]>
IRCT20210611051539N4 IRCT 2023-11-19 Mazandaran University of Medical Sciences Investigating the effect of hyaluronic acid hydrogel loaded with terbinafine lipid nanostructures in the treatment of patients with onychomycosis Formulation design and evaluation of the effect of hyaluronic acid hydrogel loaded with terbinafine lipid nanostructures in the treatment of patients with onychomycosis 2023-11-06 anticipated 60 Complete https://irct.ir/trial/72700 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, terbinafine hydrogel and placebo will be prepared in identical packages and in order to observe random allocation, www.randomizer.org website is used by applying the codes received from the site, the drug and the placebo are separated and then placed inside a similar envelope and will give to the patients completely random. Therefore, the patients will not be informed about the nature of the drug and the type of group it belongs to. Also, both medicine and placebo are mixed together in a closed package and the doctor or expert randomly gives the medicine to the patient, Blinding description: The patients participating in the study, as well as the researcher, who includes the PHD student who is responsible for completing his thesis, as well as the collaborating doctors who perform the intervention, are blinded in the study. The drug and placebo are all three with the same packaging in Special envelopes are placed and the associate doctors and students who perform the intervention are not aware of its contents. Only the drug code and the patient code will be written in the questionnaire. But the project manager as an analyst is aware of the codes and their allocation to control and intervention groups. On the other hand, the participants are not aware of the content of the envelope, but they will be informed that their complementary medicine may be a placebo. 3 Onychomycosis. Intervention 1: Intervention group: For patients with onychomycosis, terbinafine hydrogel and placebo in Mazandaran University of Medical Sciences in 100 gram tubes, 2 times a day for 1 months. This intervention is used as a medical supplement along with the drug of choice which is determined by a dermatologist. Intervention 2: Control group: Placebo is used for patients with onychomycosis in Mazandaran University of Medical Sciences in 60 gram tubes, 2 times a day for 1 months. This intervention is used as a medical supplement along with the drug of choice which is determined by a dermatologist. 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 A decision will be made after the plan is completed.
public Dr. Maryam Moazeni
Shayan 3 Bldg, Ghaem 12 St., Ghaem St., Taleghani Blvd., Sari
Sari Iran (Islamic Republic of) 4817845423 +98 11 3325 7911 moazeni.maryam@gmail.com Mazandaran University of Medical Sciences scientific Dr. Maryam Moazeni
Shayan 3 Bldg, Ghaem 12 St., Ghaem St., Taleghani Blvd., Sari
Sari Iran (Islamic Republic of) 4817845423 +98 11 3325 7911 moazeni.maryam@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) All patients with onychomycosis no limit no limit Both Taking antifungal drugs Conscious withdrawal of the patient Leaving the plan with the order of a dermatologist B35.1 Tinea unguium Treatment - Drugs Placebo Intervention group: For patients with onychomycosis, terbinafine hydrogel and placebo in Mazandaran University of Medical Sciences in 100 gram tubes, 2 times a day for 1 months. This intervention is used as a medical supplement along with the drug of choice which is determined by a dermatologist. Control group: Placebo is used for patients with onychomycosis in Mazandaran University of Medical Sciences in 60 gram tubes, 2 times a day for 1 months. This intervention is used as a medical supplement along with the drug of choice which is determined by a dermatologist. Improvment of fungal lesions in term of clinical and mycological criteria. Timepoint: before the start of the intervention and 1, 2 and 4 weeks after the start of the treatment. Method of measurement: Examination of clinical symptoms in terms of lesion healing by a doctor and examination in terms of direct smear and fungal culture in the interval of 1, 2 and 4 weeks. Mazandaran University of Medical Sciences Approved 2023-01-24 Mazandaran University of Medical Sciences ethics committee Shayan 3 Bldg., Ghaem 12 St., Ghaem St., Moalem Sq. Sari Mazandaran Iran (Islamic Republic of)