The aim of this study is to reveal the efficacy and safety of topical dustasteride in treatment of female pattern hair loss
Design
paitents were randomized by block randomization into two groups
Settings and conduct
This study include female patients with AGA who visitied Razi dermatological Hospital in 2023-2024 and were randomized into two groups by block randomization. One group receive only topical dutasteride for six months and the other group receive both topical dutasterdie for six months and four sessions of Erbium Yag Laser.
Participants/Inclusion and exclusion criteria
Inclusion criteria
-Age more than 18-year-old
-Female patients
-Female pattern hair loss Ludwig grade scale 1-3
exclusion criteria
-Past history of treatment of AGA in the last 3 months
-Addicted or Alcoholism
-Past history of hair transplant
-systemic diseases or dermatological diseases that may affect hair growth
-Hypersensitivity to topical dutasteride
-Sexual dysfunction
-Concurrent medication of AGA
-Lactation & Pregnancy
Intervention groups
The included patients in this study will be randomized into two group according to block randomization. An area of the scalp with the lower hair density is marked, an initial basic photography and initial trichoscopic studies will be conducted, then at 3 and 6 months interval.
one group receive topical dutasteride solution 0.1%ml alone every night
the other gruop receive Dutasteride solution and four sessions of laser therapy every 4 weeks
Main outcome variables
The main outcome measures is an increase in hair density and an increase in trichoscopic parameters.
General information
Reason for update
Acronym
AGA
IRCT registration information
IRCT registration number:IRCT20241003063247N1
Registration date:2024-12-02, 1403/09/12
Registration timing:registered_while_recruiting
Last update:2024-12-02, 1403/09/12
Update count:0
Registration date
2024-12-02, 1403/09/12
Registrant information
Name
Saman Al Zahawi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 922 625 6180
Email address
samanzahawi88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-18, 1403/08/28
Expected recruitment end date
2024-12-18, 1403/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The safety and efficacy of topical Dutasteride in comparison to topical Dutasteride & laser therapy in management of female pattern hair loss
Public title
The safety and efficacy of topical Dutasteride in comparison to topical Dutasteride & laser therapy in management of female pattern hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 year old
clinical and trichoscopic diagnosis of female pattern hair loss
female patients
Female pattern hair loss grade 1-3 ludwig scale
Exclusion criteria:
Past history of treatment of AGA in the last three months
Alcoholism or addicted
Past history of hair transplant
systemic diseases or dermatological diseases that may affect hair regrowth
Sensitivity to topical dutasteride
Sexual dysfunction
Current treatment for AGA
Lactation and pregnancy
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The included patients in this study will be randomized into two group according to block randomization. before treatment, area s of low hair density in the scalp will be marked with tatto by two dermatologists, hair density, hair number will be assesed by trichoscopy and photo before treatment and after treatment will be compared.
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
Research Ethics Committees of School of Medicine -Tehran University of Medical Science
Street address
Razi Hospital, Vahdat-e- eslami square, Tehran, Iran zip code: 1199663911
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.378
Health conditions studied
1
Description of health condition studied
Female pattern hair loss
ICD-10 code
L64.8
ICD-10 code description
Other androgenic alopecia
Primary outcomes
1
Description
Number and percentage of terminal and vellous hair, in addition to diameter of the hair terminals.
Timepoint
Number and percentage of terminal and vellous hair, in addition to diameter of the hair terminals before intervention, 3 months after intervention and lastly 6 months after intervention.
Method of measurement
Trichoscopy
Secondary outcomes
1
Description
overall increase in hair density
Timepoint
initially, after 3 months and lastly after 6 months
Method of measurement
trichscopy
Intervention groups
1
Description
First interventional group: Dutasteride solution 60/ml which contain the active ingredient Dutasteride with a concentration of 0.1% mg/ml was prepared by pharmacists in Tasnim Pharmaceutical Company. Each milliliter of the solution to be applied every night to the vertex and areas with the lowest hair density. The duration of the trial is six months. complete details will be provided to all patients regarding the side effects of the solution and they will be inquired about the possible side effects every month. basic photographic and trichoscopic assessment will be done, and repeated in 3 months and 6 months follow up period.
Category
Treatment - Drugs
2
Description
second interventional group: Dutasteride solution 60/ml which contain the active ingredient Dutasteride with a concentration of 0.1% mg/ml was prepared by pharmacists in Tasnim Pharmaceutical Company. Each milliliter of the solution to be applied every night to the vertex and areas with the lowest hair density. The duration of the trial is six months. complete details will be provided to all patients regarding the side effects of the solution and they will be inquired about the possible side effects every month. basic photographic and trichoscopic assessment will be done, and repeated in 3 months and 6 months follow up period. in addition, Photona Laser of the scalp hair was conducted for four sessions, four weeks apart.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital/ Tehran University of Medical Science
Full name of responsible person
Saman Alzahawi
Street address
Razi Hospital, Vahdat-e- eslami square, Tehran, Iran zip code: 1199663911
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 922 625 6180
Email
samanzahawi88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mariam Nasimi
Street address
Razi Hospital, Vahdat-e- eslami square, Tehran, Iran zip code: 1199663911
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 912 843 5986
Email
nsm.maryam@gmail.com
Web page address
https://en.tums.ac.ir
Grant name
Tehran University of Medical Science
Grant code / Reference number
٠٠٠٠٠٠٠٠٠٠
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
50
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
Saman Alzahawi
Position
Medical Doctor/ Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat-e- eslami square, Tehran, Iran zip code: 1199663911
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 922 625 6180
Email
samanzahawi88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Alzahawi
Position
Medical Doctor/ Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat-e- eslami square, Tehran, Iran zip code: 1199663911
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 912 261 2946
Email
samanzahawi88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Alzahawi
Position
Medical Doctor/ Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat-e- eslami square, Tehran, Iran zip code: 1199663911
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 922 625 6180
Email
samanzahawi88@gmail.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
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
Data Available 6 months after publication
To whom data/document is available
Data only available for people working in academic institutions
Under which criteria data/document could be used
Data will be shared to compare similar articles, and requests will be reviewed and approved by the supervisor of this article.
From where data/document is obtainable
Razi Dermatology Hospital/ Photophinder Department
What processes are involved for a request to access data/document
Getting Approval from the photophinder department
Getting approval from the head of dermatological department
Getting approval from the supervisor of this study
The needed time to get the overall approval is nealy one week