Objectives: To assess the effect of CO2 fractional laser versus microneedling on treatment of patients with atrophic acne scars
Design: A single blind randomized clinical trial.
Setting and conduct: The eligible patients with atrophic acne scars who will refer to Sina Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; atrophic acne.
Exclusion criteria: Pregnancy or breastfeeding; Dermal disease or infection like impetigo; herpes simplex; flat wart; severe skin disease; susceptibility to keloid; acne rosacea; Active acne; using isotretinoin in the past 6 months; photosensitivity; psychological disorders.
Intervention group 1: Treatment of skin lesion with CO2 fractional laser 4 times with 3 weeks interval.
Intervention group 2: Treatment of skin lesion with microneedling 4 times with 3 weeks interval.
Primary outcome: Measuring skin lesions with photography before, and 1, 2, and 6 month after intervention.
Randomization: Each patient will be his/her own control, so that, the skin lesions on one side will be treated with one approach and the other side with another approach. The left and right side of the body will assigned randomly to each treatment by tossing coin.
Blinding: Patients will be unaware of the type of treatment. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701319014N142
Registration date:2017-02-13, 1395/11/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of CO2 fractional laser versus microneedling on treatment of patients with atrophic acne scars: a single blind randomized clinical trial
Public title
Effect of CO2 fractional laser versus microneedling on treatment of patients with atrophic acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; atrophic acne.
Exclusion criteria: Pregnancy or breastfeeding; Dermal disease or infection like impetigo; herpes simplex; flat wart; severe skin disease; susceptibility to keloid; acne rosacea; Active acne; using isotretinoin in the past 6 months; photosensitivity; psychological disorders.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Each patient will be his/her own control, so that, the skin lesions on one side will be treated with one approach and the other side with another approach. The left and right side of the body will assigned randomly to each treatment by tossing coin.
Blinding: Patients will be unaware of the type of treatment. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.474
Health conditions studied
1
Description of health condition studied
Atrophic acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Measuring skin lesions
Timepoint
before, and 1, 2, and 6 month after intervention
Method of measurement
with photography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treatment of skin lesion with CO2 fractional laser 4 times with 3 weeks interval.
Category
Treatment - Drugs
2
Description
Intervention group 2: Treatment of skin lesion with microneedling 4 times with 3 weeks interval.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Sina Khanali
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Sina Hospital
Full name of responsible person
Dr Sina Khanali
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
sina.khanali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr Pedram Alirezaei
Position
Dermatologist
Other areas of specialty/work
Street address
Sina Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
prc@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)