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IRCT20120707010203N11 IRCT 2021-01-11 Mazandaran University of Medical Sciences Evaluation of spironolactone nanoparticles coated with chitosan topical preparation effect on acne Evaluation of spironolactone nanostructured lipid carriers coated with chitosan and clindamycin solution co-treatment effect on severity of mild to moderate acne vulgaris 2020-10-22 anticipated 40 Complete https://irct.ir/trial/51477 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control using simple randomization and patients will divide to intervention or placebo group based on their code. Randomization list will be done by online tool (https://www.random.org/lists) and sealed envelope will used for concealment, Blinding description: All of patients will received clindamycin 2% solution in two groups. The patients will receive topical preparation of spironolactone nanoparticles 1% in case group, and control group will receive placebo in similar packaging. Topical preparation and placebo have certain code and clinical evaluator has no information about them. 2 acne vulgaris. Intervention 1: Intervention group: Topical preparation containing spironolactone nanoparticles (NLC) coated by chitosan (1%), will prepared as emulgel. The preparation will package and add code label , after physicochemical and microbial control. The patients will apply preparation twice in day for 8 months on skin lesions. They will receive clindamycin 2% solution as main treatment in this period of time too. Intervention 2: Control group: Topical placebo will prepared. The preparation will package and add code label , after physicochemical and microbial control. The patients will apply placebo twice in day for 8 months on skin lesions. They will receive clindamycin 2% solution as main treatment in this period of time too. No - There is not a plan to make this available Justification or reason for not sharing IPD is it is secret
public Majid Saeedi
18th. Km of khazar road, Faculty of Pharmacy
Sari Iran (Islamic Republic of) 4817844718 +98 11 3354 3084 msaeedi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Majid Saeedi
18th. Km of khazar road, Faculty of Pharmacy
Sari Iran (Islamic Republic of) 4817844718 +98 11 3354 3084 msaeedi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with mild to moderate acne, defined as a score of 1 to 30 on the global acne grading system (GAGS) scale. Patients which received no previous acne therapies participated in the study, or have not received any treatment before this study 13 years no limit Both Patients which received topical anti-acne therapy two months before or during the study or any systemic therapy with antibiotics, OCP, retinoid, and spironolactone before or during the study Patients were excluded if they had other disease; Pregnant, or planning to become pregnant women Lactating L70.0 Acne vulgaris Treatment - Drugs Placebo Intervention group: Topical preparation containing spironolactone nanoparticles (NLC) coated by chitosan (1%), will prepared as emulgel. The preparation will package and add code label , after physicochemical and microbial control. The patients will apply preparation twice in day for 8 months on skin lesions. They will receive clindamycin 2% solution as main treatment in this period of time too. Control group: Topical placebo will prepared. The preparation will package and add code label , after physicochemical and microbial control. The patients will apply placebo twice in day for 8 months on skin lesions. They will receive clindamycin 2% solution as main treatment in this period of time too. No. of lesions. Timepoint: At the beginning of study (time zero) and 2, 4 and 8 weeks after treatment. Method of measurement: clinical evaluation. Lesion kind (inflammatory or non-inflammatory). Timepoint: At the beginning of study (time zero) and 2, 4 and 8 weeks after treatment. Method of measurement: Clinical evaluation. Mazandaran University of Medical Sciences Approved 2020-10-10 Ethics committee of Mazandaran University of Medical Sciences Deputy of Research and Technology building, Moallem sq., Sari, Iran Sari Mazandaran Iran (Islamic Republic of)