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Imiquimod

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1781. The Immune Response Modifier Imiquimod Requires STAT-1 for induction of Interferon, Interferon-Stimulated Genes, and Interleukin-6 Full Text available with Trip Pro

The Immune Response Modifier Imiquimod Requires STAT-1 for induction of Interferon, Interferon-Stimulated Genes, and Interleukin-6 Imiquimod is an oral inducer of interferon (IFN) and several other proinflammatory cytokines and has been successfully used topically as an antiviral agent for the treatment of genital warts. We have investigated the molecular mechanisms by which imiquimod induces the expression of IFNs, IFN-stimulated genes (ISGs), and proinflammatory cytokines in vivo, using mice (...) deficient in various components of the IFN signaling system. Mice deficient in the transcription factor interferon regulatory factor 1 (IRF-1) or in the serine/threonine protein kinase PKR responded normally to imiquimod, producing high levels of circulating IFN and induction of several ISGs. On the other hand, when mice deficient in STAT-1 were treated, a 32-fold reduction in the level of circulating IFN was observed, together with a lack of induction of 2-5 oligo adenylate synthetase (2-5 OAS) and IRF

1999 Antimicrobial Agents and Chemotherapy

1782. Effect of imiquimod on cytokine induction in first trimester trophoblasts. Full Text available with Trip Pro

Effect of imiquimod on cytokine induction in first trimester trophoblasts. Imiquimod (IQ) is used clinically for the topical treatment of external genital warts. IQ is an immune response modifier and induces the expression of interferon-alpha and other cytokines in human Peripheral Blood Monocytes (PBMC). Trophoblasts have been previously shown to express inflammatory cytokines upon lipopolysaccharide (LPS) stimulation. The objective of this study was to evaluate the ability of IQ to induce

2000 Infectious diseases in obstetrics and gynecology

1783. Imiquimod Does not Affect Shedding of Viable Chlamydiae in a Murine Model of Chlamydia trachomatis Genital Tract Infection Full Text available with Trip Pro

Imiquimod Does not Affect Shedding of Viable Chlamydiae in a Murine Model of Chlamydia trachomatis Genital Tract Infection We postulated that either oral or vaginal administration of the immune response modifier imiquimod would decrease vaginal shedding of Chlamydia trachomatis, mouse pneumonitis strain (MoPn), in a murine model.Female BALB/c mice were infected intravaginally with C. trachomatis (MoPn) and were administered imiquimod either orally (30 mg/kg) or vaginally (10 microl of 5 (...) % imiquimod cream) prior to infection and every second day after infection for a total of four doses. The course of infection was monitored by collecting cervical-vaginal swabs and isolation in HeLa 229 cell culture. To determine whether the drug affected T helper type 1 or T helper type 2 immune response polarization, immunoglobulin G (IgG) subclass antibody responses were assessed at day 56 after infection.There was no significant difference in the course of infection when imiquimod-treated mice were

2003 Infectious diseases in obstetrics and gynecology

1784. Mechanism of action of imiquimod 5% cream in the treatment of anogenital warts. (Abstract)

Mechanism of action of imiquimod 5% cream in the treatment of anogenital warts. Objective: The objective of this randomized, double-blind, placebo-controlled trial was to evaluate the mechanism of action of imiquimod cream in the treatment of anogenital warts, and to apply the findings to the results of previously conducted safety and efficacy trials.Methods: Imiquimod (16 patients) or placebo (3 patients) cream was applied 3 times a week for up to 16 weeks; cream remained on the skin overnight (...) for 8 +/- 2 hours. Wart biopsies were taken at prestudy, week 6, and the end of treatment (just prior to clearance or at week 16) and analyzed using PCR for HPV/DNA and RT-PCR for mRNA to identify cytokines, cellular markers, markers of proliferation and differentiation, and viral gene products. Efficacy was assessed based on wart area regression as documented by wart area measurements and photographs.Results: All patients enrolled in the trial had HPV type 6/11. All imiquimod-treated patients

1998 Primary care update for Ob/Gyns Controlled trial quality: uncertain

1785. Imiquimod induced regression of clinically diagnosed superficial basal cell carcinoma is associated with early infiltration by CD4 T cells and dendritic cells. (Abstract)

