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Imiquimod

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1781. 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

1782. 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

1783. 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

1784. 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

1785. 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

1786. 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

1787. 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

1788. Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: a double-blind, randomized, vehicle-controlled study. (Abstract)

Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: a double-blind, randomized, vehicle-controlled study. Imiquimod 5% cream may provide an effective nonsurgical treatment for superficial basal cell carcinoma (sBCC) based on results of previous studies.The objective of this phase II dose-response study was to explore various dosing regimens using imiquimod 5% cream for sBCC to find the most effective frequency of dosing with tolerable side effects.Patients (n = 128) were (...) dosed twice daily, once daily, 5 times a week, or 3 times a week in this 12-week, randomized, double-blind, vehicle-controlled study. At 6 weeks after treatment, the entire tumor area was clinically evaluated, excised, and examined exhaustively for histologic evidence of residual sBCC.Complete response rates were 100% (10/10), 87.1% (27/31), 80.8% (21/26), and 51.7% (15/29) for patients in the twice daily, once daily, 5 times a week, and 3 times a week imiquimod groups, respectively, and 18.8% (6/32

2002 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

1789. Safety studies of topical imiquimod 5% cream on normal skin exposed to ultraviolet radiation. (Abstract)

Safety studies of topical imiquimod 5% cream on normal skin exposed to ultraviolet radiation. Imiquimod 5% topical cream is an immune response modifier that induces interferon alpha and interleukin-12, and exhibits antiviral and tumor-inhibiting properties. It is currently available for treatment of genital and perianal warts. Three randomized, open-label or assessor-blinded, placebo-controlled studies were carried out to assess its safety on normal white skin exposed to ultraviolet radiation (...) (UVR).Healthy white volunteer adult subjects between the ages of 18 and 60 years with skin types I, II or III (Fitzpatrick Scale, US Federal Register 43:38260, 1978) were invited to participate. Imiquimod 5% cream (each dose approximately 0.1-0.2 ml) was compared with placebo cream. Two preliminary studies assessed the potential photosensitizing properties of the drug, and the third study added measurement of sunburn cell counts (SBC) and deoxyribonucleic acid (DNA) pyrimidine dimer (PD) formation

2002 Toxicology Controlled trial quality: uncertain

1790. Imiquimod 5-percent cream does not alter the natural history of recurrent herpes genitalis: a phase II, randomized, double-blind, placebo-controlled study. Full Text available with Trip Pro

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

2002 Antimicrobial agents and chemotherapy Controlled trial quality: uncertain

1791. Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion. (Abstract)

Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion. Imiquimod 5% cream has been investigated for non-surgical treatment of superficial and nodular basal cell carcinoma (BCC) tumours.Two studies were conducted to examine the effect of occlusion at low dosing frequencies on the safety and efficacy of topical imiquimod 5% cream for the treatment of superficial and nodular BCC.Both open (...) -label studies were conducted in Europe. Patients diagnosed with BCC were enrolled into either the superficial (93 patients) or nodular (90 patients) study, depending on the histological confirmation of the patient's tumour subtype. Patients were randomized to one of four groups to apply imiquimod 5% cream 2 or 3 days per week either with or without occlusion. Six weeks following a 6-week treatment period, the entire target tumour area was excised and histologically examined for evidence of residual

2002 The British journal of dermatology Controlled trial quality: uncertain

1792. Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens. (Abstract)

Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens. To establish a safe and efficacious dosing regimen for the treatment of primary nodular basal cell carcinoma (BCC) using 5% imiquimod cream.Two phase 2 studies were conducted: a 6-week, randomized, open-label, dose-response study evaluating 4 dosing regimens and a 12-week, randomized, vehicle-controlled, double-blind, dose-response study evaluating 4 dosing regimens.Twenty (...) -four public and private dermatology clinics in Australia and New Zealand (6-week study) and the United States (12-week study) participated.The study populations comprised 99 patients enrolled in the 6-week study and 92 patients in the 12-week study. Patients were at least 18 years old and had a biopsy-confirmed diagnosis of nodular BCC.In the 6-week study, imiquimod was applied once daily for 3 or 7 days per week or twice daily for 3 or 7 days per week. In the 12-week study, imiquimod or placebo

2002 Archives of Dermatology Controlled trial quality: uncertain

1793. A randomized, double-blind, vehicle-controlled study to assess 5% imiquimod cream for the treatment of multiple actinic keratoses. (Abstract)

A randomized, double-blind, vehicle-controlled study to assess 5% imiquimod cream for the treatment of multiple actinic keratoses. Actinic keratoses (AKs) are precancerous epidermal lesions found most frequently on areas of the skin exposed to the sun. Several case studies published recently have indicated that 5% imiquimod cream, currently licensed for the treatment of genital warts, may be an effective treatment for AK.To assess the efficacy and safety of imiquimod for the treatment (...) of AK.Patients in this randomized, double-blind, vehicle-controlled study applied 5% imiquimod cream or vehicle to AK lesions 3 times per week for a maximum of 12 weeks or until lesions had resolved. In the event of an adverse reaction, application of imiquimod was reduced to 1 or 2 times per week. Rest periods were also allowed if necessary.A specialized outpatient dermatology clinic within a state-funded hospital in Germany.The study population was aged 45 to 85 years. Of 52 patients screened, 36 men

2002 Archives of Dermatology Controlled trial quality: uncertain

1794. Topical imiquimod 5% cream as an effective treatment for external genital and perianal warts in different patient populations. (Abstract)

Topical imiquimod 5% cream as an effective treatment for external genital and perianal warts in different patient populations. Genital infection with human papillomavirus, the cause of genital warts, is one of the most common sexually transmitted diseases.The aim of this analysis was to determine whether patients' demographic variables affect the efficacy of imiquimod 5% cream versus vehicle cream for the treatment of external genital and perianal warts.Male and female immunocompetent patients (...) applied imiquimod 5% cream topically to external genital warts 3 times a week until wart clearance or for up to 16 weeks.As previously published, the intent-to-treat (ITT) clearance rate was 50% (54/109) in the imiquimod-treated group and 11% (11/100) in the vehicle-treated group ( P< 0.0001). The ITT clearance rate in the imiquimod-treated group was higher in females (72%) than in males (33%). We have examined the clearance rates for subgroups based on variables of gender, baseline wart area

2003 Sexually transmitted diseases Controlled trial quality: uncertain

1795. Treatment of external genital warts in men with imiquimod 2% in cream. A placebo-controlled, double-blind study. (Abstract)

Treatment of external genital warts in men with imiquimod 2% in cream. A placebo-controlled, double-blind study. The purpose of this double-blind, placebo-controlled study was to evaluate the safety, clinical efficacy and tolerability of imiquimod (2%) in cream to cure external genital warts in males.Preselected male patients (n=60) ranging between 18 and 50 years of age (mean 24.2) harbouring 558 lesions (mean 9.3) with clinical, histopathological and polymerase chain reaction (PCR) confirmed (...) confirmed negative HPV DNA.By the end of the treatment, 40% (24/60) patients and 49.8% (278/558) warts were cured. Breaking the code revealed that imiquimod cream had cured 70% (21/30) patients and 86.8% of warts, while placebo healed three subjects and 28 warts (P=0.0001). Eleven patients (18.3%), predominantly in the imiquimod cream group, experienced mild to moderate, non-objective, drug-related side effects with no dropouts. The study was followed up for 18 months from the first day of the treatment

2000 The Journal of infection Controlled trial quality: uncertain

1796. 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

1797. 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

1798. Effect of food on the pharmacokinetics and bioavailability of oral imiquimod relative to a subcutaneous dose. (Abstract)

Effect of food on the pharmacokinetics and bioavailability of oral imiquimod relative to a subcutaneous dose. The present study, the first clinical pharmacokinetic report of the immune response modifier imiquimod, was conducted to assess the effect of food on the oral absorption of imiquimod, to characterize its pharmacokinetics, and to estimate its oral bioavailability.Sixteen healthy male volunteers completed this open-label, randomized, three-period crossover study. Subjects received a 100 (...) mg oral dose of imiquimod after fasting in one period, after a standarized, high fat meal in another, and a 30 mg subcutaneous dose in the third period.The oral bioavailability of imiquimod was on average 47%, and independent of whether imiquimod was administered with or without food. Oral imiquimod was absorbed in both fasted and non-fasted states with an absorption half-life of approximately 1 hour. However, there seemed to be a delay in the initiation of the absorption process when food

2000 International journal of clinical pharmacology and therapeutics Controlled trial quality: uncertain

1799. 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

1800. Treatment of genital herpes in males with imiquimod 1% cream: a randomised, double-blind, placebo-controlled study. (Abstract)

Treatment of genital herpes in males with imiquimod 1% cream: a randomised, double-blind, placebo-controlled study. The aim of this randomised, double-blind, placebo-controlled study was to examine the clinical significance, efficacy and tolerability of imiquimod 1% cream to manage patients exposed to first episodes of genital herpes.Male patients (n = 60), ranging in age between 18 and 50 years (mean 25.7 years), presenting for <6 days (mean 4.4 days) with culture-confirmed diagnosis (...) of genital herpes, and bearing a total of 696 lesions (mean 11.6 lesions/ patient), entered the study and were randomised to receive a precoded 40g tube and instructions on how to apply the trial medication to their lesions twice for 5 consecutive days per week.A marked clinical benefit from self-application of imiquimod 1% cream was demonstrated, resulting in both significantly shorter mean duration of healing than with the placebo (5.2 vs 14 days; p < 0.001) and more healed patients [23 of 30 (76.7

1998 Clinical drug investigation Controlled trial quality: uncertain

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