1- Comparison of scarring in patients four months after treatment
2--Comparison of response score to treatment (anti-inflammatory effect) of patients two months after treatment
Design
Clinical trial with parallel groups, double-blind, randomized, on 40 patients.
Settings and conduct
In this interventional study, 40 patients referred to HaJDai Dermatology Clinic who are clinically suspected to have inflammatory Tinea Capitis and are confirmed through paraclinical studies are included in the study. Patients are randomly divided into two groups receiving Terbinafine plus placebo and receiving Terbinafine plus Prednisolone as the first and second groups, respectively. Photos of patients are taken at the beginning, during and at the end of the treatment. Patients are followed up initially for up to 4 weeks, weekly and then monthly for up to 4 months in terms of recovery, hair regrowth and possible complications. Treatment results will be reviewed by an impartial dermatologist. Information and treatment results are recorded in patients' files and analyzed by appropriate statistical methods.
Participants/Inclusion and exclusion criteria
Patients with inflammatory tinea capitis whose diagnosis is confirmed clinically and by smear and culture are included in the study. Patients who have already received corticosteroids, patients with immune system deficiency, pregnancy, breastfeeding, diabetic patients are not included in the study.
Intervention groups
Patients will be randomly assigned to 2 groups (Terbinafine and placebo alone or Terbinafine and Prednisolone combination group) in equal numbers.
Main outcome variables
Comparison of scar rate and treatment score in two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240225061105N1
Registration date:2024-03-04, 1402/12/14
Registration timing:registered_while_recruiting
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Hossein Kavoussi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 6643
Email address
hkavoussi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-15, 1402/08/24
Expected recruitment end date
2024-11-14, 1403/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Terbinafine alone with the Combination of Terbinafine and Prednisolone in the Treatment of Inflammatory Tina Capitis
Public title
Comparison of the Effect of Terbinafine alone with the Combination of Terbinafine and Prednisolone in the Treatment of Inflammatory Tina Capitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients with Inflammtory Tinea Capitis that have been confirmed Clinically and by Smear and Culture.
Exclusion criteria:
Patients who have Previosly recieved Corticosteroids
Patients with Immune System Deficiency
Pregnancy
Breastfeding
Diabetic patient
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this interventional study, patients referred to Hajdaiee dermatology clinic who are clinically suspected of inflammatory tinea capitis and are confirmed through para-clinical assessment are included in the study. Patients are randomly assigned to two groups receiving Terbinafine plus placebo and receiving Terbinafine plus Prednisolone, as first and second groups, respectively. Blocks of 4 (10 blocks) will be produced by the software by the statistical consultant. The registration of people is done by the dermatology assistant. People are assigned to two groups by the secretary of the group. The follow-up of the treatment results is done by a dermatologist who does not know about the allocation of people.The concealment mechanism is done by placing the blocks in the sealed envelopes, which is at the disposal of the secretary. Photo of the patients is taken at the beginning, during and at the end of the treatment. Patients are followed up initially weekly for up to 4 weeks, then monthly for up to 4 months in terms improvement, hair regrowth and possible complications. Treatment outcome will be reviewed by an independent dermatologist. Information and treatment results are recorded in patients' files and analyzed by appropriate statistical methods.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Patient and the Data Assessor (A Dermatologist who does not know the Allocation of Subjects) are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Questionnaire: Based on the clinical symptoms of redness, edema, pustule, scaling, itching, pain and hair loss, it will be scored. Scoring will be done from a minimum score of 0 to a maximum score of 7.
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: This group receives Terbinafine plus placebo. Based on the patient's weight, less than 25 kilograms 125 mg, between 25-45 kilograms 187.5 mg, and more than 45 kilograms 250 mg will be prescribed oral Terbinafine tablets (Binafine, Tehran Chemical Company) for four weeks.
Category
Treatment - Drugs
2
Description
Intervention group: This group receives combined treatment of Terbinafine and Prednisolone. Based on the patient's weight, less than 25 kilograms 125 mg, between 25-45 kilograms 187.5 mg, and more than 45 kilograms 250 mg will be prescribed oral Terbinafine tablets (Binafine, Tehran Chemical Company) for four weeks. For Prednisolone, for less than 10 years, 2.5 mg and for more than 10 years, 5 mg will be prescribed for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj Dayi Kermanshah Skin Specialist Clinic
Full name of responsible person
Hosein Kavousi
Street address
Haj Dai Skin Clinic , Golestan Crossroads , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714653113
Phone
+98 83 3845 3486
Fax
Email
soheilaazmoodeh88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
siroos jalili
Street address
Kermanshah University of Medical Sciences , Shahid Beheshti Boulevard , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3839 5885
Email
info@kums.ac.ir
Web page address
http://www.kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Information about the main outcome can be shared after de-identifying individuals.
When the data will become available and for how long
Immediately after printing the results.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Analysis on data related to age, sex, location of lesion and occupation of patients is allowed for retrospective studies.
From where data/document is obtainable
Dr. Soheila Azmoodeh, Dermatology Resident, Kermanshah University of Medical Sciences, Haj Daei Dermatology Clinic: Golestan Crossroad, Kermanshah, soheilaazmoodeh88@gmail.com
00989113582535
Dr. Hossein Kavousi, Dermatologist, Kermanshah University of Medical Sciences, Haj Dai Dermatology Clinic: Kermanshah, Golestan Crossroads, hkavousi@gmail.com
00989181322243
What processes are involved for a request to access data/document
The requester can request to receive data through email. It will receive the data after 2 days.