Imiquimod induced regression of clinically diagnosed superficial basal cell carcinoma is associated with early infiltration by CD4 T cells and dendritic cells. Imiquimod is presumed to clear basal cell carcinoma (BCC) through apoptosis mediated by cytokines and lymphocytes, with erosion often observed correlating with complete clearance. The objective was to determine the cellular immune response early in the course of treatment in order to examine whether cell mediated immunity could (...) be responsible for imiquimod mediated regression of BCC. Sixteen adults with clinically diagnosed BCC were openly assigned to 5 days per week of drug (1, 2 or 4 weeks) or placebo (2 weeks) in groups of four. No baseline biopsy was performed. Post-treatment excision specimens were examined by routine and immunohistochemical staining. Treatment was associated with the early appearance of CD4 cells, activated dendritic cells and macrophages, with later infiltration by CD8 T cells. Dendritic cells continually

2004 Clinical and experimental dermatology

1786. Immune response modification: imiquimod. (Abstract)

Immune response modification: imiquimod. Imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine and has a molecular formula of C14H16N4. It was discovered by researchers at 3M Pharmaceuticals (St Paul, MN, USA) and is the newest in a class of drugs known as immune response modifiers. Imiquimod 5% cream has been formulated for the treatment of external genital and perianal warts (condylomata acuminata) in male and female patients. Each gram of 5% cream contains 50 mg of imiquimod (...) . In preclinical studies, imiquimod induced the production of cytokines, the principal one for antiviral activity being interferon-alpha. Imiquimod does not induce direct antiviral activity, nor does it cause direct, non-specific cytolytic destruction. Preclinical studies suggest that its antiviral action results from in vivo cytokine-induced activation of the immune system. A double-blind, placebo-controlled study designed to evaluate this hypothesis has been previously presented. The results of the study

1998 The Australasian journal of dermatology

1787. Imiquimod in clinical practice. (Abstract)

Imiquimod in clinical practice. Applied topically, imiquimod induces the production of interferon-alpha plus other cytokines. Because intralesional interferon is effective in the treatment of condylomata acuminata (genital warts), topical imiquimod has also been investigated as a potential therapy for this condition. The dosing regimen found to best balance efficacy, side-effects and practicality is 5% imiquimod cream applied overnight by the patient three times weekly until warts clear, for up (...) to 16 weeks. The largest double-blind trial to examine this protocol involved 311 patients with external anogenital warts who were randomized to use imiquimod 5% cream, imiquimod 1% cream or vehicle cream. Evaluation of all patients given medication at any time showed that 50% of those who received 5% imiquimod experienced clearing of all baseline warts, as compared to 21% of those who used 1% imiquimod and 11% of those treated with vehicle. Overall, 5% imiquimod treatment was significantly more

1998 The Australasian journal of dermatology

1788. Transient effect of topical treatment of cutaneous leishmaniasis with imiquimod. (Abstract)

Transient effect of topical treatment of cutaneous leishmaniasis with imiquimod. Treatment of cutaneous leishmaniasis can be painful and protracted and cosmetic results are often unsatisfying. The immune modulator imiquimod has been reported to be suitable for the treatment of a variety of infectious skin diseases and neoplasias.We investigated the efficacy of topical application of imiquimod in the treatment of old world leishmaniasis in a placebo-controlled prospective study.Twelve patients (...) were treated with imiquimod cream using a standard protocol, i.e. topical application three times a week, and a further three served as control group.Lesions of cutaneous leishmaniasis regressed within the first 2-4 weeks in 10 of the 12 patients, whereas in two patients no change was observed. However, after 8 weeks all lesions showed progression.Our results thus demonstrate that topical application of imiquimod alone is ineffective in treating old world cutaneous leishmaniasis. Further studies

2003 International journal of dermatology

1789. Self-administered topical 5% imiquimod cream for external anogenital warts. HPV Study Group. Human PapillomaVirus. (Abstract)

Self-administered topical 5% imiquimod cream for external anogenital warts. HPV Study Group. Human PapillomaVirus. To compare the safety and effectiveness of 5% and 1% imiquimod cream with vehicle cream in the treatment of external anogenital warts.Randomized, double-blind, placebo-controlled comparison that evaluated patients for total clearance of their warts. Patients who experienced total clearance were evaluated for recurrence in a 12-week follow-up.Eleven ambulatory offices, including (...) both private physician offices and referral medical centers.Three hundred eleven healthy men and women aged 18 years or older with 2 to 50 external anogenital warts were recruited from the practices of investigators, referring physicians, and advertisements. Eighty-two additional patients were screened but did not qualify. Four patients discontinued use of the medication because of adverse effects.Five percent imiquimod (Aldara) cream, 1% imiquimod cream, or vehicle cream was applied to all

1998 Archives of Dermatology Controlled trial quality: predicted high

1790. Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts. Full Text available with Trip Pro

Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts. Genital human papillomavirus infection is one of the most common sexually transmitted diseases. Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo antiviral and antitumor effects in animal models. The present prospective, multicenter, double-blind, randomized, vehicle-controlled trial evaluated the efficacy and safety of daily patient-applied (...) imiquimod for up to 16 weeks for the treatment of external genital warts. Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline warts cleared from 49 of 94 (52%) patients treated with 5% imiquimod cream, 13 of 90 (14%) patients treated with 1% imiquimod cream, and 3 of 95 (4%) vehicle-treated patients; the differences between the groups treated with vehicle and imiquimod were significant (P < 0.0001). For subjects who completed

1998 Antimicrobial agents and chemotherapy Controlled trial quality: uncertain

1791. Treatment of genital warts with an immune-response modifier (imiquimod). (Abstract)

Treatment of genital warts with an immune-response modifier (imiquimod). Genital warts are a common sexually transmitted disease caused by human papillomavirus. Imiquimod is a novel immune-response modifier capable of inducing a variety of cytokines, including interferon alfa, tumor necrosis factor-alpha, as well as interleukins 1, 6, and 8. In animal models imiquimod has demonstrated antiviral, antitumor, and adjuvant activity. In vitro, imiquimod has no antiviral or antitumor activity.Our (...) purpose was to determine the safety and efficacy of topical imiquimod for the treatment of external genital warts.This prospective double-blind, placebo-controlled, parallel design clinical trial was performed in three outpatient centers, a public health clinic, a university-based clinic, and a private practice. One hundred eight patients with external genital warts (predominantly white men) were entered into the trial. Fifty-one patients were randomly selected to receive 5% imiquimod cream; 57

1998 Journal of the American Academy of Dermatology Controlled trial quality: predicted high

1792. Management of female genital warts with an analog of imiquimod 2% in cream: a randomized, double-blind, placebo-controlled study. (Abstract)

Management of female genital warts with an analog of imiquimod 2% in cream: a randomized, double-blind, placebo-controlled study. The purpose of this randomized, double-blind, placebo-controlled study was to determine the clinical efficacy and tolerability of an analog of imiquimod (2%)in cream to cure genital warts in women. Sixty preselected women, ranging between 18 and 45 years of age (mean 24.3) and having 411 lesions (mean 6.8) with clinical, histopathological and polymerase chain (...) % of patients and 42.8% of warts were cured. Code disclosure revealed that imiquimod cream had cured 83.3% of the treated patients and 84.3% of the tested warts, while the placebo healed one subject and four warts (p < 0.0001). Eight patients (13.3%) in the imiquimod group experienced mild to moderate, non-objective, drug-induced symptoms with no dropouts. Among the 26 cured patients, five had a relapse after 11 months. In conclusion, the data presented demonstrate that 2% imiquimod in cream with mild

1998 The Journal of dermatology Controlled trial quality: uncertain

1793. Treatment of molluscum contagiosum in males with an analog of imiquimod 1% in cream: a placebo-controlled, double-blind study. (Abstract)

Treatment of molluscum contagiosum in males with an analog of imiquimod 1% in cream: a placebo-controlled, double-blind study. The objective of this double-blind, placebo-controlled study was to evaluate in males the clinical efficacy in treating molluscum contagiosum and tolerance of an analog of imiquimod (1%) in cream. One hundred patients between 9 and 27 years of age (mean 16.3), with 733 lesions (mean 7.3), whose size ranged from 2 to 5 mm diameter (mean spot size 3.4 mm) and a biopsy (...) . A clinically and histopathologically confirmed total elimination of lesions was considered as cured. After four weeks of treatment, 49 patients and 372 lesions were cured. Breaking the code revealed that imiquimod cream had cured 82% of the patients and 86.3% of the lesions. Placebo cleared 16% of the patients and 63 of the lesions (p < 0.0001). During the treatment, 88% of the patients experienced no allergic, localized, or drug-related adverse symptoms. Twelve patients, predominantly in the imiquimod

1998 The Journal of dermatology Controlled trial quality: uncertain

1794. A randomized, controlled, molecular study of condylomata acuminata clearance during treatment with imiquimod. (Abstract)

