Evaluation of the Effect of Topical Liposomal Amphotericin B Compared to Clotrimazole Cream in the Treatment of Patients with Tinea Versicolor- single -Blind Clinical Trial.
Comparison of the efficacy of Liposomal Amphotericin B 0.4% gel and Clotrimazole 1% cream in the treatment of Tinea versicolor
Design
Phase 3, Parallel group, clinical trial, with consecutive sampling, including 44 patients, single blinded, computerized randomised with permuted blocks.
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical sciences. Group 1 Will apply Liposomal Amphotericin B 0.4% gel twice daily on the leasions. Group 2 will apply Clotrimazole 1% cream twice daily on the leasions. The patients are assessed at the beginning of treatment, then two weeks after treatment by Direct KOH 10% smear. The assessor is blinded to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: between 15 to 50 years of age patients with Tinea versicolor؛ less than of 10% of body surface area. Exclusion criteria: pregnancy or lactation, history of hypersensitivity to topical Clotrimazole or Liposomal Amphotericin B, history of consumption of topical or systemic antifungal medication in the resent 1 month before enrolling study.
Intervention groups
Intervention group: Liposomal Amphotericin B 0.4% gel ( Sina ampholish; Exir nano sina, Tehran, Iran) is applied twice daily. Control group: Clotrimazole 1% cream ( Najo, Tehran, Iran ) is applied twice daily.
Main outcome variables
Malassezia species positiveity, scale and hyperpigmentation on lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220221054082N1
Registration date:2022-03-17, 1400/12/26
Registration timing:registered_while_recruiting
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
Malek Khedri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9049
Email address
m.khedri1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-07, 1400/12/16
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical Liposomal Amphotericin B Compared to Clotrimazole Cream in the Treatment of Patients with Tinea Versicolor- single -Blind Clinical Trial.
Public title
Comparison of the efficacy of Liposomal Amphotericin B gel and Clotrimazole cream in treatment of Tinea versicolor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of Tinea versicolor and confirmation of diagnosis by Direct smaer
Patients of between 15 to 50 years old
Less than 10% of body surface area
Exclusion criteria:
Pregnancy
Lactation
History of hypersensitivity to topical Clotrimazole or Liposomal Amphotericin B
History of consumption of topical or systemic antifungal medication in the resent 1 month before enrolling study
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 44 participants in the software is performed by permuted blocks includes eleven four blocks. The output of the software is a table that shows the number of each participant is allocated in the intervention or control group. This software is taken from the site Randomization.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because the drugs have different textures ( gel vs. cream ) the study is only investigator blinded. The assessment will be done by another clinician who is blinded to treatment. The patients will be instructed not to discuss the texture or labing of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical sciences
Street address
Shiraz, university of Medical sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-02-03, 1399/11/15
Ethics committee reference number
IR.SUMS.MED.REC.1399.543
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
Malassezia species positiveity
Timepoint
0, 14th days
Method of measurement
Direct KOH 10% smear
2
Description
Scale and hyperpigmentation grade
Timepoint
0, 14th days
Method of measurement
Physician global assess
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Liposomal Amphotericin B 0.4% gel (Sina Ampholish, Exir, nano sina ) is applied twice daily on the leasions, for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: Clotrimazole 1% cream ( Najo, Tehran, Iran ) is applied twice daily on the leasions, for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Mehdi Ghahartars
Street address
Dermatology clinic, Shahid Faghihi hospital, Zand St., Shiraz City
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mghahar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzade
Street address
Research Council, Shiraz University of Medical sciences, Zand St., Shiraz City
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical sciences
Grant code / Reference number
22355
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ghahartars
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Shahid Faghihi hospital, Zand St., Shiraz City
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mghahar@sums.ac
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ghahartars
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Shahid Faghihi hospital, Zand St., Shiraz t
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mghahar@sums.ac
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Malek Khedri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Shahid Faghihi hospital, Zand St., Shiraz City
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
M.Khedri1399@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available