Determination of fluconazole nanoemulgel effectivness on Tinea versicolor in comparison with clotrimazole cream;
Design
Clinical trial (phase II) with control group, parallel, double blind and randomized on 60 patients. The patients will be randomized by choosing a sealed envelope containing intervention or control group code.
Settings and conduct
The patients in dermatology clinic, Boo-Ali hospital, Sari, will be divided to intervention or control group randomly, after clinical diagnosis. The diagnosis will be done based on clinical observation and positive smear test. The preparations will be packaged in similar tubes with definite code. Administrator, evaluator and patients are blind. The patients will receive medication 2 times daily for 8 weeks. The surface area of fungal lesion and clinical signs will evaluate at zero time, 2, 4 and 8 weeks after administration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Clinical observation of Tinea versicolor, above 5 years old and positive smear test.
Exclusion criteria: The cases suffered from liver disorders, renal failure, diabetes, malignant disease, pregnancy, breast feeding, use of anti fungal drugs in recent one month, sore or damage in infected area
Intervention groups
Intervention group: The eligible patients will receive Fluconazole nanoemulgel 0.5% (prepared in Sari faculty of pharmacy) twice daily for 8 weeks.
Control group: The eligible patients will receive Clotrimazole cream 1% (Pars Darou Co.) twice/day for 8 weeks.
Main outcome variables
Skin lesion area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120707010203N10
Registration date:2021-01-03, 1399/10/14
Registration timing:retrospective
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Majid Saeedi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3082
Email address
msaeedi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2017-09-22, 1396/06/31
Trial completion date
2017-09-22, 1396/06/31
Scientific title
Evaluation of Fluconazole-NLC nano emulgel (0.5%) effect on Tinea versicolor in comparison with clotrimazole cream
Public title
Treatment effect of topical fluconazole nanoparticles on Tinea versicolor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical feature of Tinea versicolor
Positive Smear test
Exclusion criteria:
Liver disease
Nephrotic disorders
Diabetes
Malignant disease
Pregnancy
Breast feeding
anti-fungal treatment in recent one months
Sore or damage in infected area
Age
From 5 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control using simple randomization and patients will divide to intervention or control group based on their code. Randomization list will be prepared by online tool (https://www.random.org/lists) and sealed envelope will be used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The fluconazole nano emulgel and clotrimazole cream will package in similar packaging. The preparations are similar in color and odor. The clinical researcher and patients will not be aware of the administered preparation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology building, Moallem sq., Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2014-09-21, 1393/06/30
Ethics committee reference number
IR.MAZUMS.REC.93.1109
Health conditions studied
1
Description of health condition studied
Tinea versicolor
ICD-10 code
B36.0
ICD-10 code description
Pityriasis versicolor
Primary outcomes
1
Description
Skin lesion area
Timepoint
At the beginning of study (time zero) and 2, 4 and 8 weeks after treatment
Method of measurement
Clinical evaluation and smear test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fluconazole nanoparticles (NLC) emulgel 0.5%, will be prepared in faculty of pharmacy and will be formulated as nano-emulgel 0.5%. The preparations will be packaged and receive code label, after physicochemical and microbial control. The patients will receive Fluconazole nano-emulgel twice daily for 8 months. They will not receive any other medication in this period of time.
Category
Treatment - Drugs
2
Description
Control group: Topical clotrimazole cream 1% (Pars Darou Co.) will be packaged in similar tubes to Fluconazole nano-emulgel and will be labeled by definite code. The patients will receive preparation twice/day for 8 months. They will not receive any other medication in this period of time.