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Correlation between pretreatment levels of interferon response genes and clinical responses to an immune response modifier (Imiquimod) in genital warts. Imiquimod (IQ) has been successfully used in treatment of genital warts. In clinical settings, patients responded well but wart reduction rates varied. Our aim was to find a correlation between clinical responses and pretreatment (constitutive) levels of genes that might be involved in the molecular action of IQ. Since IQ is a cytokine inducer
Imiquimod 5-Percent Cream Does Not Alter the Natural History of Recurrent Herpes Genitalis: a Phase II, Randomized, Double-Blind, Placebo-Controlled Study Present strategies for control of herpes genitalis recurrences require multiple daily doses of antiviral medication. Imiquimod, an immune response modifier, induces alpha interferon and interleukin-12; application in the presence of local herpes antigens during a recurrence may augment herpes simplex virus (HSV)-specific cell-mediated (...) immunity. To test this theory, we performed a randomized, double-blind, placebo-controlled study of imiquimod 5% cream to assess safety and efficacy for decreasing recurrences. Patients with six or more recurrences of herpes genitalis per year applied study cream (imiquimod or placebo) to lesions one, two, or three times per week for 3 weeks for each recurrence during a 16-week treatment period. This was followed by a 16-week observation period. Of 124 patients randomized to the study, 103 completed
Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial. A dual-centre, randomized, double-blind, vehicle-controlled study was conducted to evaluate the safety and efficacy of short courses of therapy with imiquimod 5% cream in clearing >/=75% of baseline solar keratoses (SK) within a field of treatment. Subjects with 5-15 baseline SK within one treatment area (scalp, forehead and temples, or both cheeks) were randomized to apply imiquimod or vehicle (...) keratoses). Twenty-one out of 29 (72%) imiquimod-treated subjects cleared >/=75% of baseline lesions compared with 3/10 (30%) subjects using the vehicle cream (Fisher's exact test, P = 0.027). Imiquimod was well tolerated. The present study has a short follow-up endpoint, but suggests that imiquimod is a potential therapeutic alternative in patients with SK.
Enhancement of the innate and cellular immune response in patients with genital warts treated with topical imiquimod cream 5%. The mechanism of action of imiquimod 5% cream applied topically to patients with genital warts was evaluated in a double-blind, placebo-controlled study. Imiquimod (16 patients) or placebo (three patients) was applied three times per week for up to 16 weeks. All imiquimod-treated patients had a > or =75% reduction in total wart area while only one of three placebo (...) -treated patients had a similar reduction. Wart biopsies were taken at prestudy, week 6, and end of treatment. Polymerase chain reaction (PCR) for human papillomavirus (HPV) DNA and reverse transcriptase (RT)-PCR for messenger (m)RNAs were used to identify cytokines, cellular markers, viral gene products, and cell cycle markers in these biopsies. Treatment with imiquimod, an immune response modifier, stimulated significant increases in mRNA for interferon (IFN)-alpha, IFN-gamma and 2',5' oligoadenylate
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
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
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.
