Comparisons between fractional laser, microneedeling and combination therapy of microneedeling and topical platelet-rich plasma (PRP) in atrophic acne scars treatment
The aim of this study is to determine the effectiveness of microneedeling for treatment of atrophic acne scars as a new method of treatment. The study is a single blind randomized clinical trial (RCT) that will be performed on 3 groups of 30 patients. Inclusion criteria : Atrophic acne scars; Ages 20 to 50 years old. Exclusion criteria: Active acne; Patients with platelet dysfunction, severe thrombocytopenia; Hemodynamic instability or chronic blood disorder; Inflammatory skin disorder, local or herpes infection active in the procedure site; Taking an anticoagulant or NSAID within 48 hours ago.
The first group will be treated by 4 times Fractional CO2 laser 3 weeks apart and the second group will be treated by 4 times microneedeling 3 weeks apart and the third group will be treated by 4 times microneedeling and topical PRP 3 weeks apart.
We will evaluate all of the patients for qualitative and quantitative heeling assessments of scars with visioface device on admission and at each treatment session and 3 months after the last session. In addition, changes in the amount and intensity of scars based on Goodman and Baron qualitative scar grading system will be evaluated a blinded specialist. At each visit, patient will be asked about the healing of acne scars based on the Visual analog scale (VAS, 0-10 point scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110318210N6
Registration date:2015-11-14, 1394/08/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-14, 1394/08/23
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
2015-10-22, 1394/07/30
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisons between fractional laser, microneedeling and combination therapy of microneedeling and topical platelet-rich plasma (PRP) in atrophic acne scars treatment
Public title
The efficacy of microneedeling in treatment of acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient with atrophic acne scars; Ages 20 to 50 years old
Exclusion criteria: Active acne; Patients with platelet dysfunction, sever thrombocytopenia (less than 50,000); Any hemodynamic instability or chronic diseases (such as diabetes, chronic infections, blood dyscrasia ); Local inflammatory skin disorder or active herpes infection at the site of the procedure; Taking an anticoagulant or NSAID within 48 hours before the procedure; Corticosteroid injection at the treatment site during 1 month; Use of systemic corticosteroids within 2 weeks; Fever or recent illness; Cancer, particularly bone or blood; Hemoglobin level less than 10 grams per deciliter
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway
City
Tehran
Postal code
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.IUMS.REC.1394.26556
Health conditions studied
1
Description of health condition studied
acne
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
2
Description of health condition studied
Atrophic scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Response to treatment
Timepoint
Three weeks after each session and 3 months after the last session
Method of measurement
By a physician, according to the measure of the severity of acne scar goodman and high quality photography by visioface device
2
Description
Patient satisfaction rate of response to treatment
Timepoint
Three weeks after each session and 3 months after the last session