1) Evaluation of the effectiveness of the ER YAG laser in the treatment of stria alba
2) Comparison of the effectiveness of Nd YAG laser and Erbium YAG laser in the treatment of stria alba
3) Evaluation of the side effects of Nd and Erbium laser treatment
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 20 patients. A simple randomization method was used.
Settings and conduct
20 patients with striae Alba, bilateral
One side of the laser: Nd-YAG and Er: YAG, and the other side of the Er: YAG laser
4 treatment sessions are performed with an interval of one month
Erbium energy, which we will use FSO1, LP, Turbo3, energy 18-21 j/cm2 and pulse duration 200 ms
And for Nd modes, we will use two modes, one is FRAC3 mode and the other is PIANO, which will be as follows:
FRAC3:
Energy 25 j/cm2 and pulse duration 1.6 ms Spot 9 mm
PIANO: Energy 250 j/cm2 and pulse duration 5s Spot 9mm
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with stria alba who have been suffering from the formation of lines for at least 6 months.
Patients aged 18 to 50 years.
Patients' written consent to participate in the study.
Exclusion criteria:
Patients with other active skin diseases.
Pregnancy or lactation.
Not having diabetes or diseases that impair skin healing.
Not being treated with corticosteroids or any medication that impairs skin healing.
Intervention groups
20 patients with striae alba should be treated bilaterally
One side with laser: Nd-YAG and Er:YAG and the other side with Er:YAG laser
4 treatment sessions are performed at an interval of one month
Main outcome variables
Physician satisfaction and patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220924056032N1
Registration date:2025-12-05, 1404/09/14
Registration timing:prospective
Last update:2025-12-05, 1404/09/14
Update count:0
Registration date
2025-12-05, 1404/09/14
Registrant information
Name
safoura shakoei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2655
Email address
dr.shakoei@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-12-06, 1404/09/15
Expected recruitment end date
2027-02-04, 1405/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect of Erbium yag and Nd yag Laser and comparing to the Er:yag on Striae Alba
Public title
Laser treatment for steriae alba
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with striae alba who have been suffering from striae alba for at least 6 months
Patients aged 18 to 50 years
Patients provided written consent to participate in the study.
Exclusion criteria:
Patients with other active skin diseases.
Not be treated with corticosteroids or any medication that interferes with skin healing.
Not have diabetes or diseases that interfere with skin healing.
Pregnancy or breastfeeding.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Twenty patients will be randomly assigned in a single-blinded manner. Patients will be recruited from individuals who visit the laser clinic and meet the inclusion criteria.
The patients will be randomly (block randomization) assigned to the right and left sides of the patients, respectively, to receive the following two treatments:
1) Nd: YAG laser treatment.
2) Erbium YAG and nd yag laser treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
vahdat eslami
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2025-04-28, 1404/02/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.103
Health conditions studied
1
Description of health condition studied
steriae alba
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Improve striae
Timepoint
Before the intervention (first session), third session, and fifth month
Method of measurement
Patient satisfaction between 0-10 and physician satisfaction between 0-100% with visual analogue method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will undergo Erbium and Nd:YAG laser treatment with the Fotona laser device. Up to 4 sessions will be performed once a month.
Category
Treatment - Devices
2
Description
Control group: They will undergo erbium laser treatment with the Fotona laser device, which will be performed once a month for up to 4 sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
safoura shakoei
Street address
Razi hospital, vahdat eslami street, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5561 8989
Email
dr.shakoei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Keshavarz Boulevard, corner of Qods Street, Central University Organization, 6th Floor, Vice President for Research and Technology
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Safoura Shakoei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat eslami street, Tehran
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5561 8989
Email
dr.shakoei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Safoura Shakoei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat eslami street, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5561 8989
Email
dr.shakoei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Safoura Shakoei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat Eslami Street, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5561 8989
Email
dr.shakoei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
It will be made available to researchers upon request from the corresponding author of the study.
When the data will become available and for how long
After published
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Data dissemination is not permitted.
From where data/document is obtainable
Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences (TUMS), Tehran, Iran. Email: dr.shakoei@gmail.com
What processes are involved for a request to access data/document