Formulation, physicochemical characterization and single-group phase II clinical trial with comparison before and after treatment to evaluate the efficacy and clinical safety of 5% phenytoin solution in improving androgenic hair loss
Measuring the effectiveness and clinical safety of 5% phenytoin solution in improving androgenic hair loss
Design
Single-group phase II clinical trial comparing before and after on 15 patients
Settings and conduct
The patient must go to the skin clinic of Rasool Hospital on the first day, the second month and the fourth month. On the first day, he will be visited by the study researcher and he will provide the study researcher with information such as underlying diseases and medications. In the following, if he meets all the entry criteria, he will be included in the study. Also, in this visit, a photograph is taken of a certain area of the head and sampling is done from three areas of the head (forty hairs). At the end of the first visit, the study drug will be prescribed and the method of use and possible side effects will be explained by the researcher. In the visit of the second month and the fourth month, he was visited by the study researcher. Also, in these two visits, photographs were taken of a certain area of the head and sampling was done from three areas of the head (forty strands of hair) and the patient expressed his level of satisfaction with He informs his doctor about the treatment process and the resulting changes.
Cooperation in this study lasts for four months, and during this period, the patient must visit the skin clinic of Rasool Hospital three times at intervals of two months. Each visit takes about 15 to 20 minutes.
Participants/Inclusion and exclusion criteria
A man aged between 18 and 50 years
Hair loss pattern based on Hamilton Norwood scale (II, III, IV)
Enjoying public health
Sign the consent form
Intervention groups
Improvement of androgenic hair loss by use 5% phenytoin solution twice a day.
Main outcome variables
The number of hairs in a specified area of the scalp
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190901044666N3
Registration date:2022-12-17, 1401/09/26
Registration timing:prospective
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Afsaneh Sadeghzadeh bazargan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
sadeghzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation, physicochemical characterization and single-group phase II clinical trial with comparison before and after treatment to evaluate the efficacy and clinical safety of 5% phenytoin solution in improving androgenic hair loss
Public title
The effect of 5% phenytoin solution in improving androgenic hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A man aged between 18 and 50 years
Hair loss pattern based on Hamilton Norwood scale (II, III, IV)
Sign the consent form
Enjoying general health
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences, School of Medicine
Street address
School of Medicine, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-12-05, 1401/09/14
Ethics committee reference number
IR.IUMS.REC.1401.682
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 number of hairs in a specified area of the scalp
Timepoint
At screening, 2 and 4 months after treatment
Method of measurement
ترجمه بیش از حد طولانی است و ذخیره نمیشودIn this examination, the area of the scalp is determined, and all examinations are performed on that area. The number of hairs at the beginning of the study, 2 months later and 4 months later is counted by the FotoFinder Tricoscale device. The tricoscale program from the FotoFinder device, a new program for documenting and quantifying hair loss, with the help of this software, all the basic parameters of hair growth and loss are calculated automatically. The parameters measured by this device are: calculating the number and density of hairs, the ratio and frequency of anagen and telogen hairs, the number and density of vulus and terminal hairs, determining hair thickness (optional), determining the number of follicular units. At the same time, the condition of the entire head hair is checked by a precision camera at the beginning of the study, 2 and 4 months after the treatment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment with 5% phenytoin solution twice a day for 4 months. For this purpose, the patient uses one milliliter of 5% phenytoin solution topically on his scalp.