Surgery

1832. Lip silicone granulomatous foreign body reaction treated with aldara (imiquimod 5%). (Abstract)

Lip silicone granulomatous foreign body reaction treated with aldara (imiquimod 5%). We report a case of a lip granulomatous reaction after injection of silicone being treated successfully with topical Aldara (Imiquimod 5%). Silicone granulomas and the inflammatory foreign body reaction that can occur are some of the complications that arise from using silicone for cosmetic enhancement. The inflammatory reaction of this patient first appeared shortly after silicone injection of both the upper (...) and lower lips. Histopathologic examination revealed a foreign body inflammatory reaction that is consistent with silicone granuloma. Although this reaction has been described extensively in the dermatologic literature as one of the disfiguring side effects of silicone injection, its treatment has plagued cosmetic dermatologists. We report the use of an immunomodulatory cream Aldara (Imiquimod 5%) to treat this type of reaction.

2003 Dermatologic Surgery

1833. Successful treatment of persistent melanoma in situ with 5% imiquimod cream. (Abstract)

Successful treatment of persistent melanoma in situ with 5% imiquimod cream. Five percent imiquimod cream, a topically applied immune response modifier with potent antiviral and antitumor activity, has been reported to be effective in the management of lentigo maligna and cutaneous metastases from melanoma.We report a case in which 5% imiquimod cream was effective in the management of a persistent melanoma in situ.Five percent imiquimod cream was applied to the affected area twice to three (...) times a week, as tolerated.After 4 months of treatment, repeated biopsies of the previously affected areas showed complete regression of the melanoma.Treatment of melanoma in situ of sun-damaged areas with 5% imiquimod cream certainly appears warranted in selected cases where surgical procedures have failed or are not feasible owing to factors such as size and/or localization of the lesion, advanced age, or deteriorated medical status of the patient. Rigorous posttreatment follow-up is mandatory

2004 Dermatologic Surgery

1834. Topical imiquimod treatment of superficial and nodular basal cell carcinomas in patients affected by basal cell nevus syndrome: a preliminary report. (Abstract)

Topical imiquimod treatment of superficial and nodular basal cell carcinomas in patients affected by basal cell nevus syndrome: a preliminary report. Imiquimod 5% cream has been shown to be effective in the treatment of superficial basal cell carcinomas (sBCCs).To evaluate the efficacy, safety and compliance of imiquimod 5% cream for the treatment of sBCCs and nodular BCCs (nBCCs) in patients affected by basal cell nevus syndrome.Three patients (two male, one female) were enrolled in the study

2002 Journal of Dermatological Treatment

1835. Imiquimod; an international update on therapeutic uses in dermatology. (Abstract)

Imiquimod; an international update on therapeutic uses in dermatology. Imiquimod, the first member of a new class of immune response modifiers, is approved for the treatment of external genital and perianal warts. The clinical effect of imiquimod stems from cytokine-induced activation of the immune system. Topical application of imiquimod elevates the production of cytokines, including the principal cytokine for antiviral activity, interferon-alpha. This is the initial event in an immunological (...) cascade resulting in the stimulation of the innate immune response as well as the cell-mediated pathway of acquired immunity. This immune modification mediates the indirect antiviral, antiproliferative and antitumor activity of imiquimod in vivo. These properties highlight the potential of imiquimod not only as an effective treatment for genital warts, but also as a treatment for other cutaneous viral infections and cutaneous neoplasms.

2002 International Journal of Dermatology

1836. Imiquimod induces complete clearance of a PUVA-resistant plaque in mycosis fungoides. (Abstract)

Imiquimod induces complete clearance of a PUVA-resistant plaque in mycosis fungoides. Imiquimod is a topical immune response modifier that binds to Toll-like receptors 7 and 8 and induces alpha-interferon. We locally applied imiquimod 5% cream (Aldara) daily for 2 weeks on a PUVA- and retinoid-resistant plaque on the face of a patient with mycosis fungoides. The diagnosis was based on clinical appearance, histology and molecular studies. Most of the disease manifestations showed a clear (...) remission during PUVA therapy combined with low-dose retinoids. However, the plaque on the face was PUVA resistant. Local imiquimod treatment resulted in the complete clearance of the plaque. The patient has now been in complete remission for 12 months.Copyright 2003 S. Karger AG, Basel

2003 Dermatology

1837. Treatment of verrucous carcinoma with imiquimod and CO2 laser ablation. (Abstract)

Treatment of verrucous carcinoma with imiquimod and CO2 laser ablation. An 82-year-old female patient presented with a large perianal hyperkeratotic tumor extending into the anal canal. Staging did not reveal any metastatic spread. Diagnosis of verrucous carcinoma or Buschke-Löwenstein tumor, respectively, was based on typical clinical and histologic features. Moreover, human papillomavirus 6b DNA sequences could be detected by PCR. Surgical excision could not be performed due to the general (...) health status of the patient; thus, alternative therapy methods were necessary. Treatment with imiquimod cream 5% (Aldara), a topical immune response modifier applied once a day and left for 12 h, led to significant partial tumor regression and clear demarcation of the tumor. The remaining tumor, now feasible for treatment with CO2 laser, was removed in two sessions in local anesthesia. In a third session, tumor parts in the anal canal were vaporized. This case demonstrates that the combination

2003 Dermatology

1838. Determination of the area of skin capable of being covered by the application of 250 mg of 5% imiquimod cream. (Abstract)

Determination of the area of skin capable of being covered by the application of 250 mg of 5% imiquimod cream. Five percent imiquimod cream is FDA-approved for the treatment of genital and perianal warts and actinic Keratosis. The manufacturer recommends that a single sachet containing 250 mg of 5% imiquimod cream (12.5 mg of imiquimod) is adequate for a single use and is sufficient to cover a wart area of up to 20 cm(2).To determine the maximal area of skin that can be evenly covered by 250 mg (...) of 5% imiquimod cream that is contained in one single-use sachet.The contents of one 250-mg single-use sachet of 5% imiquimod cream were mixed with less than 1 mg of fluorescein sodium. The cream was applied evenly onto the abdomen of two Yorkshire female pigs and onto the medial and lateral aspects of the upper left arm of a human subject. The area of application was then measured.The average area obtained on the pig skin was 196 cm(2). The area covered on the human subject was 386 cm(2).We have

2004 Dermatologic Surgery

1839. Imiquimod 5% cream for keloid management. (Abstract)

Imiquimod 5% cream for keloid management. Keloid treatment represents a therapeutic challenge. New adjuvant therapy is needed to reduce the high recurrence rate (50%) of excised keloids.To describe the method for using imiquimod 5% cream in the prevention of keloid recurrence after surgery.This is a review of the scientific rationale and clinical experience of using imiquimod 5% cream for keloid management.Topical application of imiquimod 5% cream after surgery reduces keloid recurrences.

2003 Dermatologic Surgery

1840. Topical imiquimod treatment for nodular basal cell carcinomas: an open-label series. (Abstract)

Topical imiquimod treatment for nodular basal cell carcinomas: an open-label series. Imiquimod has been used for basal cell carcinomas (BCCs). This is the first open-label series using imiquimod for nodular BCC with Mohs surgery resection for confirmation of treatment.To evaluate the efficacy of topical imiquimod in patients with biopsy-proven nodular BCC.After 12 weeks for three times a week application, treatment sites at week 15 were surgically excised using Mohs micrographic surgery. All 15

2004 Dermatologic Surgery

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