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Imiquimod

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1661. Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses

Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses - 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. Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses 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: NCT00110682 Recruitment Status : Completed First Posted : May 13, 2005 Last Update Posted : April 24, 2008 Sponsor: Derm

2005 Clinical Trials

1662. Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin

Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin - 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 and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin 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

2007 Clinical Trials

1663. Imiquimod 5% cream as adjunctive therapy for primary, solitary, nodular nasal basal cell carcinomas before Mohs micrographic surgery: a randomized, double blind, vehicle-controlled study. Full Text available with Trip Pro

Imiquimod 5% cream as adjunctive therapy for primary, solitary, nodular nasal basal cell carcinomas before Mohs micrographic surgery: a randomized, double blind, vehicle-controlled study. Imiquimod 5% cream is currently approved for treatment of nonfacial, superficial basal cell carcinomas (BCCs). Topical imiquimod might be a reasonable candidate for adjunctive therapy of nodular, nasal BCCs before Mohs surgery.To observe the effectiveness of imiquimod 5% cream in reducing the number of Mohs (...) stages, defect size, cost of Mohs surgery, and reconstruction.Patients applied the study medication nightly for 6 weeks with occlusion followed by a 4-week rest period before Mohs surgery was performed.No differences were demonstrated in the number of Mohs stages, defect sizes, or costs between the two groups, possibly because of our small sample size. Only five of 12 patients (42%) in the treatment group were found histologically clear of tumor (complete responders).Imiquimod 5% cream

2009 Dermatologic Surgery Controlled trial quality: uncertain

1664. Placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 6 months for the treatment of actinic keratoses. (Abstract)

Placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 6 months for the treatment of actinic keratoses. Imiquimod 5% cream applied twice weekly for 16 weeks is effective for treating actinic keratoses but may be limited by local side effects.We sought to explore the efficacy and safety of a once weekly for 24 weeks dosing regimen using a left versus right side of head design.Twenty patients were enrolled; 15 completed and 5 discontinued (...) for reasons unrelated to adverse events. At the posttreatment visit (week 28), 7 (46.7%) of 15 patients had marked improvement or better on the imiquimod side versus one (6.7%) of 15 on the placebo side. The average investigator assessment scale score change was +2.20 for imiquimod compared with -0.27 for placebo (P = .0002, Wilcoxon signed rank test). Skin reactions were minimal or nonexistent in most patients.Limitations of the study include a small sample size and a lack of objective measure of local

2009 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

1665. Treatment of actinic keratoses with sequential use of photodynamic therapy; and imiquimod 5% cream. (Abstract)

Treatment of actinic keratoses with sequential use of photodynamic therapy; and imiquimod 5% cream. Field-directed therapies for actinic keratosis include photodynamic therapy and imiquimod.The author designed a randomized, vehicle-controlled, split-face study to explore the safety and efficacy of photodynamic therapy followed by imiquimod.The entire face of adults with > or =10 facial actinic keratoses were treated with photodynamic therapy with aminolevulinic acid 20% at baseline and at month (...) 1. At month 2, imiquimod 5% cream was applied to one-half of the face and vehicle to the other half, 2-times-per-week for 16 weeks. Lesion counts were performed at baseline and months 1, 2, 3, 4, 6, and 12; and local skin reactions assessments at months 2, 3, 4, and 6.Of 25 participants enrolled, 24 completed the study. Baseline median lesions were 23.5 and 21.5 for the imiquimod- and vehicle-treated sides, respectively. At month 12, median lesion reductions was 89.9% versus 74.5% (P=.0023

2009 Journal of drugs in dermatology : JDD Controlled trial quality: uncertain

1666. Treatment of keloid scars post-shave excision with imiquimod 5% cream: A prospective, double-blind, placebo-controlled pilot study. (Abstract)

