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Imiquimod

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1801. 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

1802. 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

1803. Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Imiquimod (...) (NCI) Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology Study Details Study Description Go to Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer. PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells

2002 Clinical Trials

1804. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer

Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies (...) before adding more. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00066872 Recruitment Status : Completed First Posted : August 7, 2003 Last Update Posted : September 17, 2013 Sponsor: Queen's Medical Centre

2003 Clinical Trials

1805. Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Imiquimod Cream in Treating (...) ) Study Details Study Description Go to Brief Summary: RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer. Condition or disease Intervention/treatment Phase Non-melanomatous Skin Cancer Drug: imiquimod Procedure: conventional surgery Phase 1 Detailed Description: OBJECTIVES

2004 Clinical Trials

1806. 5% imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma. (Abstract)

5% imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma. Imiquimod is an immune response modifier that up-regulates cytokines and has been shown in clinical studies to reduce or clear basal cell carcinoma tumors when applied topically.The objectives were to evaluate the efficacy of 5% imiquimod cream in treating basal cell carcinoma preceding excision by Mohs micrographic surgery and to determine (...) if reflectance-mode confocal microscopy is useful to establish the need for surgical intervention after imiquimod treatment.Subjects applied study cream to one biopsy-confirmed basal cell carcinoma tumor 5 x/week for 2, 4, or 6 weeks in this vehicle-controlled, double-blind study. Confocal microscopy was used for the 6-week treatment group to examine the target tumor area at each interval visit and immediately before Mohs micrographic surgery. After the Mohs micrographic surgery excision, the tissue

2004 Dermatologic Surgery Controlled trial quality: uncertain

1807. [Effects of imiquimod on latent human papillomavirus anal infection in HIV-infected patients]. (Abstract)

[Effects of imiquimod on latent human papillomavirus anal infection in HIV-infected patients]. High risk human papillomaviruses (HPV) have emerged as risk factors for anal carcinoma particularly in HIV-infected patients who demonstrate a high rate of anal HPV infection. Considering the relationship between the presence of anal infection and the development of neoplastic lesions, we wished to assess the capacity of imiquimod to eradicate latent HPV infection in HIV-infected patients.We conducted (...) a prospective, randomized, double-blind and vehicle controlled study. Two consecutive anal swabs were taken at 2 month intervals and only patients with two consecutive tests positive for the detection of HPV-DNA (Hybrid Capture II) were included. Patients with persistent latent HPV infection were divided into 2 groups who applied imiquimod versus vehicle during 6 weeks. HPV-DNA presence was then investigated 2 and 4 months following the onset of treatment.Among the 80 HIV-infected patients, 26 (32.5 p. 100

2004 Annales de dermatologie et de vénéréologie Controlled trial quality: uncertain

1808. Efficacy of imiquimod for the expression of Bcl-2, Ki67, p53 and basal cell carcinoma apoptosis. (Abstract)

Efficacy of imiquimod for the expression of Bcl-2, Ki67, p53 and basal cell carcinoma apoptosis. Imiquimod is a modifier of the immune response that has been proven to be an effective treatment for basal cell carcinoma (BCC). However, its mechanism of action is still unknown.To determine whether imiquimod modifies the expression of proteins such as Bcl-2, Ki67, p53 and the BCC apoptotic index.Thirty caucasian patients with primary BCCs larger than 8 mm in diameter were included in a double (...) -blind randomized clinical and immunohistochemical study which was designed in a reference university hospital. The 30 BCCs were randomized in two treatment arms between September 2001 and February 2002. Twenty-four BCCs were treated with imiquimod 5% cream and six BCCs with Aldara (3M Pharmaceuticals) excipient. Histological samples were obtained before treatment and on days 8 and 15 during the course of treatment. The BCC expression of Bcl-2, Ki67 and p53 was determined in paraffin samples

2004 The British journal of dermatology Controlled trial quality: uncertain

1809. Effectiveness of imiquimod cream 5% for treating childhood molluscum contagiosum in a double-blind, randomized pilot trial. (Abstract)

Effectiveness of imiquimod cream 5% for treating childhood molluscum contagiosum in a double-blind, randomized pilot trial. The safety and effectiveness of imiquimod cream 5% were evaluated in the treatment of molluscum contagiosum (MC) in children. Twenty-three children ranging in age from 1 to 9 years with MC infection were randomized to either imiquimod cream 5% (12 patients) or vehicle (11 patients). Parents applied study drug to patient's lesions 3 times a week for 12 weeks. Patients (...) presented to the clinic every 2 weeks until the end of study (week 12) for safety evaluation and lesion count. Local skin reactions, partial and complete clearances, and lesion counts were statistically analyzed. Partial clearance (> or = 30% clearance of lesions) at weeks 4 and 12 was noted in 58.3% (7/12) and 66.7% (8/12) of imiquimod patients and in 0% (0/11) and 18.2% (2/11) of vehicle patients (imiquimod vs vehicle: week 4, P = .0046; week 12, P = .0361). Complete clearance at week 12 was noted

2004 Cutis; cutaneous medicine for the practitioner Controlled trial quality: uncertain

1810. 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

1811. 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

1812. 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

1813. 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

1814. 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

1815. 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

1816. 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

1817. 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

1818. 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

1819. Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial. (Abstract)

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.

2003 The Australasian journal of dermatology Controlled trial quality: predicted high

1820. Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. (Abstract)

Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. The immune system plays a critical role in the development and pathogenesis of actinic keratosis (AK). Imiquimod has been shown to stimulate the cutaneous immune response and be effective for the treatment of nonmelanoma skin cancers.Two phase III, randomized, double-blind, vehicle-controlled studies evaluated the efficacy of imiquimod 5 (...) % cream compared with vehicle in the treatment of AK lesions on the face and balding scalp.A total of 436 participants at 24 centers in the United States and Canada were randomized to either imiquimod 5% or vehicle cream. Study cream was applied one time per day, 2 days per week for 16 weeks. Clearance of AK lesions was clinically assessed at an 8-week posttreatment visit.The complete clearance rate was 45.1% for the imiquimod group and 3.2% for the vehicle group. The difference in complete clearance

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

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