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Imiquimod

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1641. Topical imiquimod can reverse vulvar intraepithelial neoplasia: a randomised, double-blinded study. (Abstract)

Topical imiquimod can reverse vulvar intraepithelial neoplasia: a randomised, double-blinded study. To investigate the effect of topical imiquimod in patients with vulvar intraepithelial neoplasia (VIN).We used a prospective, randomised, double-blinded, placebo-controlled study. Women with biopsy verified, visible VIN2 or VIN3, in a biopsy not older than 2 months were considered.Thirty-two patients were included, one was excluded before treatment. Twenty-one received active treatment, 10 (...) received placebo. Seventeen (81%) in the treatment group showed complete response, two (10%) partial response and none responded in the placebo-group when evaluated by a biopsy 2 months after a treatment period of 16 weeks. Fourteen of 21 patients (67%) in the treatment group had to reduce the number of applications due to local side-effects.The topical treatment with imiquimod 5% was shown in this setting to be very efficient. Local side effects were a common feature, but tolerable after dose

2007 Gynecologic oncology Controlled trial quality: uncertain

1642. Comparison of the efficacy and tolerability of 3% diclofenac sodium gel and 5% imiquimod cream in the treatment of actinic keratosis. (Abstract)

Comparison of the efficacy and tolerability of 3% diclofenac sodium gel and 5% imiquimod cream in the treatment of actinic keratosis. Topical diclofenac and imiquimod have been reported to be effective in the treatment of actinic keratosis, but a study to compare these two drugs has not been reported yet.To compare the efficacy and safety of topical 3% diclofenac gel plus hyaluronic acid and 5% imiquimod cream in the treatment of actinic keratosis.Forty-nine patients with actinic keratosis were (...) enrolled in this randomized comparative open-label study. Twenty-four patients applied 3% diclofenac gel once a daily to their lesions, while the other 25 patients were treated with a 5% imiquimod cream three times a week for 12 weeks. Patients were examined before treatment and every month of the treatment. Assessments were made by investigators according to the Investigator and the Patient Global Improvement Indices (IGII) and (PGII).According to the IGII results, a complete response was observed

2008 Journal of Dermatological Treatment Controlled trial quality: uncertain

1643. Comparison of cryotherapy to imiquimod 5% in the treatment of anogenital warts. (Abstract)

Comparison of cryotherapy to imiquimod 5% in the treatment of anogenital warts. The aim of this study was to compare the efficacy of crotherapy versus imiquimod 5% in the treatment of anogenital warts. Eighty HIV-negative males were included in the analysis; 35 of them were treated with imiquimod 5% three times a week for 6-10 hours and 45 of them with cryotherapy once in three weeks. Follow-up appointments were arranged every month for the first three months and then at six and 12 months (...) , or in between whenever the patients noticed any signs of recurrence. Treatment for both groups was continued for a total of 12 weeks or until the warts cleared. At the end of three months, irrespective of the type of treatment, 78.8% of the patients demonstrated 100% improvement. Cryotherapy was more effective, as 86.7% of patients showed 100% improvement compared with 68.6% of patients in the imiquimod group. On the contrary, 17.1% of the imiquimod group did not show any signs of improvement, compared

2008 International journal of STD & AIDS Controlled trial quality: uncertain

1644. A randomized parallel study to assess the safety and efficacy of two different dosing regimens of 5% imiquimod in the treatment of superficial basal cell carcinoma. (Abstract)

A randomized parallel study to assess the safety and efficacy of two different dosing regimens of 5% imiquimod in the treatment of superficial basal cell carcinoma. This study was designed to compare the safety and efficacy of two cycled dosing regimens of imiquimod 5% cream for treatment of superficial basal cell carcinoma (sBCC).Patients (n = 32) were randomized to receive one of two treatment regimens: 8 weeks of treatment with once-daily dosing for alternate weeks (R1) and 5 weeks of once (...) %, p = 0.02). There was no difference in acceptability of treatment as measured by composite median visual analogue scores at week 8.Five weeks of 5% imiquimod cream once daily with a 1-week interval was more effective but as well tolerated as the 8-week alternate week regimen for sBCC.

