This is a pilot study that will be performed on adult patients with alopecia areata (ophiasis type) referred to Skin Diseases and Leishmaniasis Research Center and clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences. Inclusion Criteria: Adult patients above 15 years old that do not willing to inject corticosteroid. Ten patients that are eligible will be taken consent form. First, patients will be used ice pack for 10 minutes to anesthetize the treatment site. A half of treatment site in any patient will be used 0.05% clobetasole lotion 2 times a day until complete improvement or 12 weeks and another half will be treated with fractional CO2 laser (Dosis company) with power: 15, Pixel pitch: 1, Dot cycle: 3 and 1 pass every 2 weeks for 4-6 times and then use of the topical clobetasole lotion 2 times a day until complete improvement or 12 weeks. Patients will be followed up every month and hair re-growth rate will be assessed by Point semiquantitative scoring (RGS-5) and trichoscan device according follow: 0- hair re-growth less than 10% 1- hair re-growth 11-25% 2-hair re-growth 26-50% 3- hair re-growth 51-75% 4-hair re-growth more than 75%. Also photography will be taken before and every 2 weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309041159N11
Registration date:2013-10-20, 1392/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-20, 1392/07/28
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-08-18, 1391/05/28
Expected recruitment end date
2013-12-19, 1392/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of fractional CO2 laser and topical clobetasole versus topical clobetasole in treatment of patients with alopecia areata
Public title
Comparative efficacy of fractional laser and clobetasole in Alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:1- Severity of alopecia less than of head 2- No sensitivity to corticosteroid 3- No bacterial infection on treatment site 4- No pregnancy or breast-feeding 5- Adult patients above 15 years old that do not willing to inject corticosteroid.
Exclusion Criteria: Patients who will not return for follow up visits or are not willing to participate will be excluded.
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-08-18, 1391/05/28
Ethics committee reference number
62847
Health conditions studied
1
Description of health condition studied
Alopecia areata (ophiasis)
ICD-10 code
L63.2
ICD-10 code description
Ophiasis alopecia areata
Primary outcomes
1
Description
Hair re-growth rate
Timepoint
Before intervention and every month after intervention until 3 months
Method of measurement
Point semiquantitative scoring (RGS-5) and Trichoscan device
Secondary outcomes
empty
Intervention groups
1
Description
A half of treatment site will be used 0.05% clobetasole lotion (Darou pakhsh company) 2 times a day until complete improvement or 12 weeks
Category
Treatment - Drugs
2
Description
Another half of treatment site will be treated with fractional co2 laser (Dosis company) with power: 15, Pixel pitch: 1, Dot cycle: 3 and 1 pass, every 2 weeks for 4-6 times and then use of topical 0.05% clobetasole lotion (Darou pakhsh company) 2 times a day until complete improvement or 12 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Elaheh Haftbaradaran
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
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, Tehran 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
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Full name of responsible person
Elaheh Haftbaradaran
Position
General Physician
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
elahe_MD2003@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Full name of responsible person
Fariba Jaffary
Position
Associate professor
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
jaffary@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)