Clinical Assessment of Voriconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel

Sara Botros

Status and phase: Completed; Phase 2

Conditions: Tinea Versicolor

Treatments: Drug: voriconazole gel once daily; Drug: voriconazole gel twice daily; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04110860

VCZSaraSNEDDS

Details and patient eligibility

About

Clinical study for the developed voriconazole self nano emulsifying drug delivery system intermediate gel was conducted on 30 patients with tinea versicolor infection.

Full 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 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tinea Versicolor infection

Exclusion criteria

• concomitant treatment with other medications for the same condition being studied, TVC.
• pregnancy
• lactation
• immunocompromised patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

once daily application

Experimental group

Description:

the gel is applied to the affected areas once daily for one week followed by a follow-up visit to reassess the case. if complete cure is achieved, stop application. if not, repeat for one more week and then reassess.

Treatment:

Drug: voriconazole gel once daily

twice daily application

Experimental group

Description:

the gel is applied to the affected areas twice daily for one week followed by a follow-up visit to reassess the case. if complete cure is achieved, stop application. if not, repeat for one more week and then reassess.

Treatment:

Drug: voriconazole gel twice daily

placebo

Placebo Comparator group

Description:

the gel is applied to the affected areas twice daily for one week followed by a follow-up visit to reassess the case. if complete cure is achieved, stop application. if not, repeat for one more week and then reassess.

Treatment:

Drug: placebo