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IRCT20181217042030N1 IRCT 2019-05-01 Gorgan University of Medical Sciences The therapeutic effect of nano-Curcumin on skin lesion of psoriasis Evaluation of anti-inflammatory effects of curcumin which is encapsulated by niosomal nano-carrier in lesional skin of psoriatic patient: A pilot and clinical trial study 2019-05-22 anticipated 10 Complete https://irct.ir/trial/36038 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: This is a full-matched clinical trial study with with-in patient (internal) comparison group and the study unit are Lesions instead of patients, Randomization description: Since the patient lesions will be the study units and eligible patients have two similar lesions, one lesions will receives one of the interventions and the other comparison. By using a Randomizer software, on set of random numbers (i.e.1 to 10) will be generated. patient with odd number will receive intervention treatment on right lesion and comparison treatment on left lesion and patients with even number will receive intervention treatment on left lesion and comparison treatment on right lesion, Blinding description: In this study blinding would be performed for patients and also for persons which do sampling and experiment. Randomization would be done by one colleague. Drug and placebo ointments would be applied for patients as a left or right drug, after taken an informed consent. Patients and the sampler (specialist) are not aware which treatments are received because drug and placebo would have same features and sampling will be done in the same way. Finally, researchers will receive samples only with the codes. 2 Psoriasis. Intervention 1: Intervention group: patients were instructed to apply the niosome-curcumin ointment of 5 micromolar curcumin once a day for 4 weeks on their eligible skin lesions. Intervention 2: Comparison group: patients were instructed to apply the placebo ointment (curcumin without niosome) once a day for 4 weeks on eligible skin lesions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This is a Pilot study.
public Hanieh Kolahdooz
Immunology Department, School of Medicine, Shast-Kola Road, Golestan University of Medical Sciences
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3245 1644 hanieh.klz@goums.ac.ir Golestan University of Medical Sciences scientific Ali Memarian
Golestan university of medical sciences, Shast-Kola road, Gorgan
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3245 1644 alimemarian@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Parallel lesional skin of Psoriatic patient lesions from mild or severe form of disease Age >+18 Signing the informed consent form 18 years no limit Both Pregnant and lactation Suffering from autoimmune or other inflammation diseases Suffering from Cirrhosis and Hepatic disease Suffering from Metabolic syndrome Suffering from severe Renal disease Allergic reaction to Curcumin L40.0 Psoriasis vulgaris Treatment - Drugs Placebo Intervention group: patients were instructed to apply the niosome-curcumin ointment of 5 micromolar curcumin once a day for 4 weeks on their eligible skin lesions Comparison group: patients were instructed to apply the placebo ointment (curcumin without niosome) once a day for 4 weeks on eligible skin lesions IL23 gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). IL17 gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). TNFα gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). IL22 gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). S100A7 gene expresion. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). S100A12 gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). βefensin2 gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). Ki67 gene expression. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Real time PCR and evaluating of gene expression exchange to control gene (18sRNA). Accumulation of immune cells in lesional skin tissue. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: H&E staining and optical microscopy. Local disease severity. Timepoint: 4 weeks after local treatment with encapsulated curcumin by noisome. Method of measurement: Observation by physician. Side effects (systemic and local). Timepoint: A phone number were given to patients for any emmergency call during treatment. Patient could report any side effects 24/7 as well as during follow-ups, all the way through the treatment and after completion. Method of measurement: Medical examination by the consultant dermatology. Gorgan University of Medical Sciences Approved 2019-03-04 Ethics Committee of Golestan University of Medical Sciences Shast-Kola road Gorgan Golestan Iran (Islamic Republic of)