Comparison the effect of topical cetirizine versus topical minoxidil on hair growth in women with female pattern hairloss
Design
Patients based on randomization software were divided into 2 groups each include 45 patient. and for 6 months they will be under treatment with topical cetirizin while the control group will be treated with topical minoxidil.
Settings and conduct
Patient is diagnosed by a dermatologist and by the use of randomization software patients were divided into 2 groups. tested group were given cetirizin 1% 1 ml to be used topically on the scalp. In the control group used a 2% minoxidil solution where 1 ml was used on the scalp. Patients were evaluated at the beginning 1st 3rd and 6th month of study the hair loss evaluation was based on shedding scale and sinclair scale as well as thickness and number of hair unit via tricoscopy. If patient during 3rd month didnt show any response they will be omitted from the study. Otherwise they ll continue the use of the solution until the 6th month then re evaluated by tricoscopy and then photographs will be taken then the data will be analyzed. Patients are who visited the dermatology clinic.
Participants/Inclusion and exclusion criteria
Female with female pattern hair loss without androgenetic hormonal imbalance disorders ,Who did not undergo any treatment inregard to hair loss for the last 6 months ,No other causes for hair loss such as inflammatory or scarring hair loss and also
Intervention groups
One group were given cetirizin 1% solution 1 ml to be used topically on the scalp. the other group used a 2% minoxidil solution where 1ml twice daily was used on the scalp.both for a period of 6 months.
Main outcome variables
Hair loss condition based on Sinclair scale and shedding scale
Study of density and thickness of hair by trichoscopy Measurement time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200521047536N1
Registration date:2021-01-05, 1399/10/16
Registration timing:retrospective
Last update:2021-01-05, 1399/10/16
Update count:0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
Seyed mohammad kazem Alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3291 1698
Email address
alavimk96@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical cetirizine versus topical minoxidil on hair growth in women with female pattern hairloss
Public title
The effect of topical cetirizine on hair growth in women with female pattern hairloss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female with female pattern hair loss without androgenetic hormonal imbalance disorders
Who did not undergo any treatment inregard to hair loss for the last 6 months
No other causes for hair loss such as inflammatory or scarring hair loss
Consent for entering into the research
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple, this method use simple randomization models such as random number table or computerized randomization for example assign each participant to intervention group or control group by random number table.
Allocation Concealment: A random number table using www.randomization.com
A random number table is a large collection from numbers that does not have a regular pattern and completely randomized was made in a form of a table. 45 sets each has 2 patients one is named patient 1 and the other one is patient 2. ln each set one Patient was given minoxidil and another patient was given cetirizine. Investigator randomly select patients and based on his or her number (1 or 2) the allocated medicine was given.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals under study, evaluators and analysts will be unaware of the intervention and control groups.A 60 ml container without label filled with either minoxidil or cetirizine was given to the patients and they were unaware of its contents. Evaluators and analysts will be unaware that data is related to minoxidil group or cetirizine group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of mashad university of medical sciences
Street address
Opposite to Daneshgah 18 St, Mashhad University of Medical Sciences, Deputy of Research and Technology of the University
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
ir.mums.medical.rec.1398.091
Health conditions studied
1
Description of health condition studied
female pattern anderogenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
situation of hair loss
Timepoint
at the begining 1st 3rd and 6th month
Method of measurement
sinclair scale and shedding scale
2
Description
evaluation of hair density and hair thickness
Timepoint
at the begining 1st 3rd and 6th month
Method of measurement
by tricoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: topical solution of 1% cetirizine 1 ml daily for 6 month
Category
Treatment - Drugs
2
Description
Control group: topical solution of 2% minoxidil 1 ml twice daily for 6 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Reza Hospital Hospital in Mashhad
Full name of responsible person
dr pouran layegh
Street address
The beginning of Daneshgah St, Mashhad, Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5726
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Opposite to Daneshgah 18 St, Mashhad University of Medical Sciences, Deputy of Research and Technology of the University
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed mohammad kazem alavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 65. kafi15 Ave. tabarsi62 Ave. tabarsi St
City
mashhad
Province
Razavi Khorasan
Postal code
9157794739
Phone
+98 25 3291 1698
Email
Alavimk961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr pouran layegh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Daneshgah st, Imam Reza hospital, Dermatology department
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51385430319
Email
Layeghpo@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Alavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 65. kafi15 Ave. Tabarsi 62 Ave. Tabarsi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9157794739
Phone
+98 25 3291 1698
Email
Alavimk961@mums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.