This is a pilot study. Patients referred to clinics of Skin and Stem cell Research Center and also Jordan and Novin laser clinic in 2013-2014 will be enrolled in this study. Inclusion Criteria: Age 30-50 - Patients with mild to moderate wrinkles according to Glogue scale I-III – No coagulation disorders and use of anti coagulated drugs - No infection in treated site - No fever able diseases – No chronic liver diseases - No pregnancy or breast-feeding. After filling the questionnaire and consent form (with explanation of study benefits) and after taking the photography, patients will be randomly (according to Saghai randomization software) divided in to 15 person groups: First group will be treated with platelet rich plasma (PRP) along with Co2 fractional laser and second group will be treated with Co2 fractional laser alone. Photography will be taken from patients 1 and 3 months after treatment and the information of patients will be recorded. Then the pictures will be assessed by 2 blinded physicians and will be ranked according to improvement percents and scores: Improvement of 0-25%: Score 1, Improvement of 26-50%: Score 2, Improvement of 51-75%: Score 3, Improvement more than 75%: Score 4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308281159N10
Registration date:2013-09-22, 1392/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
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
2012-12-21, 1391/10/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of platelet rich plasma with fractional Co2 laser and fractional Co2 laser alone on skin rejuvenation in patients with aging
Public title
Comparison of platelet rich plasma and fractional Co2 laser on skin rejuvenation in patients with aging
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age 30-50 - Patients with mild to moderate wrinkles according to Glogue scale I-III – No coagulation disorders and use of anti coagulated drugs - No infection in treated site - No fever able diseases – No chronic liver diseases - No pregnancy or breast-feeding.
Exclusion Criteria: Patients who will not return for follow up visits or are not willing to participate will be excluded.
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done using random number table. Also because the pictures will be assessed by 2 blinded physicians, so this study is single blinded.
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
2012-12-01, 1391/09/11
Ethics committee reference number
70441
Health conditions studied
1
Description of health condition studied
Face wrinkles
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of skin and subcutaneous tissue
Primary outcomes
1
Description
Severity of face wrinkles
Timepoint
Before treatment and 1 and 3 months after treatment
Method of measurement
Glogue wrinkle scale
Secondary outcomes
empty
Intervention groups
1
Description
Treatment of platelet rich plasma (PRP) + fractional Co2 laser: First, patients will be anesthetized with topical Lidocaine-P and then will be treated with Co2 fractional laser (Dosis) with pixel pitch: 1, dot cycle: 3 and power:15 for 4 sessions with 3 week intervals and superficial injection of platelet rich plasma (prepared by Zist Partak laboratory) 1 week after last laser session that small bump will be appeared. Many superficial injections will be nearly done with 1 cm intervals.
Category
Treatment - Other
2
Description
Treatment with fractional Co2 laser alone: Patients will be anesthetized with topical Lidocaine-P and then will be treated with Co2 fractional laser (Dosis) with pixel pitch: 1, dot cycle: 3 and power: 15 for 4 sessions with 3 week intervals.
Category
Treatment - 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
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 and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohamad Ali Nilforoushzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Skin and Stem Cell Research Center, third floor, no 4, Maryam impasse, Kamranieh st, Tehran
City
Tehran
Postal code
Phone
+98 21 2221 2537
Fax
Email
sdlrc@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)