Comparison of micro needle radio-frequency plus fractional co2 laser efficacy versus micro needle radio frequency device alone in treatment of stria alba
stria alba are atrophic linear scars caused by skin tension during pregnancy or rapid weight gain.stria may cause disturbing cosmetic problems and in spite of all the different modalities that have been used in treatment of this condition there's no gold standard method of treatment introduced till present. micro needle radio-frequency devices have been used in treatment of various atrophic scars including stria alba and have shown promising results in treatment of this condition.this study is aimed to evaluate the efficacy of micro needle radio-frequency combined with co2 fractional laser in treatment of stira alba. A randomized, clinical trial was done on 6 young adults (27-40 Years) with clinically diagnosed stria alba (total stria count 96) .The inclusion criteria were Age between 27 and 40 years old, stria alba on the abdomen, buttocks, thighs, knees, calves and flanks and skin photo-type III and exclusion criteria were pregnancy, breastfeeding, stria alba on the chest or shoulders or arms, positive history of treatment with systemic or topical corticosteroids and patients with cushing or ehlers-danlos syndrome.The patients stria were divided into two groups using table of randomization.(Side A: treated by micro needle Radio-frequency combined with fractional co2 laser and Side B: Treated only by micro needle Radio-frequency device.) Side A stria were treated with 1 session of fractional co2 laser followed by 3 sessions of micro needle radio-frequency laser and again 1 last session of co2 fractional laser. in contrast Side B stria were treated with 3 sessions of micro needle radio-frequency laser alone.each treatment sessions were 2 weeks apart.all the lesions were photographed before treatment and1 month after treatment completion and changes in surface area of stria were analyzed with pictzar software.also all pictures were evaluate by two unrelated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101519543N1
Registration date:2014-11-28, 1393/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Shadi Behfar
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3666 1399
Email address
shadi_behfar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-01-10, 1392/10/20
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of micro needle radio-frequency plus fractional co2 laser efficacy versus micro needle radio frequency device alone in treatment of stria alba
Public title
Treatment of stria alba by micro needle radio-frequency device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:stria alba on the abdomen, buttocks, thighs, knees, calves and flanks; skin photo-type III; negative history of previous stria treatment Exclusion criteria: pregnancy; breastfeeding; history of previous stria treatment; stria alba on the chest or shoulders or arms; positive history of treatment with systemic or topical corticosteroids; patients with cushing or ehlers-danlos syndrome; positive history of treatment with oral isotretinoin or filler injection over last year; history of dermabrasion or laser skin resurfacing therapy over last year;
Age
From 27 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Postal code
Approval date
2014-01-07, 1392/10/17
Ethics committee reference number
393433
Health conditions studied
1
Description of health condition studied
striae alba
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Stria alba lesions
Timepoint
Base line, weeks 12, weeks 20
Method of measurement
Total Surface Area of stria alba and Visual Analogue Scale
Secondary outcomes
1
Description
Side effects Of Laser treatments
Timepoint
every 2 weeks
Method of measurement
Visual clinical evaluation
Intervention groups
1
Description
Side A stria were treated with 1 session of fractional co2 laser and followed by 3 sessions of micro needle radio-frequency treatment and 1 last session of fractional co2 laser.each laser treatment session was 2 weeks apart from each other.before each session lidocain cream were used on treatment area for about 60 min to achieve proper anesthesia.after each treatment the mupirocin and zinc oxide ointment were applied on the area and Vaseline gauze were used to dressing the treated area.total treatment period was 8 weeks and evaluation were done on baseline and 12 weeks of treatment. Follow up period was 3 months.
Category
Treatment - Devices
2
Description
Side B stria were treated with 3 sessions of micro needle radio-frequency treatment. each laser treatment session was 2 weeks apart from each other.before each session lidocain cream were used on treatment area for about 60 min to achieve proper anesthesia.after each treatment the mupirocin and zinc oxide ointment were applied on the area and Vaseline gauze were used to dressing the treated area.total treatment period was 4 weeks and evaluation were done on baseline and 8 weeks of treatment. Follow up period was 3 months.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Novin laser Centre
Full name of responsible person
Street address
sheikh sadugh Ave.
City
Isfahan
2
Recruitment center
Name of recruitment center
skin and leishmania research centre
Full name of responsible person
Street address
khorram Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Esfandiari, Vice Chancellor for research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
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, 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Shadi Behfar
Position
Resident of Dermatology/MD.
Other areas of specialty/work
Street address
Dermatology Group, Alzahra Hospital, Soffeh Blvd.
City
Isfahan
Postal code
Phone
+98 31 3666 1399
Fax
Email
shadi_behfar@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Farahnaz Fatemi Naeini
Position
Professor of Dermatology
Other areas of specialty/work
Street address
Dermatology Group, Alzahra Hospital, Soffeh Blvd.
City
Isfahan
Postal code
Phone
+98 31 3792 2435
Fax
Email
fatemi_farahnaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Shadi Behfar
Position
Resident of Dermatology/MD.
Other areas of specialty/work
Street address
Dermatology Group, Alzahra Hospital, Soffeh Blvd.
City
Isfahan
Postal code
Phone
+98 31 3666 1399
Fax
Email
shadi_behfar@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)