Clinical trial of Comparison of the efficacy and safety of finasteride and hydroxy chloroquine on frontal fibrosing severity index in patients with frontal fibrosing alopecia
1. Finding appropriate and uncomplicated treatment in patients with frontal fibrosing alopecia
2. Comparison of the efficacy and safety of finasteride and hydroxy chloroquine for treatment of frontal fibrosing alopecia
Design
A clinical trial with phase2 ,randomized. paralell groups is performed on 30 patients.
Settings and conduct
This study is a randomized clinical trial performed in the dermatology clinics and teaching hospitals affiliated to Esfahan university of medical science. Sampling is performed among patients referred to dermoscopy clinic affiliated to the Esfahan university of medical science and if they have the conditions to enter and leave the study are considered as an sample. And then randomly divided into two treatment groups in this study. Before starting treatment, patients are evaluated in 3 ways:
1. Disease activity index
2. Photography
3. Trichoscopy
After 2, 4 and 6 months from the start of treatment, patients are re-evaluated for the above.
Participants/Inclusion and exclusion criteria
New cases with FFA who have not yet received any medication; patients who have previously received systemic therapy and have not received systemic medication for at least the last three months and according to clinical and dermoscopic criteria, their disease is active; patients treated with topical medication and according to clinical and dermoscopic criteria, their disease is active
Intervention groups
1-Finasteride (2.5mg/day orally)will be administered in one group(15 patients) and for 6 months.
2-Hydroxy choloroquine (400mg/day orally)will be administered in one group(15 patients) and for 6 months.
Main outcome variables
1. Frontal fibrosing alopecia severity index
2. Standardized global photography
3.Tricoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210513051276N1
Registration date:2021-06-03, 1400/03/13
Registration timing:prospective
Last update:2021-06-03, 1400/03/13
Update count:0
Registration date
2021-06-03, 1400/03/13
Registrant information
Name
maryam farokhshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 3129
Email address
farokhshahimaryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Comparison of the efficacy and safety of finasteride and hydroxy chloroquine on frontal fibrosing severity index in patients with frontal fibrosing alopecia
Public title
The effect of finasteride and hydroxy chloroquine on frontal fibrosing alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
New cases with FFA who have not yet received any medication.
Patients who have previously received systemic therapy and have not received systemic medication for at least the last three months and according to clinical and dermoscopic criteria, their disease is active.
Patients treated with topical medication and according to clinical and dermoscopic criteria, their disease is active
Exclusion criteria:
Pregnancy or lactation
History of hypersensivity due to hydroxychloroquine or finasteride
Patients with severe blood dyscrasia and liver dysfunction
Patients with retinopathy
Personal history or family history of breast cancer
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is performed among patients referred to dermoscopy clinic affiliated to the esfahan university of medical science and if they have the conditions to enter and leave the study are considered as an sample.
Random function of Excel software based on patient file number will be used for randomization. Patients with frontal fibrosis alopecia are entered in Excel according to the file number and are divided into two groups of finasteride and hydroxychloroquine based on the random button. Once the file numbers are entered in Excel, then select the repeating each number option and select 15 repeating the sequence. In this way, 30 will be produced. Then, from the data analysis command, the random number is selected. It is clear that the repetition of each number occurs once in each group, for a total of two groups of 15 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
AL Zahra Hospital, Dermatology Department, Sofeh Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174645731
Approval date
2021-03-19, 1399/12/29
Ethics committee reference number
IR.MUI.MED.REC.1399.1194
Health conditions studied
1
Description of health condition studied
Frontal fibrosing alopecia
ICD-10 code
L66.9
ICD-10 code description
Cicatricial alopecia, unspecified
Primary outcomes
1
Description
Frontal fibrosing alopecia severity index
Timepoint
Before and after intervention
Method of measurement
Checklist
2
Description
Standardized global photography
Timepoint
Before and after intervention
Method of measurement
Based on scoring by two dermatologist
3
Description
Tricoscopy
Timepoint
Before and after intervention
Method of measurement
Based on scoring by two dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
A group of 15 patients are treated with finasteride tablets of 2.5 mg daily for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group: A group of 15 patients treated with hydroxychloroquine 400 mg daily for 6 months.
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
Dissemination of data that has nothing to do with the personality and identity of the participants in the study and are merely the consequences of the study.
When the data will become available and for how long
Start the access period after the article is published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions, after their authentication by the relevant university.
Under which criteria data/document could be used
The data can only be used for research and writing review articles.
From where data/document is obtainable
The author will be available via the email and university phone number mentioned in the article.
What processes are involved for a request to access data/document
Access to the data is granted if it is found that the data has been requested for non-industrial and non-commercial use.