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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110834
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Botros, Minia University

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

Condition or disease Intervention/treatment Phase
Tinea Versicolor Drug: itraconazole gel once daily Drug: itraconazole gel twice daily Drug: placebo Phase 2

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 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.

somewhat satisfied, C. not satisfied. 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Formulated Nanoemulsion for Topical Application
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arm Intervention/treatment
Experimental: once daily application
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.
Drug: itraconazole gel once daily
itraconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas once daily

Experimental: twice daily application
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.
Drug: itraconazole gel twice daily
itraconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas twice daily

Placebo Comparator: placebo
the gel is applied to the affected areas twice daily for one week followed by a follow-up visit to assure that the results obtained from other arms are only due to the effects of the active ingredient in the prepared gel.
Drug: placebo
the same procedure as before is used to prepare the nanoemulsion intermediate gel but the active ingredient, itraconazole, is not added then applied twice daily in the same manner




Primary Outcome Measures :
  1. complete cure [ Time Frame: 1-4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tinea Versicolor infection

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110834


Locations
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Egypt
Minia University hospital
Minya, Minia, Egypt, 61519
Sponsors and Collaborators
Sara Botros
Investigators
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Principal Investigator: Sara R Botros, bachelor of clinical pharmacy Minia University
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Responsible Party: Sara Botros, demonstrator, Minia University
ClinicalTrials.gov Identifier: NCT04110834    
Other Study ID Numbers: ITZSaraSNEDDS
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinea Versicolor
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors