Clinical Assessment of Voriconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel
Clinical Assessment of Voriconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel
Clinical study for the developed voriconazole self nano emulsifying drug delivery system
 intermediate gel was conducted on 30 patients with tinea versicolor 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 30 patients
 (10 to 60 years old) with tinea versicolor attending the dermatology department outpatient
 clinic of Minia University Hospital. Local institutional review board approval was obtained
 for this study (ethical approval number is 24/18). Pregnant or lactating females and
 Immunocompromized patients. The patients were then divided into 3 groups, placebo group,
 group A and group B, consisting of 10 patients each. The placebo group received unmedicated
 formulation, Group A received the medicated formulation once daily and group B were treated
 twice daily. An informed consent has been obtained from all patients enrolled in the study
 for photography and treatment. History and general local examination were performed for all
 patients.The patients were clinically examined under normal light and using wood's lamp and
 cello-tape test was performed to confirm infection after determining the type of infection
 and in some cases scrapes were taken to detect infection in clinically indefinite cases and
 stained using potassium hydroxide 20% then examined for presence of fungal elements.
 Treatment was performed by applying the gel once or twice daily until full recovery was
 achieved with follow up once a week to reassess the condition. The clinical improvement of
 the patients, patient satisfaction and length of treatment were assessed. It was rated by
 both patient and physician as excellent, good, fair or 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 expectations, 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 some 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 treatment, on each follow up visit and after
 complete recovery. Clinical improvement was evaluated by physicians. The criteria for
 evaluations using a quartile grading scale were: 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 equal to or more than 75%). In
 addition, a patient satisfaction score was rated using the following scale, A. satisfied, B.
Inclusion Criteria:

 -  Tinea Versicolor infection

 Exclusion Criteria:

 -  concomitant treatment with other medications for the same condition being studied,
 TVC.

 -  pregnancy

 -  lactation

 -  immunocompromised patients