Evaluate the efficacy of topical solution of cetirizine in prevention and treatment of androgenetic alopecia
Design
in this study 40 patients with mild to moderate androgenetic alopecia referring
to the center of skin and leprosy are selected.participants are randomly in one of the two groups minoxidil or cetirizine .
Settings and conduct
the study conducted on all patients with mild to moderate androgenetic alopecia referred to the center of research and training in skin and leprosy .the study is randomized parallel single blind (patient) .patients in both treatment groups will use topical formulation with similar physical appearance and packaging.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male patients at the age of 18 to 49 years;
Male pattern hair-loss should be at 2,3,4 in Norwood Scale;
Signed informed consent voluntarily and knowingly;
Exclusion criteria:
History of allergy to Cetirizine or Minoxidil;
Use of 5-alpha reductase inhibitor in the last year;
Use of Isotretinion over the past year;
Use of nutritional supplement and herbal remedies for hair growth in the last 3 months;
Chemotherapy in the last year;
Scalp is exposed to radiation in the past year;
History of uncontrolled Blood Pressure;
History of Hypotension;
Taking systemic Steroid for more than 14 days in the last 2 months.
Intervention groups
Intervention group: using cetirizine topical solution, twice a day in hair- loss areas for 4 months .
Control group: using minoxidil topical solution, twice a day in hair- loss areas for 4 months.
Main outcome variables
hair count ; hair density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N3
Registration date:2018-03-04, 1396/12/13
Registration timing:registered_while_recruiting
Last update:2018-03-04, 1396/12/13
Update count:0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-07-05, 1397/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and evaluation of topical solution of Cetirizine in prevention and treatment of Androgenetic Alopecia
Public title
Effect of topical solution of Cetirizine on Androgenetic Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Males st the age of 18 to 49 years
Male pattern hair-loss should be at 2,3,4 in Norwood Scale
Signed informed consent voluntarily and knowingly
Exclusion criteria:
History of allergy to Cetirizine or Minoxidil
Using 5-alpha reductase inhibitor in the last year
Using Isotretinion over the past year
Using nutritional supplement and herbal remedies for hair growth in the last 3 months
Chemotherapy in the last year
Scalp has been exposed to radiation in the past year
History of uncontrolled Blood Pressure
History of Hypotention
Taking systemic Steroid for more than 14 days in the last 2 months
Age
From 18 years old to 49 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
By using the random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study patients are blind to the type of intervention they receive. Patients in both treatment groups will use topical formulation with similar physical appearance and packaging.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Pharmaceutical Sciences branch , Islamic Azad University
Street address
Pharmaceutical sciences branch , Islamic Azad University, Yakhchal street , Shariati street , Tehran
City
tehran
Province
Tehran
Postal code
193956466
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.IAU.PS.REC.1396.136
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
hair count
Timepoint
Before intervention , two months later, 4 months later
Method of measurement
fotofinder trichoscale
2
Description
hair density
Timepoint
Before intervention , two months later, 4 months later
Method of measurement
fotofinder trichoscale
Secondary outcomes
1
Description
anagen -telogen hair percantage
Timepoint
Before intervention , two months later, 4 months later
Method of measurement
fotofinder trichoscale
2
Description
number and density of vellus hair to terminal hair
Timepoint
Before intervention , two months later, 4 months later
Method of measurement
fotofinder trichoscale
Intervention groups
1
Description
Intervention group: using Cetirizine topical solution, twice a day in hair- loss areas for 4 months.
Category
Treatment - Drugs
2
Description
Control group: using minoxidil topical solution, twice a day in hair- loss areas for 4 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of research and training in skin disease and leprosy
Full name of responsible person
Saman Ahmad Nasrollahi
Street address
no.415 ; Taleghani Ave; Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
sammannasrol@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Center of research and training in skin diseases and leprosy
Full name of responsible person
Alireza Firouz
Street address
no. 145 ;Taleghani ave; Tehran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
Alifirouz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center of research and training in skin diseases and leprosy
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
Islamic Azad University
Full name of responsible person
Delaram Hossein Mostafa
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
no. 5; 46 alley; Asad abadi ave; Tehran
City
Tehran
Province
Tehran
Postal code
1436764963
Phone
+98 21 8805 9151
Email
delaram_m72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Delaram Hossein Mostafa
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
no.5 ; 46 alley; asad abadi ave; Tehran
City
Tehran
Province
Tehran
Postal code
1436764963
Phone
+98 21 8805 9151
Email
delaram_m72@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Delaram Hossein Mostafa
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
no.5 ; 46 alley; asad abadi ave; Tehran
City
Tehran
Province
Tehran
Postal code
1436764963
Phone
+98 21 8805 9151
Email
delaram_m72@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available