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Aldara Medical Research Studies

Up-to-date List of Aldara Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Aldara Medical Research Studies

Rank Status Study
1 Unknown  Imiquimod 3.75% Cream in Combination With Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses
Condition: Actinic Keratosis
Intervention: Drug: Cryotherapy alone to Left arm plus cryotherapy + imiquimod to Right arm
Outcome Measures: Clearance of Actinic Keratoses;   Local Skin Reactions (LSRs)
2 Not yet recruiting Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
Condition: Cervical Intraepithelial Neoplasia
Interventions: Drug: Imiquimod;   Procedure: Loop Electrosurgical Excision Procedure
Outcome Measures: Human Papillomavirus(HPV) Clearance;   Evidence of local or systemic side effects of Imiquimod cream;   Number of Participants with Serious and Non-Serious Adverse Events
3 Recruiting Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
Condition: Actinic Keratosis (AK)
Interventions: Drug: Ingenol Mebutate Gel, 0.015%;   Drug: Imiquimod Cream, 5%
Outcome Measures: Incidence of SCC;   Incidence of neoplasia
4 Recruiting Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
Condition: Actinic Keratoses
Interventions: Other: photodynamic therapy;   Drug: imiquimod 5% cream
Outcome Measures: Clinical complete response rate of actinic keratoses;   clinical complete response rate of actinic keratoses;   global reduction in the area of specific fluorescence;   global patient's satisfaction
5 Recruiting Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna
Condition: Lentigo Maligna
Intervention: Drug: Imiquimod
Outcome Measures: Elimination of possible subclinical lesions of LM that resides after surgical excision by determining the long-term recurrence rates.;   Incidence of subclinical residual lesions and local skin reactions.
6 Recruiting Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Condition: Vulvar Intraepithelial Neoplasia
Interventions: Drug: Imiquimod;   Procedure: Surgery
Outcome Measures: Complete clinical response;   Clinical response/ lesion size;   Histologic response;   Extent of surgery;   HPV status;   Clinical response/lesion size
7 Not yet recruiting Imiquimod, Fluorouracil, or Observation in Treating Patients With High-Grade Anal Squamous Skin Lesions Who Are HIV-Positive
Conditions: Anal Intraepithelial Neoplasia;   High-grade Squamous Intraepithelial Lesion;   HIV Infection
Interventions: Drug: imiquimod;   Drug: fluorouracil;   Other: questionnaire administration;   Other: laboratory biomarker analysis
Outcome Measures: Proportion of participants achieving complete response (Arm A and B);   Proportion of participants with spontaneous regression (Arm C);   Presence of intra-anal HSIL on cytology or histology;   Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0;   Proportion of participants achieving complete response or spontaneous regression;   Number of quadrants with HSIL found on biopsies;   Proportion of patients achieving complete or partial responses;   Persistence of HPV type specific infections
8 Unknown  Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Condition: Carcinoma, Basal Cell
Intervention: Drug: Imiquimod 5% cream
Outcome Measure: post-treatment biopsy
9 Recruiting Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia
Condition: Cervical Intraepithelial Neoplasia
Interventions: Drug: Topical Imiquimod;   Procedure: Conization
Outcome Measures: HPV clearance;   Rates of CIN remission/regression and/or CIN persistence/regression after treatment
10 Unknown  Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment
Condition: HPV
Intervention: Drug: Imiquimod
Outcome Measures: Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level;   Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy
11 Recruiting Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Cyclophosphamide;   Biological: DRibble vaccine;   Drug: Imiquimod;   Drug: GM-CSF;   Biological: HPV vaccine
Outcome Measures: Identify the regimen that produces the strongest antibody response;   Safety;   Progression free survival;   Immune response and progression-free survival correlation.
12 Unknown  Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Condition: Healthy
Interventions: Device: 1064 nm Nd:YAG laser;   Drug: Imiquimod, 5% cream
Outcome Measures: Bleaching of tattoo;   Bleaching of the tattoo
13 Recruiting Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma
Conditions: Diffuse Intrinsic Pontine Glioma;   Glioblastoma Multiforme;   Adult Glioblastoma
Interventions: Biological: Tumor Lysate Vaccine;   Drug: Imiquimod;   Radiation: Radiation therapy
Outcome Measures: Dose-limiting toxicity;   Drop-out rate;   Time to Tumor Progression
14 Recruiting Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
Condition: Lentigo Maligna Melanoma (Head or Neck)
Interventions: Drug: Imiquimod cream + surgery;   Drug: vehicle + surgery
Outcome Measures: The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm.;   The number of surgical re-excisions required to obtain complete remission.;   The number of recurrences, defined as the reappearance of pigmentation within 3 years of surgical excision.;   The number of histologically confirmed complete remissions under imiquimod.
15 Recruiting Comparison of Five Treatments in Patients With Plantar Warts
Condition: Plantar Warts
Interventions: Drug: Salicylate ointment;   Drug: Imiquimod;   Drug: 5-Fluoro-Uracil;   Drug: Cryotherapy
Outcome Measures: Complete clinical remission of the warts assessed by the dermatologist;   Time remission;   Number of warts in remission vs baseline;   Time to first relapse;   Percentage of relapse (phone call assessment);   Safety;   Evaluation of distress (visual analogic scale);   Compliance.
16 Recruiting Intradermal Influenza Vaccine in the Young
Condition: Influenza Viral Infections
Interventions: Drug: Imiquimod ointment;   Drug: Aqueous cream;   Biological: Intradermal influenza vaccine;   Biological: Intramuscular influenza vaccine
Outcome Measures: Seroconversion rate;   Seroprotection rate;   GMT fold increase;   GMT;   Adverse events
17 Recruiting Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
Conditions: Cervical Cancer;   Precancerous Condition
Interventions: Biological: TA-HPV;   Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine;   Drug: imiquimod
Outcome Measures: Safety (according to NCI CTCAE v3.0) and tolerability;   Change in histology (CIN3 or no CIN3) of biopsies between baseline and week 28;   Quantitative changes in cervical HPV viral load in exfoliated cell samples;   Changes in lesion size by serial digital colposcopy from week 0 to week 15;   Characterization of peripheral and local tissue response to vaccination on serially obtained peripheral blood specimens and on tissue samples from therapeutic resection;   Correlation of immune response with clinical response;   Correlation between measures of immune response and preclinical experimental data
18 Recruiting Study to Evaluate the Effects of Imiquimod and Tumor Lysate Vaccine Immunotherapy in Adults With High Risk or Recurrent/Post-Chemotherapy WHO Grade II Gliomas
Conditions: High Risk WHO Grade II Glioma;   Recurrent/Post-Chemotherapy WHO Grade II Glioma
Interventions: Biological: Tumor Lysate Vaccine;   Drug: Imiquimod
Outcome Measures: Safety;   Induction of BTIC Lysate-specific T-cell response
19 Not yet recruiting Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
Conditions: Anal Dysplasia;   Human Papilloma Virus;   HIV
Interventions: Drug: imiquimod;   Procedure: ablative
Outcome Measures: cytologic grade;   HPV
20 Recruiting Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
Condition: Malignant Glioma
Intervention: Biological: Dendritic Cell Vaccine in combination with Imiquimod cream
Outcome Measures: safety of an autologous tumor lysate- loaded dendritic cell (DC) vaccine with Imiquimod cream application;   progression free survival of patients after they receive tumor lysate-loaded DC vaccine with Imiquimod cream application.

These studies may lead to new treatments and are adding insight into Aldara etiology and treatment.

A major focus of Aldara research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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