Striae are visible linear scars caused by streching of skin in areas of dermal injury. Different lasers are used in the treatment of striae. This was a Double blinded comparative study of right and left on 88 striae in patients with striae alba. Sampling was done randomly. Striae were divided into 2 groups on the left and right. On one side, 5 sessions fractional carbon dioxide with pulsed dye laser every 2 weeks were done (3 sessions fractional carbon dioxide and 2 sessions of pulsed dye laser) and on the other side just 3 sessions of fractional carbon dioxide every 4 weeks. fractional CO2 laser: 10600 nm, Flu: 16±2 J/cm2 Pulsede dye laser: 585nm, Flu: 5-7 J/cm2. All striae alba lesions in patients before treatment and two weeks after the end, were photographed. Photographs before and after treatment were analyzed by the application of Pict Zar, and lesion area was calculated. The photos in this scheme were reviewed and scored by two dermatologists, non-therapist and unaware of used treatment. At the end of the treatment period, patients' satisfaction rate for both methods was evaluated with the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013123116013N1
Registration date:2014-02-10, 1392/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-10, 1392/11/21
Registrant information
Name
Zahra Nikyar
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 1621
Email address
z.nikyar@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-11-20, 1391/08/30
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion the Fractional Co2 laser and Pulsed Dye laser with Fractional Co2 laser alone in treatment of striae alba
Public title
Treatment of striae alba with Pulsed dye laser and Fractional Co2 laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: striae alba found on the abdomen, hips, thighs and flanks; have not received any previous treatment for striae ; skin types 3 and 4 Exclusion criteria: pregnancy; lactation; stria alba on the chest and arms; previous treatment with medication or laser for striae; history of local or systemic steroid use; Cushing's syndrome or Ehlers-Danlos syndrome; use of isotretinoin or filler injections in 6 to 12 months Furthermore; performance of dermabrassion or laser skin rejuvenation in previous 6 to 12 months on striae
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Double- blined comparative right and left
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Deputy of research of Isfahan University of Medical Science, hezarjerib street, Isfahan
City
Isfahan
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
392210
Health conditions studied
1
Description of health condition studied
striae
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Striae Area
Timepoint
Baseline and two weeks after the end of laser therapy
Method of measurement
Pictzar software
2
Description
Striae Area
Timepoint
Baseline and after intervention
Method of measurement
4- points scale by dermatologists who were not therapist
Secondary outcomes
1
Description
severe erythema
Timepoint
After each session and every month
Method of measurement
clinical examination
2
Description
hyperpigmentasion
Timepoint
after each session and every month
Method of measurement
clinical examination
3
Description
Edema
Timepoint
After each session and every month
Method of measurement
Clinical Examination
4
Description
Patient assessment
Timepoint
End of study
Method of measurement
Visual Analogue Scale(VAS)
Intervention groups
1
Description
On one hand can be treated with Fractional CO2 laser and Pulsed dye lasers in the intermittent sessions. A total of 5 sessions every two weeks (3 sessions Fractional carbon dioxide laser and 2 sessions of pulsed dye laser). Fractional CO2 laser; 10600 nm; 16±2 J/cm2 Pulsede dye laser: 585nm; Flu: 5-7 J/cm2; Spot size:7mm
Category
Treatment - Other
2
Description
On the other hand was treated with 3 sessions with fractional carbon dioxide laser every four weeks. Fractional CO2 laser; 10600 nm; 16±2 J/cm2
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital dermatology clinic
Full name of responsible person
Dr. Zahra Nikyar
Street address
Departmen of Dermatology;Al-Zahra hospital, Soffeh Avenue
City
Isfahan
2
Recruitment center
Name of recruitment center
Noor and Aliasghar Hospitals dermatology clinics
Full name of responsible person
Dr. Zahra Nikyar
Street address
Ostandari street
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 Science, hezarjerib street, 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 and Leishmaniasis Research Center- Isfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Nikyar
Position
Resident of dermatology/MD
Other areas of specialty/work
Street address
Dermatology group-Alzahra hospital-Esfahan
City
Isfahan
Postal code
Phone
+98 31 1268 3597
Fax
Email
Z.nikyar@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Leishmaniasis Research Center-Isfahan University of Medical Sciences
Full name of responsible person
Dr. Farahnaz Fatemi naeini
Position
Assosiate Professor of dermatology
Other areas of specialty/work
Street address
Dermatology group-Alzahra hospital-Esfahan
City
Isfahan
Postal code
Phone
+98 31 1777 2134
Fax
Email
fatemi_farahnaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Nikyar
Position
Resident of dermatology
Other areas of specialty/work
Street address
Dermatology group-Al-zahra hospital-Isfahan
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)