compared efficacy of minoxidil, cetirizine and diclofenac in androgenic alopecia
Design
3 group,each group contain 18 peaple
Settings and conduct
At the begining we visited our patient in Loqman and Shohadaye Tajrish hospital.
Participants/Inclusion and exclusion criteria
men between 18 and 72 years old without systemic disease
Intervention groups
Control group:treatment with minoxidil solution 5%
First group:treatment with cetirizine 1%
second group:treatment with diclofenac 3%
Main outcome variables
effect of treatment with 3 drugs during 4 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043547N1
Registration date:2019-12-16, 1398/09/25
Registration timing:registered_while_recruiting
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Nastaran Namazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
nastaran.namazi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Minoxidil 5% solution, Cetirizine 1% solution and Diclofenac 3% solution in treatment of androgenic alopecia
Public title
Comparison of the Effectiveness of Minoxidil, Cetirizine 1% and Diclofenac 3% in treatment of androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years old men with androgenetic alopecia
No contraindication for topical trreatment
Exclusion criteria:
systemic disease
use of other drug in treatment of androgenic alopecia
other pattern of hair loss
Age
From 18 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
.Sampling and randomization are key elements in studies, especially interventional studies, and rely more on the results of the study, so that based on the standards accepted by journals and editors, one of the elements in the intervention study report clearly and completely. It has to be dealt with, it's a randomization. Random allocation is also one of the goals of bias elimination. One of the randomization methods using the RANDBETWEEN function is in Excel.
This means that each patient is assigned to one of three treatments, respectively
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles are similar in shapes
There is no drug names on the bottles
The physician who takes the photos of patients scalp with fotofinder is blind to study
The physician who evaluate outcomes is blind to study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Shahid Arabi st,Shahid Chamran
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.SBMU.SRC.REC.1398.004
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
severity of hair loss
Timepoint
0,after 2 and 4 months
Method of measurement
fotofinder
Secondary outcomes
empty
Intervention groups
1
Description
Cetirizine 1% solution made by the Shahid Beheshti faculty of pharmacy,1cc twice daily topicaly on the scalp
Category
Treatment - Drugs
2
Description
Diclofenac 3% solution made by the Shahid Beheshti faculty of pharmacy,1cc twice daily topicaly on the scalp
Category
Treatment - Drugs
3
Description
Minoxidil 5% solution made by the Shahid Beheshti faculty of pharmacy,1cc twice daily topicaly on the scalp
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish hospital
Full name of responsible person
Nastaran Namazi
Street address
Shohadaye Tajrish hospital,Tajrish SQ
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
hannane.seifian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of medical sciences
Full name of responsible person
Afshin Zarghi
Street address
Shohadaye Tajrish hospital,Tajrish Sq,
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
hannane.seifian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Namazi Nastaran
Position
Professor Assistant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tajrish sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
+98 21 2271 9014
Email
nastaran.namazi.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Namazi
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Shohadaye tajrish hospital,Tajrish sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nastaran.namazi.md@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Namazi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
dermatology
Street address
Shahrdari St, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
hannane.seifian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD