This project is a random double blind clinical trial study due to be carried out in clinics and educational establishments supervised by Isfahan University of Medical Sciences during 1393 H. The subjects are sixteen patients afflicted by dominant rolling and boxcar scars who have not been laser-treated for twelve, or recieved isotretinoin for six months. The division of their faces will be twofold (right and left parts) and the subjects randomly put into two groups of sixteen each. The first group is to be treated with Prp and fractional co2 laser; the second with only fractional co2 laser. In the latter group normal saline will be injected in place of PRP to avoid any awareness of the procedure in the patients. This treatment will be effected twice with a one month interval in between. The patients will be required to take photographs serially before and one month after the first treatment session and four months after the second. The photographs will be scored by two dermatologists using the quartile scale. Evaluation of adverse effects (erythem an edema) is by the patients and based on the self– assessment at days 0,2,4,6,8,15, 30 after each treatment session – and the visual analogue scale for scoring. Patient satisfaction will also be scored by quartile scale. Data analysis is with SPSS software.
General information
Acronym
PRP:Platelet Rich Plasma
IRCT registration information
IRCT registration number:IRCT2014080218648N1
Registration date:2014-10-11, 1393/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-11, 1393/07/19
Registrant information
Name
Shima Keyvan
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 2119
Email address
sh.kayvan@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Isfahan University of Medical Sciences.
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Autologous Platelet Rich Plasma Combined with Ablative Carbon Dioxide Fractional Resurfacing laser vs Ablative Carbon Dioxide Fractional Resurfacing laser alone in Acne scar treatment
Public title
Efficacy of Platelet Rich Plasma and fractional co2 laser in treatment of acne scar of face
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.Patients who have polymorphic and mixed acne scar (dominantly rolling and boxcar types ,less than ٪20 ice pick type and no hypertrophic or keloid type) 2.Patients who dont have other skin disease 3.Patients who have skin types 3-5 in fitzpatrick scale 4. Willingness for participation in the study and signing the consent form.
Exclusion criteria:1.Known allergic reaction to components of study treatment that leads to unfinished study 2.Patient is unwilling to continue the study 3.Co-treatment with other methods 4.History of keloid formation 5.Any kind of active inflammation 6. Oral isotretinoin use within the preceding 6 months 7. Diabetes, collagen vascular disease 8. Ablative or nonablative laser skin resurfacing within the preceding 12 months, 9.Pregnancy or lactation 10.If patient doesnt follow the study .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Postal code
Approval date
2014-01-08, 1392/10/18
Ethics committee reference number
393020
Health conditions studied
1
Description of health condition studied
acne scar
ICD-10 code
L90.5
ICD-10 code description
scar cndition and fibrosis of skin
Primary outcomes
1
Description
Atrophic scar of acne
Timepoint
Before and after the intervention
Method of measurement
Photography of scar before beginning ,1 month after first session of treatment and 4 months after second session of treatment
Secondary outcomes
1
Description
Clinical improvement of scar
Timepoint
1 month after first session of treatment and 4 months after second session of treatment
Method of measurement
Self-assessment by the patients and visual analogue scale
2
Description
treatment associated adverse events(erythema and edema)
Timepoint
days 0, 2, 4, 6, 8, 15, and 30 after each session of treatment
Method of measurement
serial photography,inspection by dermatologist and visual analogue scale
3
Description
Patients satisfaction
Timepoint
1 month after first session of treatment and 4 months after second session of treatment
Method of measurement
Quartile scale
Intervention groups
1
Description
20cc patient blood will be taken and mixed with anticoagulant in a ratio of 1:10 (anticoagulant/blood). The mixture will then be centrifuged at a speed of 2,000 rpm for 3 minutes and the residue will be centrifuged again with concentration kit for 5 minutes at 5,000 rpm. 4cc PRP will finally be obtained. The PRP is to be obtained using a commercially available two-part system (Prosys PRP, T•Cell Bio Inc., Seoul, South Korea ) and mycells kit produced by South Korea. One side of the face (scar site) will receive 0.2mL of PRP at 2cm interval immediately after laser treatment. Participants will then be instructed to compress their faces with gauze for 15 to 20 minutes. Control group: The other side of the face(scar site), will receive 0.2mL of normal saline at 2cm interval on the scar site immediately after laser treatment. Participants will be instructed to compress their faces with gauze for 15 to 20 minutes.
Category
Other
2
Description
Intervention group:The intended procedure is to be a pass of ablative fractional co2 laser – a setting of laser power: 25, dot cycle (duration): 3, energy: 30 mj, pixel pitch: 1, and ablation depth: 600 µm -on one side of the face. Control group: The intended procedure is to be, in similar fashion to the intervention group, a pass of ablative fractional co2 laser – a setting of laser power: 25, dot cycle (duration): 3, energy: 30 mj, pixel pitch: 1, and ablation depth: 600 µm- on the other side of the face
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Zahra hospital
Full name of responsible person
Dr Shima Keyvan
Street address
Department of Dermatology, Al-Zahra hospital, Soffeh Blvd, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ebrahim Esfandiari
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Dr shima keyvan
Position
Assistant of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences . Isfahan
City
Isfahan
Postal code
Phone
+98 31 3664 2119
Fax
Email
sh.kayvan7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Disease and Leishmaniasis Research Center Isfahan University of Medical Sciences . Isfahan Is
Full name of responsible person
Dr Gita Faghihi
Position
Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences . Isfahan
City
Isfahan
Postal code
Phone
+98 31 3663 3061
Fax
Email
g_faghihi@med.mui.ac.ir
Web page address
www.med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Shima Keyvan
Position
Assistant of dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3664 2119
Fax
Email
sh.kayvan7@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)