Comparison of the efficacy of microneedle radiofrequency combined with subcision vs microneedle radiofrequency alone in treatment of depressed acne scar
Patients received microneedle radiofrequency on both sides of their faces during three sessions. There was a 4-week interval between each two sessions.
Objectives: To compare the efficacy of microneedle radiofrequency in combination with subcision and microneedle radiofrequency alone in the treatment of depressed acne scars. Design: Randomized, single blind, clinical trial. Setting and Conduct: In this study, 25 patients were selected for acne scar treatment and primary data were collected and then eligible patients received subcision on one side of the face chosen randomly (Using random numbers table). After 2 weeks, Patients received microneedle radiofrequency on both sides of their faces during three sessions. There was a 4-week interval between each two sessions.
Outcome measures were assessed by two dermatologists blinded to the randomization through serial photography at baseline and 3 months after the last therapy session. Inclusion criteria: Age ≥ 18 years; patient suffering from polymorphic and mixed acne scars; presence of acne scars on both sides of the face; Fitzpatrick skin types 2 to 4; informed consent for participation. Exclusion Criteria: presence of hypertrophic or Keloid scars.
Conduct and interventions: Intervention group: in one side of the face, subcision was done and after 2 weeks, the process of treatment was followed by three sessions of microneedle radiofrequency. There was a 4-week interval between each two sessions.
Control group: the other side of the face received microneedle radiofrequency without subcision during three sessions. There was a 4-week interval between each two sessions.
Main Outcome Measures: Improvement of acne scar assessed by two dermatologists blinded to the randomization process (through serial photography).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103130597N1
Registration date:2017-01-26, 1395/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-26, 1395/11/07
Registrant information
Name
Nazila Poostiyan
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 0079
Email address
n.poostiyan@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of microneedle radiofrequency combined with subcision vs microneedle radiofrequency alone in treatment of depressed acne scar
Public title
Efficacy of microneedle radiofrequency with or without subcision for treatment of depressed acne scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age ≥ 18 year; patient suffering from polymorphic and mixed acne; the acne scars should be in both sides of the face; Fitzpatrick skin types 2 to 4; informed consent for participation in the study. Exclusion Criteria: patients who are suffering from hypertrophic or Keloid scars.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization was done based on random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of 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
2016-07-25, 1395/05/04
Ethics committee reference number
IR.MUI.REC.1395.3.325
Health conditions studied
1
Description of health condition studied
acne scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Atrophic scar of acne
Timepoint
Baseline,three months after the last therapy session
Method of measurement
Serial photography and evaluation by two dermatologists blinded to the randomization process
Secondary outcomes
1
Description
Edema; Erythema; Pruritis; Hypo and Hyper pigmentation
Timepoint
After two weeks of each therapy session
Method of measurement
Patient self administered checklist of overall satisfaction
2
Description
Clinical improvement of atrophic scar
Timepoint
Baseline,three months after the last therapy session
Method of measurement
Serial photography and evaluation by two dermatologists blinded to the randomization process
3
Description
Patients satisfaction
Timepoint
Three months after the last therapy session
Method of measurement
Patient self administered checklist of overall satisfaction
Intervention groups
1
Description
Intervention group: in one side of the face, subcision was done and after 2 weeks, the process of treatment was followed by three sessions of microneedle radiofrequency. There was a 4-week interval between each two sessions.
Category
Treatment - Devices
2
Description
Control group: the other side of the face received microneedle radiofrequency without subcision during three sessions. There was a 4-week interval between each two sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra general hospital
Full name of responsible person
Dr Nazila Poostiyan
Street address
Department of Dermatology, Al-Zahra Hospital,Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Skin disease and Leishmaniasis Research Center
Full name of responsible person
Dr Nazila Poostiyan
Street address
Skin disease and Leishmaniasis Research Center, KHorram street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Nematbakhsh
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
Vice Chancellor for research of 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 disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences,
Full name of responsible person
Dr Nazila Poostiyan
Position
Assistant of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
n.poostiyan@resident.mui.ac.ir
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, Ira
Full name of responsible person
Dr Gita Fagihi
Position
professor
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 3668 5555
Fax
Email
g_fagihi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr Nazila Poostiyan
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 3668 5555
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)