Investigating the effect of film-forming spray containing terbinafine (DermatoTreat) in the dermatophytosis treatment, A randomized double-blind clinical trial
A randomized, double-blind clinical trial, investigating the effectiveness, tolerance, and consumer acceptability of Dermatotrit topical antifungal spray (a product of Parsa Polymer Biotechnology Co., Ltd.) versus terbinafine ointment 1% in the treatment of Tinea pedis and Tinea versicolor
Design
Randomized, two arm parallel, double blinded, phase 3 clinical trial with two groups ( case and control) on 98 patients. Randomization is done using randomly modified blocks created by the software (block size = 4).
Settings and conduct
Volunteer patients will be systematically randomly treated with 1% terbinafine cream and Dermatotrit spray. Patients are evaluated at the beginning and 1, 2 and 4 weeks after the treatment. The place of the study is the Dermatology Department of Shahid Faghihi Hospital and the Medical Mycology Department of the Faculty of Medicine. This study will be a double-blind randomized clinical trial (researcher and participants).
Participants/Inclusion and exclusion criteria
Entry conditions:
Patients with dermatophytosis infection of the body or feet, which have been confirmed based on clinical symptoms observed by a dermatologist and mycological diagnostic tests (direct test and culture).
Non entry conditions:
Tinea pedis patients of moccasin type, Tinea capitis, Tinea with an extent of more than 20% and users of oral antifungal drugs in the two weeks before or during the study
Intervention groups
Case: treatment with Dermatotrit spray
Patients receive Dermatotrit experimental drug spray for daily topical treatment (twice daily) for upto 4 weeks.
Control: treatment with the standard Terbinafine cream 1%
Patients receive Terbinafine cream 1% for daily topical treatment (twice daily) for upto 4 weeks.
Main outcome variables
Effective treatment (fungal treatment and minimal symptoms)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230816059161N1
Registration date:2023-12-25, 1402/10/04
Registration timing:registered_while_recruiting
Last update:2023-12-25, 1402/10/04
Update count:0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Kamiar Zomorodian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 9411
Email address
zomorodian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of film-forming spray containing terbinafine (DermatoTreat) in the dermatophytosis treatment, A randomized double-blind clinical trial
Public title
Investigating the effect of DermatoTreat spray in the treatment of dermatophytosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the dermatophytosis patients who were diagnosed by physical exam by doctor or by routine mycological methods
Availability for the duration of the study (6 weeks)
Male or female, 18 years or older
Willingness to follow the study protocol
Not taking systemic antifungal drugs in the last month
Not using topical anti-fungal drugs or anti-fungal shampoo in 2 weeks before treatment
Insensitivity to terbinafine
Informed consent
Exclusion criteria:
Moccasin-type tinea pedis
Tinea capitis , tinea with an area of more than 20% of the body
Tinea resistant to previous treatments including oral treatment and Tinea incognito
Severe maceration of interdigital spaces
Severe fissuring
Prescribing or taking oral antifungal medication in the two weeks before or during the study
History of dry feet, cracks, fissures
Concomitant onychomycosis
Serous discharge or pus
Concomitant immunosuppressive or antimicrobial therapy
Failure to respond to treatment
Drug allergy
Failure to cooperate with the doctor
Pregnant and lactating women
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
An independent investigator, not directly involved in the trial, performed the randomization using permuted randomized blocks created by the software (block size = 4). Allocation concealment will also be performed by an independent investigator using sequentially numbered sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and physicians will be blinded to treatment group assignment throughout the study. Patients in the treatment group will be treated with an effective spray and an ineffective ointment, and patients in the control group will be treated with an effective ointment and an ineffective spray. The appearance, size, color and smell of ointments and sprays will be completely similar in both groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biological Research
Street address
Shiraz University of Medical Science, Karim Khan Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.SUMS.REC.1402.261
Health conditions studied
1
Description of health condition studied
Dermatophytosis
ICD-10 code
B35
ICD-10 code description
Dermatophytosis
Primary outcomes
1
Description
Effective treatment (fungal treatment and minimal symptoms)
Timepoint
In the beginning, 1, 2 and 4 weeks after the initiation of therapy
Method of measurement
Microscopic examination (direct smear exam) and clinical evaluation that is based on a total of 6 symptoms (skin peeling, vesiculation, erythema, fissure, soaking and itching) which is recorded by the physician.
Secondary outcomes
1
Description
The amount of side effects
Timepoint
In the beginning, 1, 2 and 4 weeks after beginning of therapy
Method of measurement
To check the safety of the treatment, we will calculate the amount of side effects as well as serious side effects and compare them between the two arms of the study using chi-square tests to check if there is a statistically significant difference or not.
2
Description
Effective treatment (fungal treatment and minimal symptoms)
Timepoint
4 weeks after beginning of therapy
Method of measurement
Negative mycological microscopic test (direct) and clinical evaluation that is based on a total of 6 symptoms (skin peeling, vesiculation, erythema, fissure, soaking and itching) which is recorded by the doctor.
3
Description
Patient satisfaction score
Timepoint
At the end of the treatment period
Method of measurement
Patients complete a short survey in the form of a questionnaire about their perception of the tolerability, effectiveness and comfort of the treatment on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = great, or they may respond with "no answer/prefer not to say". Scores for each treatment will be calculated and compared.
4
Description
Self-reported patient compliance
Timepoint
At the end of the treatment period
Method of measurement
In the questionnaire, patients are asked to estimate how many doses they have missed. Possible answers include none, 1-2, 3-4, 5-6, 7-8, or 9 or more. It shows whether there is a significant difference in the probability of adherence of patients to a treatment regimen or not.
Intervention groups
1
Description
Intervention group: treatment with DermatoTreat spray. Patients receive the developed Dermatotrit spray containing 1% Terbinafine Hydrochloride manufactured by Parsa Biotechnology Biotechnology Company for daily topical treatment (twice a day) for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Treatment with the standard Terbinafine cream 1%. Patients receive terbinafine ointment 1% (under the trade name Binafin 1%) manufactured by Tehran Chemical Factory for daily (twice) topical treatment for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology ward of Shahid Faghihi hospital
Full name of responsible person
Dr. Mahdi Ghahartars
Street address
Karim khan Zand Ave., Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 21 3235 1087
Fax
Email
FaghihiHsp@Sums.ac.ir
Web page address
https://faghihi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashem Hashempur
Street address
Karim khan Zand Ave., Shiraz University of Medical Science
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir/
Grant name
Shiraz University of Medical Sciences
Grant code / Reference number
28330
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
50
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
2
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Pedram Ebrahimnejad
Street address
Valie-Asr Blvd., Mazandaran University of Medical Science
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
Grant name
Grant code / Reference number
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
50
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
Kamiar Zomorodian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
School of Medicine, Shiraz University of Medical Science, Emam Hosein square, Karim khan Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5887
Email
zomorodian@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamiar Zomorodian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
School of Medicine, Shiraz University of Medical Science, Emam Hosein square, Karim khan Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5887
Email
zomorodian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamiar Zomorodian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
School of Medicine, Shiraz University of Medical Science, Emam Hosein square, Karim khan Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5887
Email
zomorodian@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
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
Title and more details about the data/document
The obtained results will be published in the form of articles and specialized congresses.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data can be obtained for the purpose of health promotion after sending a written request from the principal investigator.
From where data/document is obtainable
A written request for access to information should be sent to the email of the corresponding author or principal investigator.( Dr. Kamiar Zomorodian, zomorodian@sums.ac.ir)
What processes are involved for a request to access data/document
The request will be reviewed by the main researcher and if approved, will be sent to the applicant.