Treatment of keloid scars post-shave excision with imiquimod 5% cream: A prospective, double-blind, placebo-controlled pilot study. No effective treatment exists for permanent keloid removal. When applied to excised-sites, imiquimod 5% cream reduces keloid recurrence. Case series suggest the tolerability and efficacy of imiquimod 5% application to sites of shaved keloids; however, this has not been verified in placebo-controlled studies.To determine the tolerability and compare the efficacy (...) of imiquimod 5% and vehicle cream in lowering keloid recurrence after shaving.Twenty randomized, shaved keloids were administered imiquimod 5% or vehicle cream nightly for two weeks, and then given three times a week under occlusion for one month. Pain, tenderness, pruritus and keloid recurrence were evaluated at baseline, week 2, week 6 and 6 months.Tenderness and pain were significantly (p = 0. 02 and p = 0. 02, respectively) higher at week 2 in the imiquimod group than for those treated with vehicle

2009 Journal of drugs in dermatology : JDD Controlled trial quality: uncertain

1667. Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. (Abstract)

Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod 5% cream in conjunction with the 1,064-nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser treatment alone, which is the standard for cosmetic removal of tattoos. Previous studies have linked partial tattoo removal to imiquimod application in a guinea pig model.This was a small-sized, double-blinded (...) the second visit, tattoos were randomized and chosen to receive either the laser-imiquimod treatment course or laser-vehicle cream treatment. The patients returned 1 month after the completion of cream application (week #10) and 2 months after the completion of treatment with cream (week #14) for final evaluation and photographing.Three patients were enrolled in this study. All of them are Fitzpatrick skin type IV. All of the patients were compliant with the drug application and have good tolerability

2009 Lasers in medical science Controlled trial quality: uncertain

1668. Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial. (Abstract)

Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial. Clinical studies in cutaneous conditions other than actinic keratosis (AK) have revealed that the safety and efficacy profile of imiquimod is influenced by dosing frequency.To evaluate dosing frequency response of imiquimod 5% for treatment of AK.This was a phase II, multicentre, randomized, double-blind (...) , placebo-controlled study. Adults with > or = 10 but < or = 50 clinical AKs, one of which was histologically confirmed, were randomized (4:1) to 2-6 packets of imiquimod or placebo cream applied to the dorsum of the forearms and hands once daily 2, 3, 5 or 7 times per week for 8 weeks. The primary endpoint was complete clearance of AKs in the treatment area at 8 weeks post-treatment.One hundred and forty-nine (94 men and 54 women) white subjects, with a mean +/- SD age of 71 +/- 10.2 years, were

2009 The British journal of dermatology Controlled trial quality: predicted high

1669. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. Full Text available with Trip Pro

First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated.A randomized (...) double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re

2009 PLoS neglected tropical diseases Controlled trial quality: predicted high

1670. Intraindividual, right-left comparison of topical 5-aminolevulinic acid photodynamic therapy vs. 5% imiquimod cream for actinic keratoses on the upper extremities. (Abstract)

Intraindividual, right-left comparison of topical 5-aminolevulinic acid photodynamic therapy vs. 5% imiquimod cream for actinic keratoses on the upper extremities. Actinic keratoses (AKs) are considered as in situ squamous cell carcinoma. Early and effective treatment is important. Objective To compare the efficacy, cosmetic outcome and patient preference of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) with that of 5% imiquimod (IMIQ) cream in patients with AKs on the dorsa of hands (...) and forearms.Subjects received two ALA-PDT treatment sessions and one or two courses of imiquimod (three times per week for 4 weeks each). Treatments were randomly allocated to alternate upper extremities. Assessments included lesion response one and six months after treatment, cosmetic outcome evaluated by the investigators and patients' preference 6 months after treatment. Efficacy end point included the individual AK lesion clearance rate.Thirty patients with 256 lesions were included in the study. At the first