2008 Journal of Dermatological Treatment Controlled trial quality: uncertain

1645. 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

1646. 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

1647. 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

1648. 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

1649. [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

1650. 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

1651. 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

1652. Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. Full Text available with Trip Pro

Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. To evaluate the efficacy and safety of 5% imiquimod cream compared with vehicle in the treatment of actinic keratosis (AK).Two phase 3 randomized, double-blind, parallel-group, vehicle-controlled studies.Twenty-six ambulatory care offices, including dermatologists in private practice or research centers.Four hundred (...) ninety-two patients, 18 years and older, with 4 to 8 AK lesions in a 25-cm(2) treatment area on the face or the balding scalp were randomized; an additional 162 patients underwent screening but were ineligible.Patients applied 5% imiquimod (Aldara) or vehicle cream to the treatment area once daily, 3 times per week, for 16 weeks, followed by an 8-week posttreatment period.Complete clearance rate (proportion of patients at the 8-week posttreatment visit with no clinically visible AK lesions

2005 Archives of Dermatology Controlled trial quality: predicted high

1653. Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru. Full Text available with Trip Pro

Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru. Current treatments for cutaneous leishmaniasis are limited by their toxicity, high cost, and discomfort and the emergence of drug resistance. New approaches, including combination therapies, are urgently needed. We performed a double-blind, randomized trial of therapy with parenteral antimony plus topical imiquimod, an innate immune-response (...) modulator, versus therapy with antimony alone, in subjects with cutaneous leishmaniasis for whom an initial course of antimony therapy had failed.Forty subjects with clinical resistance to antimony were recruited in Lima, Peru, between February 2001 and December 2002. All subjects received meglumine antimoniate (20 mg/kg/day im or iv) and were randomized to receive either topical imiquimod 5% cream (Aldara; 3M Pharmaceuticals) or vehicle control every other day for 20 days. Lesions and adverse events

2005 Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Controlled trial quality: uncertain

1654. Imiquimod treatment of superficial and nodular basal cell carcinoma: 12-week open-label trial. (Abstract)

Imiquimod treatment of superficial and nodular basal cell carcinoma: 12-week open-label trial. Imiquimod is an immune response modifier shown to be effective in basal cell carcinoma (BCC).To evaluate the efficacy, tolerability, and response durability of imiquimod 5% cream in selected patients with superficial and/or nodular BCCs.Seventy-five superficial and 19 nodular BCCs in 49 patients were treated with imiquimod once daily three times a week for up to 12 weeks.Of the 49 enrolled patients, 1 (...) was detected in 68 of 70 (97.1%) superficial BCCs and in 10 successfully treated nodular BCCs after 12 to 34 months of follow-up (mean 23 months).In our patient population, treatment of superficial BCCs with topical imiquimod for 12 weeks produced an excellent clinical response overall, with complete remission maintained after a mean of 23 months.

2005 Dermatologic Surgery

1655. Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis

Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis - 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. Oral (...) Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis 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: NCT01380314 Recruitment Status : Completed First Posted : June 27, 2011 Last Update Posted : June 27, 2011 Sponsor: Foundation Fader Information provided by: Foundation Fader Study Details Study

2008 Clinical Trials

1656. Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. (Abstract)

Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. The molecular events leading to actinic keratosis (AK) are not well understood.To identify and compare gene expression changes in AK lesions and in sun-exposed nonlesional skin and to determine the effect of imiquimod 5% cream on these changes.A double-blind, vehicle-controlled, randomized study was conducted to evaluate the molecular changes in AK treated with imiquimod (...) . Seventeen male subjects with >/= 5 AK lesions on the scalp applied vehicle or imiquimod three times a week for 4 weeks. Gene expression analysis using Affymetrix oligonucleotide arrays was performed on shave biopsies of lesions taken before and after treatment. Confocal microscopy was performed on the study area as an adjunctive diagnostic procedure.We identified gene expression changes which occur in sun-exposed, nonlesional skin as well as in AK lesions. These changes include, but are not limited

