The aim of this study is comparing the effIcacy of co2 laser versus co2 laser and PRP in patients with POH.100 women patients are randomaly devided into 2 groups.
in the first group only co2 laser will be done,in the other group,firstly co2 laser will be done,and immediately after that PRP applied.
3 sessions of treatment with 1 month interval in each group are going to be done.
these mentioned 2 groups will be followed for 3 and 6 months.
on each following,photos will be taken and compared with previous photos,to evaluate the effect of treatment in POH.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103118210N4
Registration date:2015-11-29, 1394/09/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-23, 1395/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of co2 laser versus co2 laser and PRP on periorbital hyperpigmentation
Public title
Comparison of the effect of co2 laser versus co2 laser and PRP on periorbital hyperpigmentation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:presence of POH;20-50 years old;women
exclusion criteria:patients with platelet function impairment;severe thrombocytopenia(less than 50000);hemodynamic unstability;chronic hematologic disease(diabetes;chronic infection and blood dyscrasia);local inflammatory skin disorder or active herpes infection in site of procedure;consuming anticoagulant drugs or NSAIDs 48 hours before procedure;consuming topical corticosteroids in site of treatment 1 month before procedure;consuming systemic corticosteroids 2 weeks before procedure;fever;cancer(specially bone marrow or hematologic);level of hemoglubin lower than 10 gr in dl.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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
ethic committee of Iran University of Medical Scienses
Street address
Iran University-hemmat highway
City
Tehran
Postal code
19922347512
Approval date
2015-09-26, 1394/07/04
Ethics committee reference number
IR.IUMS.REC.1394.26228
Health conditions studied
1
Description of health condition studied
periorbital hyperpigmentation
ICD-10 code
L81.9
ICD-10 code description
Disorder of pigmentation, unspecified
Primary outcomes
1
Description
periorbital hyperpigmentation
Timepoint
3 monyhs and 6 months later
Method of measurement
photography
Secondary outcomes
1
Description
lightening the periorbital skin
Timepoint
3 months and 6 months later
Method of measurement
photography
Intervention groups
1
Description
co2 laser:is an ablative form of laser which affects superficial layer of the skin tissue
Category
Treatment - Devices
2
Description
PRP:platelet rich plasma is uptaken from their blood after centrifuge
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool hospital
Full name of responsible person
Dr Elham Behrangi
Street address
Sattarkhan st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of Iran University of Medical Sciences research committee
Full name of responsible person
Dr.Morteza Nasserbakht
Street address
Iran University-hemmat highway
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 of Iran University of Medical Sciences research committee
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
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
professor
Other areas of specialty/work
Street address
dermatology department,Rasool hospital,Sattarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6698
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address
www.IUMS.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Unversity of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
professor
Other areas of specialty/work
Street address
dermatology department,Rasool hospital,Sattarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address
www.IUMS.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
professor
Other areas of specialty/work
Street address
dermatology department,Rasool hospital,Sattarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address
www.IUMS.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)