2009 Journal of the European Academy of Dermatology and Venereology : JEADV Controlled trial quality: uncertain

1671. Long-term clinical outcomes following treatment of actinic keratosis with imiquimod 5% cream. (Abstract)

Long-term clinical outcomes following treatment of actinic keratosis with imiquimod 5% cream. The results from four phase III, randomized, vehicle-controlled studies showed that imiquimod 5% cream (imiquimod) was safe and effective in the treatment of actinic keratosis (AK). Patients applied imiquimod or vehicle cream to AK lesions on the face or balding scalp, dosing three times per week or two times per week for 16 weeks.To obtain long-term safety follow-up data and estimate AK recurrence (...) in patients who completely cleared their AK lesions in the treatment area at the 8-week post-treatment visit in the phase III studies.One hundred forty-six patients from 30 study centers in the United States were evaluated for clinical evidence of AK, and safety data were collected.After a median follow-up period of 16 months, 24.7% (19 of 77) of the patients administered imiquimod three times per week and 42.6% (23 of 54) of the patients administered imiquimod two times per week had a recurrence of AK

2005 Dermatologic Surgery Controlled trial quality: uncertain

1672. Double-blind, randomized, placebo-controlled, prospective study evaluating the tolerability and effectiveness of imiquimod applied to postsurgical excisions on scar cosmesis. (Abstract)

Double-blind, randomized, placebo-controlled, prospective study evaluating the tolerability and effectiveness of imiquimod applied to postsurgical excisions on scar cosmesis. It has been reported that topical application of imiquimod 5% cream induces interferon-alpha, an antifibrotic cytokine.To determine the tolerability and effectiveness on the cosmetic outcome of the application of imiquimod to postsurgical excision sites.A prospective, double-blinded, randomized, vehicle-controlled trial (...) was conducted among 20 patients with two skin lesions clinically diagnosed as melanocytic nevi. Imiquimod 5% cream was applied to one of the sutured surgical wounds starting the night of the excision nightly for a period of 4 weeks. The second sutured excision site was treated with vehicle cream. Scar cosmesis, erythema, pigmentary alterations, induration, tenderness, and pain were assessed using a visual analogue scale 2, 4, and 8 weeks after surgery.Eighteen subjects completed the study, with a total

2005 Dermatologic Surgery Controlled trial quality: uncertain

1673. Imiquimod-induced regression of actinic keratosis is associated with infiltration by T lymphocytes and dendritic cells: a randomized controlled trial. (Abstract)

Imiquimod-induced regression of actinic keratosis is associated with infiltration by T lymphocytes and dendritic cells: a randomized controlled trial. Imiquimod 5% cream is a topically applied immune response modifier that has been shown to give effective treatment of actinic keratosis (AK). The therapeutic effects of imiquimod are likely to involve the provocation of a cutaneous immune response against abnormal cells, an assumption based on a strong correlation between complete clearance rates (...) and the severity of the local skin reactions (erythema, oedema, erosion/ulceration, weeping/exudation and scabbing/crusting); however, no clinical studies have conclusively proved this mechanism.To determine the nature of cellular infiltrates induced by the application of imiquimod to AK lesions and to study cells involved in the cutaneous immune response.Eighteen patients participated in this phase I, randomized, double-blind, parallel group, vehicle-controlled study. Enrolled patients were randomized in a 2

2006 The British journal of dermatology Controlled trial quality: uncertain

1674. Pilot study of imiquimod 5% cream as adjunctive therapy to curettage and electrodesiccation for nodular basal cell carcinoma. (Abstract)

Pilot study of imiquimod 5% cream as adjunctive therapy to curettage and electrodesiccation for nodular basal cell carcinoma. Curettage and electrodesiccation (C&D) is a widely used method to treat nodular basal cell carcinoma (BCC). However, residual tumor is present immediately after the procedure in approximately 20 to 40% of cases. Imiquimod, a topical immune response modifier that targets Toll-like receptor 7, is currently approved for superficial BCC.In a double-blind, vehicle-controlled (...) study, the administration of imiquimod after C&D was investigated to determine if the combination regimen would reduce the frequency of residual tumor compared with C&D alone in patients with nodular BCC.Twenty patients received three cycles of C&D followed by imiquimod 5% or vehicle cream once daily for 1 month as adjunctive therapy. The primary end point was the frequency of residual tumor. The secondary end points included the time to heal and cosmetic appearance.Twenty patients were randomized

