Determination of the Effectiveness of Fluconazole Nano-Emulgel with its Oral Form in the Treatment of Dermatophytes
Design
Randomized, blinded, clinical trial with a parallel group design
Settings and conduct
A study was conducted in patients referring to Dermatology Clinic of Bouali Hospital and office in sari for 6 months. The physician and secretary were blinded.
Participants/Inclusion and exclusion criteria
Patients with cutaneous dermatophytosis
Intervention groups
Both groups of patients with cutaneous dermatophytosis receive an oral treatment group and the other receive topical treatment.
Main outcome variables
Irritation,Itching,Scalling,Erythema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190326043113N1
Registration date:2019-05-09, 1398/02/19
Registration timing:retrospective
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Farnaz Rajabali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2675 0655
Email address
rajabali.farnaz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-04-19, 1398/01/30
Scientific title
Comparative study of the efficacy of topical nano-emulsion fluconazole gel with its oral drug form in the treatment of dermatophytosis infections
Public title
Comparative study of nano-emulsion fluconazole gel with oral form in dermatophyte treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 10 years old
Patients with localized cutaneous dermatophytosis with a maximum of 3 to 4 patches
Not taking topical or oral antifungal medicines from 4 weeks ago
Not taking oral or topical steroids from 4 weeks ago
Exclusion criteria:
Pregnant and breastfeeding women
Diabetic patients taking sulfonylureas, tolbutamide and glyburide
Taking phenytoin and Coumarin Anticoagulants
onichomycosis
Dermatophytosis of head and beard
severe Cutaneous dermatophytosis
Age
From 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
we gave the doctor a specific number of two groups of medicine and a placebo, and the doctor treated the patient by random
Blinding (investigator's opinion)
Double blinded
Blinding description
As a researcher, I divided the medication and placebo into 2 groups A and B and gave the physician the right to distribute the drug among the patients without knowing which group contains topical treatment and which group contains oral treatment.
Placebo
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
Central headquarters of Mazandaran University of Medical Sciences and Health Services,beginning of Valiasr highway,
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
Ir.mazums.rec.1398.028
Health conditions studied
1
Description of health condition studied
Cutaneous dermatophyte
ICD-10 code
B35.4
ICD-10 code description
Tinea corporis
Primary outcomes
1
Description
Scratch rate
Timepoint
Zero, second, fourth and eighth week
Method of measurement
questionnaire
Secondary outcomes
1
Description
Flaking
Timepoint
The second, fourth and eighth weeks
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: receivers of the topical Fluconazole Nano-emolgel, formulated in the Pharmaceutical Laboratory of the Faculty of Pharmacy, and an oral placebo containing filled with avicel capsules.Patients receive medication for four weeks and follow up every two weeks. After discontinuation of the drug, after four weeks of recurrence of disease is examined. The topical product is given twice daily and oral capsule is given weekly.
Category
Treatment - Drugs
2
Description
Control group: receivers of the topical placebo, and an oral fluconazole 150 miligram capsules.Patients receive medication for four weeks and follow up every two weeks. After discontinuation of the drug, after four weeks of recurrence of disease is examined. The topical product is given twice daily and oral capsule is given weekly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Bouali Sari Hospital
Full name of responsible person
Farnaz Rajabali
Street address
Emam square, Pasdaran boulvard
City
Sari
Province
Mazandaran
Postal code
624304840015
Phone
+98 21 2675 0655
Email
rajabali.farnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid saeedi
Street address
17th kilometer of darya road
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3448 4800
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?