The Efficacy and side effects of oral dutasteride in the treatment of female pattern androgenetic alopecia compared with oral spironolactone in one sided clinical trial
The study of efficacy and complications of oral dutasteride in the treatment of patients with androgenetic alopecia
Design
Clinical trial with control group, parallel blind, randomized, phase 3 on 40 patients for 6 months.Randomization was carried out using block randomization
Settings and conduct
Patients referred to Razi Hospital are divided into two groups and randomly entered into one of the two groups. Before the treatment, the areas of the head that have the least density of hair in the vertex are determined by a tattoo on the scalp by a dermatologist, and before the start and during the treatment intervals and after that, we calculate the number of hairs in the same area using a trichoscope. And by taking pictures of the patients, a comparison is made. The specified area is selected in the minimum density area, and in the completely hairless areas, the edge of the hairless area is used. Patients are evaluated in each visit with global clinical photography and quantitative digital videotrichoscopic assessment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients with androgenetic alopecia (18-55 years old)
Exclusion criteria: 1) Intention to get pregnant 2) Sensitivity to the studied drug 3) History of breast cancer in the patient or first-degree relatives 4) Usage of other alopecia treatments in the past six months 5) having any skin or systemic diseases that affect hair growth
Intervention groups
Study group: taking oral Dutasteride 0.5 mg daily for 6 months.
Control group: taking oral spironolactone 100 mg daily for 6 months.
Main outcome variables
Sex؛ Age؛ Alopecia grade؛ Previous treatments؛ Duration of previous treatment؛ Therapeutic response؛ Total hair density (frontal and vertex) ؛Patient's quality of life؛ Number of villus and terminal hairs؛ Hair thickness؛ Complications of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231119060107N1
Registration date:2024-01-08, 1402/10/18
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
hussein kezzo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 901 111 7513
Email address
h_kezzo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy and side effects of oral dutasteride in the treatment of female pattern androgenetic alopecia compared with oral spironolactone in one sided clinical trial
Public title
The Efficacy of oral dutasteride in the treatment of female pattern androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAndrogenitic alopecia female patients
Exclusion criteria:
History of breast cancer
Usage of another AGA treatment in the past 3 months
Pregnancy or a plan to get ptegnant in the next year
Smoking or alchohol addiction
Drug reaction to dutasteride or spironolactone
History of hair transplant
History of any dermatologic or systemic disease that affect hair
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
we have Ten envelopes (blocks) Each envelope containing four papers (two Dutasteride, two spironolactone)
to determine every new patient's group, an envelope is selected randomly then a paper is randomly picked from the envelope which determines whether the patient will be in the study group or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The principal investigator who is responsible for grading the degree of baldness before and after treatment to photographic images and analysis of tricoscopy images is not aware of the medication used by the patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine, Tehran University of Medical Sciences
Street address
School of medicine, Pour sina street, Qods street, Enghelab street,Tehran
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2023-08-20, 1402/05/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.269
Health conditions studied
1
Description of health condition studied
Androgenitic alopecia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hair density increase in the vertex area
Timepoint
0, 3 months after treatment , 6 months after treament
Method of measurement
Trichoscopy report
2
Description
Hair thickness increase
Timepoint
0, 3 months after treatment , 6 months after treament
Method of measurement
Tricoscopy report
Secondary outcomes
1
Description
Alopecia grade
Timepoint
0, 3 months after treatment , 6 months after treament
Method of measurement
Sinclair scale
2
Description
Treatment response
Timepoint
3 months after treatment , 6 months after treament
Method of measurement
Questionnaire
3
Description
Patient quality of life
Timepoint
0, 3 months after treatment , 6 months after treament
Method of measurement
Dermatology life Quality Index questionnaire
4
Description
Drug complications
Timepoint
1 month after treatment, 3 months after treatment , 6 months after treament
Method of measurement
Questionnaire
5
Description
Villus and terminal hair number
Timepoint
0, 3 months after treatment , 6 months after treament
Method of measurement
Trichoscopy report
Intervention groups
1
Description
Intervention group: patients prescribed oral dutasteride 0.5 mg per day for 6 months
Category
Treatment - Drugs
2
Description
Control group: patients prescribed oral spironolactone 100 mg per day for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
hussein kezzo
Street address
Vahdate eslami St, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5562 0300
Email
nsm.maryam@gmail.com
Web page address
http://razihos.tums.ac.ir/en/Home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Deputy of research and technology, 6th floor, Tehran university of medical science, Qods street, Keshavarz blvrd, Tehran
City
Tehran
Province
Tehran
Postal code
1417613191
Phone
+98 21 8163 3685
Fax
+98 21 8898 9129
Email
Vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Ifa Etesami
Position
Assistant Professor Of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Square, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
ifa.etesami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ifa Etesami
Position
Assistant Professor Of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Square, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
ifa.etesami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hussein kezzo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Square, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
h_kezzo@yahoo.com
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
Not applicable
Title and more details about the data/document
Fotofinder and photography gallery in razi center
When the data will become available and for how long
After completing the study and for one year
To whom data/document is available
Razi hospital residents and other recearch centers students
Under which criteria data/document could be used
For research purposes and with respect to patiensts privacy
From where data/document is obtainable
Dr ifa itesami
Ifa.etesami@gmail.com
What processes are involved for a request to access data/document
Contact razi hospital research center
Ifa.etesami@gmail.com