Tumor-selective induction of apoptosis and the small-molecule immune response modifier imiquimod. The incidence of nonmelanoma skin cancer, basal cell carcinomas (BCCs), and squamous cell carcinomas (SCCs) is increasing, representing a major medical and economic problem. Imiquimod, a topical small-molecule immune response modifier, has shown efficacy toward BCC and actinic keratoses in clinical trials. Imiquimod acts both indirectly, via cytokine-mediated stimulation of cellular immune (...) responses, and directly, through unknown mechanisms against tumor cells. We examined the mechanism by which imiquimod induces apoptosis in cancer cells.Apoptosis was assessed by enzyme-linked immunosorbent assay, western blot analysis, and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assays in five SCC cell lines, HaCaT cells (a spontaneously immortalized human keratinocyte cell line), and normal keratinocytes treated with imiquimod, with its analog resiquimod
Pilot study of the effect of postoperative imiquimod 5% cream on the recurrence rate of excised keloids. New adjunctive treatments are needed to reduce the high recurrence rates (50%) of excised keloids. Interferon alfa injections have been shown to decrease the size of stable keloids. This study examined the effects of postoperative imiquimod 5% cream on the recurrence of 13 keloids excised surgically from 12 patients. Starting on the night of surgery, imiquimod 5% cream was applied for 8 (...) weeks. Patients were examined at weeks 4, 8, 16, and 24 for local erythema, edema, erosions, pigment alteration, and/or recurrence of keloids. Of the 11 keloids evaluated at 24 weeks, none (0%) recurred. Incidences of hyperpigmentation were 63.6%. Two cases of mild irritation and superficial erosion cleared with temporary discontinuation of imiquimod. Both patients completed the 8 weeks of topical therapy and the final 24-week assessment. At 24 weeks, the recurrence rate of excised keloids treated
Treatment of anogenital warts with imiquimod 5% cream followed by surgical excision of residual lesions. Cytodestructive or surgical therapy for patients with anogenital warts is frequently associated with recurrence. In February 1997, the US Food and Drug Administration approved imiquimod as a 5% cream for the treatment of anogenital warts. Activity of the drug results primarily from interferon alfa and other cytokine induction in the skin. These cytokines stimulate several other aspects (...) of the innate immune response. In addition, imiquimod stimulates acquired immunity, in particular the cellular arm that is important for control of viral infections and tumors. Published studies indicate that imiquimod results in complete clearance of warts in more than 50% of patients. Residual warts can be surgically excised. Our long-term follow-up (ie, 2 to 7 years) of patients who had a 16-week course of imiquimod cream with subsequent removal of remaining warts showed a much lower rate of recurrence
Anecdotal reports of 3 cases illustrating a spectrum of resistant common warts treated with cryotherapy followed by topical imiquimod and salicylic acid. Imiquimod is an immunomodulator with indirect antiproliferative and antiviral properties known to be effective against anogenital warts. However, its use for common warts has not been validated in prospective, controlled trials. We present 3 anecdotal case reports illustrating one treatment approach for a spectrum of resistant, common warts (...) with combination therapy consisting of cryosurgery followed by administration of imiquimod and salicylic acid. The efficacy of this combined destructive and immunomodulatory therapy proved to be 50% to 100% effective after 6 to 9 weeks.
Treatment of molluscum contagiosum with imiquimod 5% cream. Molluscum contagiosum is a benign cutaneous viral disease. This article describes 5 immunocompetent patients with molluscum contagiosum who were successfully treated with imiquimod 5% cream.
Treatment of squamous cell carcinoma in situ of the penis with 5% imiquimod cream: a case report. A patient with widespread in situ squamous cell carcinoma of the glans penis was successfully managed with topical application of 5% imiquimod cream. Therapy with topical immune response modifiers may prove beneficial in cases of superficial cutaneous carcinoma and may, if future studies confirm our findings, play a role in settings in which more destructive techniques may result in cosmetic (...) defects or functional impairment. The use of imiquimod for intraepithelial squamous cell carcinoma of the anogenital area seems particularly logical because of the strong correlation between this neoplasm and infection with human papillomavirus.
Treatment of primary limited cutaneous extramammary Paget's disease with topical imiquimod monotherapy: two case reports. We present two cases of primary limited cutaneous perineal and genital extramammary Paget's disease (EMPD) that were successfully treated with imiquimod 5% cream. Clinical and histologic cure was confirmed after 7.5 to 12 weeks of monotherapy. Treatment-associated morbidity is minimal compared with more invasive therapies, and self-application by the patient improves (...) convenience and appeal. Imiquimod may offer a minimally invasive and promising therapeutic option for the treatment of limited cutaneous EMPD. The diagnosis and management of EMPD and the current literature regarding imiquimod therapy are reviewed.
