Evaluating the efficacy of nanoliposomal amphotericin B in patients with treatment-resistant dermatophytosis
Design
A controlled, parallel-group, single-blind, randomized, phase 1 clinical trial was conducted on 75 patients with treatment-resistant dermatophytosis. Randomization was performed using Random Allocation software.
Settings and conduct
"The present study is a single-blind randomized clinical trial conducted on 75 patients with treatment-resistant dermatophytosis, who will be recruited from Tuba Baghban Specialty Clinic and cosmetic dermatology clinics in Sari, Iran, between 2024-2025.
Participants/Inclusion and exclusion criteria
"Inclusion Criteria: Patients with treatment-resistant dermatophytosis
Exclusion Criteria: Children, infants, pregnant women, and individuals who have received antifungal therapy within the past week."
Intervention groups
Group 1: Patients with treatment-resistant Dermatophytosis, who will receive nanoliposomal amphotericin B.
Group 2: Patients with treatment-resistant Dermatophytosis, who will receive both nanoliposomal amphotericin B and itraconazole.
Group 3: Patients with treatment-resistant dermatophytosis, who will receive itraconazole (200 mg/day for 4 weeks) as the control group.
Main outcome variables
Complete recovery of clinical symptoms Negative mycological criteria: negative result in direct examination or culture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240711062393N2
Registration date:2025-06-07, 1404/03/17
Registration timing:prospective
Last update:2025-06-07, 1404/03/17
Update count:0
Registration date
2025-06-07, 1404/03/17
Registrant information
Name
Mahdi Abastabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3321 7501
Email address
mabastabar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2026-01-21, 1404/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the efficacy of topical nanoliposomal amphotericin B in individuals with treatment-resistant dermatophytosis.
Public title
Evaluation of the effect of nanoliposomal amphotericin B in the treatment of patients with resistant dermatophytosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with treatment-resistant Dermatophytosis
Exclusion criteria:
Neonates and children range from 0 to 19 years
Pregnant mothers
Age
From 20 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization
For randomization, the block randomization method will be used.
Participants are divided into small blocks (e.g., 4 or 6 individuals per block), with an equal number assigned to each group within each block.
In this study, the unit of randomization is individual, as each patient is independently assigned to one of the groups.
The Random Allocation software is used to generate the random sequence.
Implementation mechanism:
The block size and number of blocks are determined randomly and unpredictably by the software.
After generating the sequence, patients are assigned to different groups based on the produced numbers.
Single-Blinding
Participants are unaware of which group they are in (nanosomal amphotericin B + itraconazole vs. nanosomal amphotericin B alone).
Researchers and assessors are aware of the treatment type.
Allocation Concealment
To prevent selection bias, it must be ensured that researchers are unaware of future patient assignments before enrollment.
Methods include:
Sealed opaque envelopes: Random numbers are placed in sealed, non-transparent envelopes.
Electronic system: The Random Allocation software determines the treatment group only after patient registration.
In this study: The software is used, so allocation remains concealed until the moment of patient enrollment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Simultaneously, the participants receive information regarding conducting a research study and complete the consent form; however, the type of gel (simple or nano form) will remain concealed from her.
Placebo
Not used
Assignment
Factorial
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
Moalem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2025-04-07, 1404/01/18
Ethics committee reference number
IR.MAZUMS.REC.1404.020
Health conditions studied
1
Description of health condition studied
Dermatophytosis is an inflammatory skin infection caused by dermatophyte fungi including Trichophyton, Microsporum, Epidermophyton, Lophophyton, Nannizzia, Parathion, and Arthroderma.
ICD-10 code
B35
ICD-10 code description
Dermatophytosis
Primary outcomes
1
Description
Percentage of Individuals with treatment-resistant dermatophytosis
Timepoint
Patients are evaluated at the beginning of the study
Method of measurement
Assessing lesion size, itch, and inflammation based on observation.
2
Description
Complete clinical response
Timepoint
Patients are evaluated after 2 and 4 weeks of treatment
Method of measurement
Assessing improvement of lesion size, itch, and inflammation based on the questionnaire scoring
3
Description
No response to treatment
Timepoint
Patients are evaluated after 2 and 4 weeks of treatment
Method of measurement
Assessing improvement of lesion size, itch, and inflammation based on the questionnaire scoring
4
Description
Independent variable-Nano-Liposomal Amphotercin b drug
Timepoint
Patients are evaluated after 2 and 4 weeks of treatment
Method of measurement
Patient grouping (drug-receiving group vs. control)
5
Description
Dependent variable-effectiveness
Timepoint
Patients are evaluated after 2 and 4 weeks of treatment
Method of measurement
Clinical outcomes
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Patients with treatment-resistant dermatophytosis (non-onychomycosis) who will receive nanoliposomal amphotericin B. Sina Ampholish 0.4% ointment is used twice a day for 4 weeks.
Category
Treatment - Drugs
2
Description
Group 2: Patients with treatment-resistant dermatophytosis, non-onychomycosis, who will receive nanoliposomal amphotericin B and itraconazole. Sina Ampholish 0.4% ointment is used twice a day, and itraconazole 200 mg tablet is taken once a day for 4 weeks
Category
Treatment - Drugs
3
Description
Control group: Patients with treatment-resistant dermatophytosis (non-onychomycosis) who will receive itraconazole (200 mg per day for 4 weeks) will serve as the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Specialized Clinic (Tuba) & Baran Clinic, Sari, Iran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mahdi Abastabar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
Mazandaran University of Medical Sciences, Valiasr Highway (AJ) Entrance, Juibar Rd., Imam Sq. (RA), Sari, Mazandaran Province, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
marieh.rajabalian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahdi Abastabar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
Mazandaran University of Medical Sciences, Valiasr Roadway Entrance, Juibar Road, Imam Square, Sari, Mazandaran Province, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahdi Abastabar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
Mazandaran University of Medical Sciences, Valiasr St. Entrance, Juibar Rd., Imam Sq., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
mabastabar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Contributors' data in the study is shareable once it is unidentifiable.
When the data will become available and for how long
The access period begins six months after the results are published.
To whom data/document is available
Researchers who are working at universities
Under which criteria data/document could be used
This information is only for comparison with similar research
From where data/document is obtainable
The information provided is only intended for comparison with similar research
What processes are involved for a request to access data/document
Project data sets will be housed on the website and/or the file transfer protocol site created for the study, and all data sets will be password-protected. Project Principal Investigators will have direct access to their own site’s data sets and access to other sites' data by request. To ensure confidentiality, data dispersed to project team members will be blinded to any identifying participant information