Determination and comparison of the therapeutic effect of topical finasteride with oral finasteride in patients with androgenetic alopecia.
Design
The study is a randomized, controlled, blinded investigator, phase 3 trial
parallel (assignment of two groups). restricted randomization method, the permuted block randomization type will be used, and a random sequence will be created using the random allocation software. Replacement blocks of 4 are assigned to two treatments (groups A, b). At least 14 people were considered for each group.
Settings and conduct
Patients are randomly selected from patients who refer to the dermatology clinic of Shahid Faqihi in Shiraz and receive drug treatment for 6 months and are examined after 3 months and at the end of 6 months. The collection tool in this study is a checklist that the results of the treatment evaluation will be recorded at the beginning of the study, at the end of the 3rd and 6th month. The assessment of the process of improving hair growth from the point of view of the patient and the doctor based on clinical judgment in terms of hair density (weak and medium and good and excellent) will be done
Participants/Inclusion and exclusion criteria
inclusion: Having androgenic alopecia grade 2 to 5 based on the Norwood Hamilton classification in men؛ age above 18 years, having androgenic alopecia grade 2 to3 according to ludwig grading in women؛ menopausal women or women over18 years of age who use IUD orTL؛ informed consent to participate in the study
exclusion: history of allergic reaction to finasteride drug؛ pregnancy or trying to have a child؛ active infectionor any scratches and wounds in the scalp
Intervention groups
Group A will use finasteride in oral form and group B will use the topical form of finasteride nano liposomal solution 0.1% once a day.
Main outcome variables
The rate of improvement of hair loss; dht serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220901055844N1
Registration date:2023-12-19, 1402/09/28
Registration timing:prospective
Last update:2023-12-19, 1402/09/28
Update count:0
Registration date
2023-12-19, 1402/09/28
Registrant information
Name
Roya Radanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 1542
Email address
roya.radanfar72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-08-02, 1403/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the therapeutic effect of topical finasteride with oral finasteride in patients with androgenetic alopecia .
Public title
A comparative study of the therapeutic effect of topical finasteride with oral finasteride in patients with androgenetic alopecia .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having androgenic alopecia grade 2 to 5 based on the Norwood Hamilton classification in men
Age above 18 years
Not receiving treatment for androgenic alopecia during the last 3 months
Having androgenetic alopecia grade 2 to 3 according to Ludwig grading in women
Menopausal women or women over 18 years of age who use IUD or TL.
Informed consent to participate in the study
Exclusion criteria:
Failure to sign the consent form.
History of allergic reaction and anaphylaxis to Finasteride drug
Pregnancy or trying to have a child.
Individual history of infertility
Active infection or any scratches and wounds in the scalp
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
The design will be done in parallel (assignment of two groups). The randomization of the design will be done by the restricted randomization method, the permuted block randomization type will be used, and a random sequence will be created using the random allocation software. Replacement blocks of 4 are assigned to two treatments (groups A, b). So that at least 14 people are treated with oral finasteride and at least 14 people are treated with topical finasteride.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done in such a way that two types of drugs will be provided to the patients by the second colleague of the resident of the project, and the collection of information before, three months after and 6 months after will be done by the resident of the project, who is not aware of the type of drug. Plan; The data with the name of the group will be provided to the consultant professor
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shahid fagihi hospital, zand ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.SUMS.MED.REC.1402.031
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
The rate of improvement in hair growth
Timepoint
evaluating the improvement of hair loss at the beginning of the study and at the end of 3months and at the end of 6months
Method of measurement
Comparison of the effect of topical finasteride with oral finasteride in the treatment of androgenic hair loss. how to measure this variable is with a questionnaire.
2
Description
Serum Dihydrotestosterone
Timepoint
At the beginning of the study and at the end of 6 months
Method of measurement
by free blood sampling from the patient at the Motahari clinic in Shiraz byuse a lab kit to measure blood Dihydrotestosterone
3
Description
Investigation of drug side effects
Timepoint
At the end of the 3rd month and the end of the 6th month
Method of measurement
At each stage, unwanted side effects, including redness, itching and symptoms of drug reaction, as well as breast tenderness, and symptoms of sexual dysfunction, are asked from the patients and recorded in the questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group A, finasteride drug in oral form will be used. In this group, finasteride 1 mg tablets will be prescribed daily for male patients and 5 mg tablets manufactured by Ati Pharmed pharmaceutical company for female patients. In group B, the topical form of finasteride nano liposomal solution 0.1% will be used once a day. Finasteride nanoliposomes were prepared using the formulation prepared in the approved design and thesis of Dr. Mehyar Dari Gio under number 940768 at Mashhad University of Medical Sciences.will be. Then the properties of finasteride-containing nanoliposomes including particle size and zeta potential by DLS device.Morphology will be checked by electron microscope and stability on day 0, 1, 3, 6, 12 and 24 months at ambient temperature and 4 degrees, 25 and 37 degrees (according to ICH protocol.)which is sprayed on the surface of the area by the plastic applicator that comes with the product and massaged gently. Also, the patient will be warned not to wash the area for several hours after use, and to spray a little amount on the scalp and avoid a large amount. In order to use the same drug for the same patient on different days or for different patients, standard sprays were used, where every 12 to 15 puffs is equivalent to using 1 ml of the desired lotion.The duration of treatment in both groups is 6 months. And the visits of patients in both groups will be done at the beginning of the study and in the 3rd month and in the 6th month. Medicines are sent to the laboratory of Motahari Clinic in Shiraz for blood sampling, and the serum DHT levels will be checked for free before and after the start of treatment and after the end of 6 months of treatment. In order to comply with the blinding in the study, the resident is responsible for visiting and following up the response to the treatment in two groups and collecting information, they will not know the type of treatment given to the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi Hospital
Full name of responsible person
Roya Radanfar
Street address
Shahid Faghihi Hospital, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 915 035 1139
Email
Roya.Radanfar72@gmail.com
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
Mohammadhashem Hashempur
Street address
Shahid Faghihi Hospital, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Web page address
https://faghihi.sums.ac.ir
Grant name
Grant code / Reference number
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ghahartars
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shahid Faghihi Hospital, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 917 313 9214
Email
Mehdighahartars@yahoo.com
Web page address
https://faghihi.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roya Radanfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahid Faghihi Hospital, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 915 035 1139
Email
Roya.Radanfar72@gmail.com
Web page address
https://faghihi.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roya Radanfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahid Faghihi Hospital, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 915 035 1139
Email
Roya.Radanfar72@gmail.com
Web page address
https://faghihi.sums.ac.ir
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
The results of the study are shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data of the study is made available to all people who are engaged in this industry
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
via email Roya.Radanfar72@gmail.com
What processes are involved for a request to access data/document
From the time of sending the request by email for one month