Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel
Condition: Tinea
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Oxiconazole Nitrate Cream 1%; Oxiconazole nitrate SLNs loaded gel.
Intervention type(s): Drug; Drug
Intervention description(s): Tinox® group was treated with oxiconazole nitrate cream 1 % . Treatment was performed by rubbing the cream twice daily for two/ four weeks according to different types of tinea.; Oxiconazole nitrate SLNs loaded gel group was treated with oxiconazole nitrate SLNs loaded gel.Treatment was performed by rubbing the gel twice daily for two/ four weeks according to different types of tinea.
Other intervention name(s): Tinox® cream 1 %; Developed SLNs gel
Intervention MeSH terms: Oxiconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment