Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel
Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel
Clinical study for the developed oxiconazole nitrate solid lipid nanoparticles (SLNs) gel
 system compared to the corresponding marketed product was conducted on 28 patients with
 different types of tinea fungal infection.
The clinical work has been carried out in accordance with The Code of Ethics of the World
 Medical Association for experiments involving humans. The study was conducted on 28 patients
 (12 to 50 years old) with tinea of different types attending the dermatology department
 outpatient clinic of Minia University Hospital. Local institutional review board approval was
 obtained for this study (ethical approval number is 23/12). Pregnant females and patients
 with Immunocompromising disease,open wounds and psychological disorders were excluded.
 Patients were subjected to skin irritation test by applying gel on an area of 2 square inch
 to the back of hand. Then, examination for the presence of lesion or irritation was
 conducted. The patients divided into two groups of 14 patients each. Tinox® group was male
 patients from 12 to 43 years old. The included cases were 5 tinea pedis, 9 tinea versicolor.
 Oxiconazole nitrate SLNs loaded gel group was 13 males and one female from17 to 50 years old.
 The included cases were 3 tinea pedis, 8 tinea versicolor, 3 tinea circinate. An informed
 consent has been obtained from all patients enrolled in the study for photography and
 treatment. History, general local examination and laboratory investigation for all patients
 were conducted.The patients were clinically examined after determining the type of infection.
 Tinox® group was treated with Tinox® cream 1 % while oxiconazole nitrate SLNs loaded gel
 group was treated with the oxiconazole nitrate SLNs-loaded gel. Treatment was performed by
 rubbing the cream or gel twice daily for two/ four weeks according to different types of
 tinea. Patients were advised to avoid sun exposure between 10 am and 4 pm and avoid removal
 of the applied dose during the period of follow up, the clinical improvement of the patients
 and length of treatment was assessed according to quartile grading scale patient
 satisfaction. It was rated by the patient and the physician as excellent, good, fair and poor
 according to the following criteria. Excellent: both the patient and the physician agreed
 that the result was satisfactory. Good: the result although acceptable was not quite up to
 expectation of the patient, but the physicians were pleased with the outcome. Fair: the
 improvement was evaluated by both the patient and the physician to be less than expected but
 still with same improvement. Poor: unsatisfactory results to the patient and /or the
 physician. All adverse effects were checked during study.High resolution digital photographs
 were taken for lesions of all patients using identical camera folder setting before starting
 and one-month post treatment. Clinical improvement was evaluated by physicians through
 comparing photographs. The criteria for evaluations using a quartile grading scale was: 0=no
 improvement. 1=mild (percent improvement, less than 25%), 2=moderate (percent improvement
 25-49%), 3=good (percent improvement 50-74%), 4=excellent (percent improvement more than
 75%). In addition, a patient satisfaction score was rated using the following scale, A. not
 satisfied, B. somewhat satisfied, C. highly satisfied.

 Skin scrapes were taken from each group before and after treatment. All skin scrapes were
 routinely processed by potassium hydroxide 20% to be examined for presence of fungal
 elements. A built-in camera and a light microscope were used to photograph and examine the
 sectioned skin areas.

 IBM SPSS® ( International business machine statistical Package for the Social Sciences
 (version 22, USA) was utilised for data analysis. The acceptability of the tested
 formulations was assessed using the chi-square test, P ≤ 0.05 was considered statistically
 significant. All the results were presented as the mean ± standard deviation (SD).
Inclusion Criteria:

 -  patients with different types of tine infection

 Exclusion Criteria:

 -  Pregnant females and patients with Immunocompromising disease, open wounds and
 psychological disorders were excluded.