Formulation design and evaluation of the effect of hyaluronic acid hydrogel loaded with terbinafine lipid nanostructures in the treatment of patients with onychomycosis

Designing the formulation and determining the effect of hyaluronic acid hydrogel loaded with terbinafine lipid nanostructures in the treatment of patients with onychomycosis.

In this study, which is a double-blind clinical trial, 60 patients with the desired disease will enter the plan, who will be divided into 12 groups consist of 5 patients, according to gender and severity of the disease, and will receive hydrogel, placebo. All the patients should be the same in terms of the severity of the disease, the location of the lesion, and the age and gender range. After being referred by a doctor to a specialized mycology laboratory, the patient will be examined and if the microscopic observation and culture are positive, they will be included in the plan.

Tubi Clinic, Mazandaran, Medical Mycology Laboratory - After sampling and entering the plan, the patient will randomly receive the desired product and will be examined at intervals of 1, 2, and 4 weeks.

All patients with onychomycosis includes in the study and taking antifungal drugs and conscious withdrawing from the plan by patient or dermatologist will lead to exclude from the study.

Intervention group: patients suffering from onychomycosis will use the desired product in a form of varnish in a package of 60 g, 2 times a day for one months as supplement along with the application of the drug of choice (Terbinafin tablet). Control group: patients with onychomycosis, the desired placebo is used in the form of varnish in a form of varnish in a package of 60 g, 2 times a day for one months.

Improvement of fungal lesions in terms of clinical and mycological criteria

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.

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.

All information related to the study protocol and the informed consent form will be shared after the publication of the results.

After the publication of the desired article and results

All researchers in the relevant field

Citing sources

The article resulting from the plan

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