Imiquimod cream in the treatment of actinic keratoses. We studied the usefulness of imiquimod cream in the treatment of 3 patients with actinic keratoses. One patient was treated 3 times per week for 4 weeks and had a marked inflammatory response with nearly complete resolution of actinic keratoses. Two subsequent patients were treated in a bilateral paired comparison study. Both patients had similar numbers of actinic keratoses on symmetric areas and treated only one side with imiquimod cream (...) 2 to 3 times per week with frequent rest periods to avoid inflammation. Both experienced marked reductions in actinic keratoses. After 8 weeks, both patients applied imiquimod cream twice per week for 9 months with continued reduction in actinic keratoses on both sides. Treatments were well tolerated. Imiquimod cream appears to be effective in the treatment of actinic keratoses. The main adverse effect is local inflammation, which can be avoided by reducing the frequency of application.
An open case series of patients with basal cell carcinoma treated with topical 5% imiquimod cream. In an open-label study we assessed the response rate and posttreatment follow-up of topical imiquimod 5% cream in 5 patients with basal cell carcinoma (BCC) who were not treated with surgical excision after topical immunotherapy. All patients received imiquimod 5% cream 3 times a week for up to 16 weeks, at which time treatment was stopped. Patients were examined at regular intervals for signs (...) of recurrence. All patients experienced resolution of their BCC. In all cases, there was a local inflammatory response during therapy, which resolved after treatment. Recurrences were not observed in any of the 5 patients during the posttreatment observation interval, which ranged from 5 to 13 months. Our experience with imiquimod 5% cream in the treatment of BCC is consistent with clinical efficacy previously reported. With the exception of one severe application site reaction, treatment was well tolerated.
Topical 5% imiquimod for the therapy of actinic cheilitis. Tissue-destructive and more selective cytotoxic therapies are the main methods used to treat actinic cheilitis. A topical immune stimulant, 5% imiquimod cream, has recently been used for treatment of cutaneous epithelial malignancies including squamous cell carcinoma in situ and basal cell carcinoma.Our aim was to review the results in patients who had been treated for actinic cheilitis with imiquimod cream.A review identified 15 (...) patients with biopsy-proven actinic cheilitis who had been treated with topical imiquimod 3 times weekly for 4 to 6 weeks. All patients with histories consistent with facial herpes simplex or documented prior facial herpes simplex eruptions were treated with oral valcyclovir, 1 g/d, during imiquimod therapy.All 15 patients showed clinical clearing of their actinic cheilitis at 4 weeks after discontinuation of the topical imiquimod. Sixty percent of the patients experienced a moderate to marked
An open label evaluation of the efficacy of imiquimod 5% cream in the treatment of recalcitrant subungual and periungual cutaneous warts. Periungual and subungual warts are very difficult to eradicate with current therapies. Most are destructive in nature (liquid nitrogen, cantharidin, vascular lesion laser) and inflammation, pain and pigment dyschromia are common side effects. Furthermore, failure to respond or appearance of new lesions often leads to even more destructive treatments (CO(2 (...) ) laser, excisional surgery) and can lead to more pain and scarring.In an open trial, the efficacy, safety, and tolerability of topical imiquimod 5% cream was assessed in 15 patients with resistant and recurrent periungual and subungual warts over a 16 week period.Twelve patients (80%) completed therapy, showing complete resolution after a mean time of three weeks (range 1-6 weeks), with the remaining three patients (20%) being classified as non-responders. Local side effects (erythema, pruritus
Clinical effect of imiquimod 5% cream in the treatment of actinic keratosis. Actinic keratosis (AK) is the earliest clinical manifestation of squamous cell carcinoma. Metastatic SCC causes the majority of the 1300 to 2300 deaths attributed to nonmelanoma skin cancer in the United States each year. Recent studies have shown that intralesional administration of interferon can be used successfully in the treatment of AK.Imiquimod is an immune response modifier, currently approved for the treatment (...) of genital warts. The topically applied immune response modifier acts by up-regulating interferon and other cytokines involved in the cell-mediated immune response at the site of application. The aim of this was to determine the efficacy and safety of imiquimod 5% cream for the treatment of AK.Twenty-two patients with AK lesions were treated with imiquimod 5% cream, initially at 3 times per week for 8 weeks, or until total clearance of lesions. Patients applied imiquimod to lesions on one side
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.