2007 The British journal of dermatology Controlled trial quality: uncertain

1657. Efficacy of imiquimod as an adjunct to cryotherapy for actinic keratoses. (Abstract)

Efficacy of imiquimod as an adjunct to cryotherapy for actinic keratoses. Cryotherapy is the standard of care for clinically apparent (target) actinic keratoses (AKs). Topical imiquimod may reduce initially inapparent or subclinical AKs.We evaluated the potential of topical imiquimod to decrease subclinical AKs after cryotherapy of target AKs.A randomized trial of imiquimod or vehicle twice weekly for 8 weeks following 3- to 5-second cryotherapy of target AKs within a 50 cm(2) field at the face (...) or scalp was conducted. Efficacy outcomes included clearance of target, subclinical, and total AKs and proportions clear of AKs. Subjects with residual AKs were offered cryotherapy and open-label imiquimod twice weekly for 8 weeks.Sixty-three subjects completed the randomized phase. At 12 weeks, target AK clearance was similar for imiquimod and vehicle (79% vs 76%), but fewer total AKs were noted for imiquimod (78 vs 116). This was due to a progressive reduction in subclinical AKs with imiquimod

2007 Journal of cutaneous medicine and surgery Controlled trial quality: uncertain

1658. Earlier eradication of intra-anal warts with argon plasma coagulator combined with imiquimod cream compared with argon plasma coagulator alone: a prospective, randomized trial. (Abstract)

Earlier eradication of intra-anal warts with argon plasma coagulator combined with imiquimod cream compared with argon plasma coagulator alone: a prospective, randomized trial. Despite the increasing incidence of condylomata acuminate, optimal treatment of anal warts is still undecided. This prospective, randomized study was designed to compare the efficacy of combined argon plasma coagulation and imiquimod cream vs. argon plasma coagulation alone in the management of intra-anal warts.From (...) October 2002 to March 2005, 49 patients with intra-anal warts were randomly assigned to argon plasma coagulation plus imiquimod cream (n = 24) vs. argon plasma coagulation alone (n = 25). Therapeutic sessions were repeated until the elimination of the warts. Efficacy of therapy was defined as the time needed for eradication. All patients were followed up for a mean period of 12 months for signs of recurrence.Elimination of warts was achieved earlier in patients receiving combination therapy compared

2007 Diseases of the colon and rectum Controlled trial quality: uncertain

1659. Imiquimod 5% cream for treatment of HIV-negative Kaposi's sarcoma skin lesions: A phase I to II, open-label trial in 17 patients. (Abstract)

Imiquimod 5% cream for treatment of HIV-negative Kaposi's sarcoma skin lesions: A phase I to II, open-label trial in 17 patients. Kaposi's sarcoma (KS), a virus-associated neoplasm, can be treated locally or systemically with interferon alfa. Therefore, imiquimod, an immune response modifier able to induce interferon-alpha secretion in situ, could prove a good local treatment for KS skin lesions.We sought to determine the efficacy and safety of imiquimod 5% cream for the topical treatment (...) of classic or endemic KS skin lesions in patients who are HIV negative.We conducted a prospective, open-label, single center, phase II clinical trial. Imiquimod cream was applied under occlusion 3 times a week for 24 weeks. The main efficacy end points were the safety of topical imiquimod and the overall clinical response in patients evaluated on the basis of modified AIDS Clinical Trials Group criteria at 36 weeks. The statistical analysis was based on the intent-to-treat data set.Seventeen patients

2008 Journal of the American Academy of Dermatology

1660. Topical immunomodulation under systemic immunosuppression: results of a multicentre, randomized, placebo-controlled safety and efficacy study of imiquimod 5% cream for the treatment of actinic keratoses in kidney, heart, and liver transplant patients. Full Text available with Trip Pro

Topical immunomodulation under systemic immunosuppression: results of a multicentre, randomized, placebo-controlled safety and efficacy study of imiquimod 5% cream for the treatment of actinic keratoses in kidney, heart, and liver transplant patients. In this study the safety and efficacy of imiquimod 5% cream for the treatments of actinic keratoses in kidney, heart and liver transplant recipients is evaluated.Growing populations of organ transplant recipients face increased risk of developing (...) actinic keratosis (AK) and skin cancer secondary to continuous systemic immunosuppressive therapy. Imiquimod 5% cream is an effective option for the treatment of AK, but the safety of topical immune stimulation in immunocompromised patients has not been widely evaluated.A total of 43 patients in six European transplant centres applied two sachets of topical imiquimod or vehicle cream three times per week to a 100 cm(2) field. Dosing continued for 16 weeks regardless of lesion clearance. Patients were

2007 The British journal of dermatology Controlled trial quality: uncertain

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