In this clinical trial study the efficacy of Minoxa shampoo on hair loss is studied. Total of 70 people suffering from hair loss with 15 to 60 years of age selected and randomly divided into two intervention and control groups via block method. Inclusion criteria consisted of age 15 to 60 years and no treatment for hair loss in the past six months. Exclusion criteria included pregnancy, lactation, underlying diseases that cause hair loss (diabetes, hypertension and thyroid disease), using rugs that cause hair loss in previous month, and scarring alopecia. Both groups will receive standard treatment. In the intervention group Minoxa shampoo and in the control group placebo shampoo is used every other day for 3 months. Patients do not know in which group they are located (single blind). Patients are followed monthly by a dermatologist in terms of drug and shampoo use and complications including: erythema, desquamation, dry skin, burning or itching. The process of hair loss treatment and recovery rates for the two groups on a monthly basis goes on by dermatologists and recorded in hair-assessment checklist.
General information
Acronym
Minoxa
IRCT registration information
IRCT registration number:IRCT2013031112563N3
Registration date:2014-09-29, 1393/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
FARDIN GHARIBI
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3187 2281
Email address
fardin.gharibi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial study on the effect of Minoxa shampoo in Alopecia Areata
Public title
Minoxa shampoo effect in Alopecia Areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consisted of age 15 to 60 years, no treatment for hair loss in the past six months.
Exclusion criteria included pregnancy, lactation, underlying diseases that cause hair loss (diabetes, hypertension, thyroid disease), using rugs that cause hair loss in previous month, and scarring alopecia.
Age
From 15 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St, Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
6618634683
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
14/47256
Health conditions studied
1
Description of health condition studied
Alopecia
ICD-10 code
L63.0
ICD-10 code description
Alopecia (capitis) totalis
Primary outcomes
1
Description
Alopecia treatment
Timepoint
Before the intervention, one month, two months and three months after the intervention.
Method of measurement
Counting the number of hairs in Alopecia
Secondary outcomes
1
Description
Itching, redness, scaling
Timepoint
One month, two months and three months after the intervention.
Method of measurement
Clinical Examination
Intervention groups
1
Description
In the control group placebo is used every other day for 3 months .
Category
Treatment - Drugs
2
Description
In the intervention group Minoxa shampoo is used every other day for 3 months .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Office
Full name of responsible person
Roxsana Yaghmaee
Street address
Pasdaran Ave, Medical Complex
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Full name of responsible person
Mozhdeh Zarei
Street address
Pasadaran St, Kurdistan University of Medical Sciences
City
Sanadaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Position
MAs
Other areas of specialty/work
Street address
Pasdaran St, Kurdistan University of Medical Sciences