Clinical Assessment of Voriconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel
Clinical Evaluation of a Formulated Nanoemulsion for Topical Application
1 other identifier
interventional
30
1 country
1
Brief Summary
Clinical study for the developed voriconazole self nano emulsifying drug delivery system intermediate gel was conducted on 30 patients with tinea versicolor infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
September 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedOctober 1, 2019
September 1, 2019
4 months
September 28, 2019
September 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
complete cure
1-4 weeks
Study Arms (3)
once daily application
EXPERIMENTALthe 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.
twice daily application
EXPERIMENTALthe 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.
placebo
PLACEBO COMPARATORthe 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.
Interventions
voriconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas once daily
voriconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas twice daily
the same procedure as before is used to prepare the nanoemulsion intermediate gel but the active ingredient, voriconazole, is not added then applied twice daily in the same manner
Eligibility Criteria
You may qualify if:
- Tinea Versicolor infection
You may not qualify if:
- concomitant treatment with other medications for the same condition being studied, TVC.
- pregnancy
- lactation
- immunocompromised patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Botroslead
Study Sites (1)
Minia University hospital
Minya, Minya Governorate, 61519, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara R Botros, bachelor of clinical pharmacy
Minia University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- demonstrator
Study Record Dates
First Submitted
September 28, 2019
First Posted
October 1, 2019
Study Start
February 15, 2018
Primary Completion
June 20, 2018
Study Completion
June 30, 2018
Last Updated
October 1, 2019
Record last verified: 2019-09