2006 Dermatologic Surgery Controlled trial quality: uncertain

1675. Safety and efficacy of 5% imiquimod cream for the treatment of skin dysplasia in high-risk renal transplant recipients: randomized, double-blind, placebo-controlled trial. Full Text available with Trip Pro

Safety and efficacy of 5% imiquimod cream for the treatment of skin dysplasia in high-risk renal transplant recipients: randomized, double-blind, placebo-controlled trial. To evaluate the safety and efficacy of 5% imiquimod cream for cutaneous dysplasia in high-risk renal transplant recipients.A randomized, blinded, placebo-controlled study comparing treated with control skin.A specialist organ transplant dermatology clinic.Twenty-one high-risk patients with skin cancer with comparable areas (...) creatinine levels, and tumors developing in the study sites.Fourteen patients receiving imiquimod and 6 receiving placebo completed the study. Seven patients using imiquimod (1 taking placebo) had reduced skin atypia, 7 using imiquimod (none taking placebo) had reduced viral warts, and 5 using imiquimod (1 taking placebo) showed less dysplasia histologically. In 1 year, fewer squamous skin tumors arose in imiquimod-treated skin than in control areas. Renal function was not adversely affected.Topical 5

2005 Archives of Dermatology Controlled trial quality: predicted high

1676. Evaluation of imiquimod 5% cream to modify the natural history of herpes labialis: a pilot study. Full Text available with Trip Pro

Evaluation of imiquimod 5% cream to modify the natural history of herpes labialis: a pilot study. Imiquimod is currently approved for the treatment of genital warts and has been shown to decrease recurrences of genital herpes in the guinea pig model of genital herpes. Therefore, we evaluated the safety and potential of topical imiquimod to decrease the rate of recurrence in humans with a history of recurrent herpes labialis.Forty-seven subjects with recurrent herpes labialis applied imiquimod 5 (...) % (n=30) or vehicle cream (n=17) to recurrent lesion(s) on days 1, 3, and 5 of the study (day 1 of observation occurred within 48 h after recurrence of lesion). Subjects were seen at the study centers between each dose and 3 days after application of the final dose or until resolution of the lesion.After application to recurrent lesions, local erythema, edema, scabbing and/or flaking, pain, burning, and maximal lesion size were significantly greater in the imiquimod group than in the vehicle group

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

1677. 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

1678. 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

1679. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. Full Text available with Trip Pro

Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. The objective of this study was to identify the molecular processes responsible for the anti-lesional activity of imiquimod in subjects with actinic keratosis using global gene expression profiling.A double-blind, placebo-controlled, randomized study was conducted to evaluate gene expression changes in actinic keratosis treated with imiquimod 5% cream. Male subjects (N = 17) with > or = 5 actinic (...) keratosis on the scalp applied placebo cream or imiquimod 3 times a week on nonconsecutive days for 4 weeks. To elucidate the molecular processes involved in actinic keratosis lesion regression by imiquimod, gene expression analysis using oligonucleotide arrays and real time reverse transcriptase polymerase chain reaction were performed on shave biopsies of lesions taken before and after treatment.Imiquimod modulated the expression of a large number of genes important in both the innate and adaptive

2007 Journal of translational medicine Controlled trial quality: uncertain

1680. Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts. (Abstract)

Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts. Conventional ablative treatments for external anogenital warts are affected by high recurrence rates. This study compared sustained clearance after ablation vs. treatment with imiquimod 5% cream vs. the combination of both methods. This was a 3-arm, open-label, randomized clinical study comparing ablation alone (Group A), imiquimod 5% cream (...) monotherapy (Group B), or combined ablation followed by topical imiquimod (Group C). Subjects whose anogenital warts were completely cleared entered a 6-month follow-up to evaluate sustained clearance. After 3 months follow-up, 83.9% (73/87), 93.8% (90/96) and 91.7% (66/72) of subjects in Groups A, B, C, respectively, remained free of recurrent anogenital warts. After 6-months follow-up, 73.6% (64/87), 93.7% (89/95) and 91.5% (65/71) of subjects presented free of recurrence (Group A vs. B & C p-values

2007 European journal of dermatology : EJD Controlled trial quality: uncertain

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