To compare the safety and efficacy of BT DERMA plus standard treatment versus standard treatment alone in dermatophytosis patients.
Design
This is a non-randomized, phase 2/3 clinical trial on 30 patients with dermatophytosis. All patients will receive oral itraconazole 200 mg once daily and ketoconazole 2% antifungal shampoo. For topical treatment, one lesion will receive clotrimazole 1% cream alone, while another lesion will receive both clotrimazole 1% and BT DERMA creams simultaneously.
Settings and conduct
Patient recruitment will be conducted at the specialized dermatology clinic of Dr. Khodashenas, the principal investigator. The study will include 30 patients, and no blinding will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmed fungal skin infection (dermatophytosis);
At least two lesions in two distinct anatomical sites.
Exclusion criteria:
Current or prior immunosuppressive medication use;
Secondary bacterial infection;
Recent or concurrent antifungal use;
Concomitant drugs interfering with itraconazole absorption or metabolism
Intervention groups
Intervention group 1: one lesion on one side of the limb will receive clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed.
Intervention group 2: Another lesion on the opposite side of the same limb will receive both clotrimazole 1% cream and BT DERMA cream twice daily for at least 4 weeks, continuing until improvement is observed.
If multiple lesions are present, the remaining lesions will be treated with clotrimazole 1% cream only.
Main outcome variables
The degree of erythema, itching, and scaling of skin lesions;
KOH test result
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240304061158N6
Registration date:2026-07-07, 1405/04/16
Registration timing:prospective
Last update:2026-07-07, 1405/04/16
Update count:0
Registration date
2026-07-07, 1405/04/16
Registrant information
Name
fariba nemati
Name of organization / entity
Behpad Teb Iranian
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6890
Email address
info@behpadti.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy and Safety of Adding Topical BT DERMA to Standard Therapy versus Standard Therapy Alone in Patients with Dermatophytosis
Public title
Efficacy of BT DERMA product in the treatment of cutaneous fungal infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of dermatophytosis (fungal skin infection) by positive potassium hydroxide (KOH) test.
Subjects who have at least two lesions at two different anatomical locations
Provision of informed consent to participate in the study
Exclusion criteria:
Pregnant and lactating women
Patients with renal, hepatic, or heart failure
History of hypersensitivity to the study medications
Patients who have received systemic immunosuppressive drugs within two weeks prior to study entry
Patients with secondary bacterial infection
Patients taking medications that affect the absorption (e.g., antacids) or metabolism (e.g., anticonvulsants) of itraconazole
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Dermatophytosis lesion
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The study will be conducted using a split-body design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2025-12-08, 1404/09/17
Ethics committee reference number
IR.SHAHED.REC.1404.004
Health conditions studied
1
Description of health condition studied
Skin fungi (dermatophytes)
ICD-10 code
B35
ICD-10 code description
Dermatophytosis
Primary outcomes
1
Description
Erythema
Timepoint
Clinical evaluation was performed on days 0, 7, 14, 21, and 28 after study initiation.
Method of measurement
Visual Analogue Scale
2
Description
Pruritus
Timepoint
Clinical evaluation was performed on days 0, 7, 14, 21, and 28 after study initiation.
Method of measurement
Visual Analogue Scale
3
Description
Scaling
Timepoint
Clinical evaluation was performed on days 0, 7, 14, 21, and 28 after study initiation.
Method of measurement
Visual Analogue Scale
4
Description
KOH test result
Timepoint
Days 0 and 28 after study initiation
Method of measurement
Performing KOH test
Secondary outcomes
1
Description
Safety
Timepoint
7rd, 14th, 21th, 28nd days after starting the study
Method of measurement
Doctor examination and patient report
Intervention groups
1
Description
Intervention group: Patients will receive oral itraconazole 200 mg once daily plus ketoconazole 2% shampoo (with each bath, at least twice and up to five times weekly). For topical treatment, one lesion on one side of the limb will receive BT DERMA and clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive oral itraconazole 200 mg once daily plus ketoconazole 2% shampoo (with each bath, at least twice and up to five times weekly). For topical treatment, one lesion on one side of the limb will receive clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Khodashenas dermatology clinic
Full name of responsible person
Zohreh Khodashenas
Street address
BRT 32th station, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1418863981
Phone
+98 903 111 9779
Email
zohrehkhodashenas@ymail.com
2
Recruitment center
Name of recruitment center
Mostafa Khomeini Hospital
Full name of responsible person
Zohreh Khodashenas
Street address
No. 9, Italia Street., Felelestin Street, Keshavarz Boulevard, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8897 5477
Fax
+98 21 8896 3739
Email
info@mkht.ir
Web page address
http://mkht.ir/en
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behpad Teb Iranian
Full name of responsible person
Fariba Nemati
Street address
Unit 22, Fanavaran Building, Danesh 4, Pardis Technology Park, 20th Kilometer of Damavand Road, Tehran, Iran
City
Pardis
Province
Tehran
Postal code
1654120611
Phone
+98 21 6642 6890
Fax
+98 21 4066 0468
Email
info@behpadti.com
Web page address
https://behpadti.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behpad Teb Iranian
Proportion provided by this source
85
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Shahed university Immune Response Regulation Research Center
Full name of responsible person
Azade Rashidi
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
immunoreg@shahed.ac.ir
Web page address
https://irrc.shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed university Immune Response Regulation Research Center
Proportion provided by this source
15
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
Immunoregulation Research Center
Full name of responsible person
Azadeh Rashidi
Position
master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
a.rashidi@shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin clinic of Dr. Khodashenas
Full name of responsible person
Zohreh Khodashenas
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Station 32, Valiasr Street.
City
Tehran
Province
Tehran
Postal code
1418863981
Phone
+98 903 111 9779
Email
zohrehkhodashenas@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Immunoregulation Research Center
Full name of responsible person
Azadeh Rashidi
Position
master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
a.rashidi@shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Ethical consideration about patient information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After publishing the final results, the study protocol, statistical analyzes and the informed consent form will be shared without mentioning the names of the individuals.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Domestic researchers
Under which criteria data/document could be used
To conduct review studies or advanced statistical analysis and bioinformatics
From where data/document is obtainable
Azadeh Rashidi (project coordinator-Immunoregulation research center-Shahed university)
azadehashidi025@gmail.com
What processes are involved for a request to access data/document
Submitting a request to the executor of the project, Mrs. Dr. khodashenas,Referral to the head of the center Shahed University research, Obtain university approval,Provision of data