A randomized, controlled, molecular study of condylomata acuminata clearance during treatment with imiquimod. Imiquimod, an immune response modifier, has been demonstrated to be safe and effective in the treatment of external genital and perianal warts caused by human papillomavirus (HPV). To identify the molecular mechanism(s) by which condylomata acuminata clear during topical treatment with imiquimod, wart skin biopsies were taken from patients before treatment, at treatment week 6 (...) , and at the end of treatment. Tissues were analyzed for HPV DNA and for mRNA of several cytokines and HPV gene products. Wart clearance was associated with evidence of tissue production of interferon-alpha, -beta, and -gamma and tumor necrosis factor-alpha. Regression of warts was strongly associated with a decrease in HPV DNA and in mRNA expression for both early and late viral proteins. Thus, topical imiquimod treatment of anogenital warts led to significant increases in local production of multiple

1998 The Journal of infectious diseases Controlled trial quality: uncertain

1795. Therapeutic response of basal cell carcinoma to the immune response modifier imiquimod 5% cream. (Abstract)

Therapeutic response of basal cell carcinoma to the immune response modifier imiquimod 5% cream. Basal cell carcinoma (BCC) responds to interferon therapy. Imiquimod is a cytokine and interferon inducer.This randomized, double-blind pilot trial evaluated the safety and efficacy of imiquimod 5% cream versus vehicle in the treatment of BCC.In this population of 35 patients with BCC, 24 received imiquimod 5% cream and 11 received vehicle cream in 1 of 5 dosing regimens for up to 16 weeks. Six

1999 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

1796. Enhancement of the innate and cellular immune response in patients with genital warts treated with topical imiquimod cream 5%. (Abstract)

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

1999 Antiviral research Controlled trial quality: uncertain

1797. Correlation between pretreatment levels of interferon response genes and clinical responses to an immune response modifier (Imiquimod) in genital warts. Full Text available with Trip Pro

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

2000 Antimicrobial agents and chemotherapy

1798. Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. (Abstract)

Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. Medical therapy for genital warts remains suboptimal. The topical interferon and cytokine inducer, imiquimod, has been proved effective for the treatment of external genital and perianal warts, but there is a substantial difference in the response rates between men and women. When 5% imiquimod cream is applied three times a week up to 16 weeks (...) , approximately two thirds of women treated with imiquimod achieve complete clearance of genital warts, whereas only about one third of men clear completely.This study was undertaken to determine whether more frequent application of topical imiquimod cream would improve the rate of genital wart clearance in men.A randomized treatment trial involving adult men with biopsy-proven genital warts was conducted at nine centers in the United States and Canada using four different application frequencies.Complete

2001 Sexually transmitted diseases Controlled trial quality: uncertain

1799. Safety and efficacy of imiquimod 5% cream in the treatment of penile genital warts in uncircumcised men when applied three times weekly or once per day. (Abstract)

Safety and efficacy of imiquimod 5% cream in the treatment of penile genital warts in uncircumcised men when applied three times weekly or once per day. This dose-escalation study was performed to evaluate safety and efficacy of imiquimod 5% cream in the treatment of uncircumcised men with penile warts associated with the foreskin. The cream was applied 3 times/week (n=34) or once per day (n=30) over 8+/-2 h. Imiquimod 5% cream was safe in both treatment groups. However, the 3 times/week (...) regimen was better tolerated with a lower incidence of local skin reactions. In both groups, the 2 most frequently reported local skin reactions were erythema and erosion; they were more severe with the once-daily dosing. The most frequently reported application site reactions were burning, pruritus and irritation or pain (once-daily patients only). Total clearance was achieved in 62% of the patients in the 3 times/week group and by 57% in the once-daily group. Thus, imiquimod 5% cream administered 3

2001 International journal of STD & AIDS Controlled trial quality: uncertain

1800. Imiquimod 5% cream in the treatment of superficial basal cell carcinoma: results of a multicenter 6-week dose-response trial. (Abstract)

Imiquimod 5% cream in the treatment of superficial basal cell carcinoma: results of a multicenter 6-week dose-response trial. Superficial basal cell carcinoma (sBCC) is an increasingly common tumor in fair-skinned populations throughout the world. Imiquimod, an immune response modifier that induces cytokines including interferons, has been shown in preliminary studies to have an effect when applied topically to BCC.We conducted a multicenter, randomized, open-label dose-response trial (...) of imiquimod 5% cream in the treatment of primary sBCC assessing efficacy and safety of different dose regimens.Ninety-nine patients were randomized to 6 weeks' application of imiquimod in 1 of 4 treatment regimens: twice every day, once every day, twice daily 3 times/week, once daily 3 times/week. The treatment site was excised and examined histologically 6 weeks after cessation of imiquimod.Intention-to-treat analysis revealed 100% (3/3) histologic clearance in the twice-daily regimen, 87.9% (29/33

2001 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

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