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General information
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Due to the lack of long pulse mode on the Nd:YAG device available at the laser center, another mode of the same wavelength, the Q-switch form, has been used.
Due to the lack of long pulse mode on the Nd:YAG device available at the laser center, another mode of the same wavelength, the Q-switch form, has been used.
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با توجه به موجود نبودن long pulse mode روی دستگاه Nd:YAG موجود در مرکز لیزر از mode دیگر همین طول موج یعنی فرم Q switch استفاده شده است.
با توجه به موجود نبودن long pulse mode روی دستگاه Nd:YAG موجود در مرکز لیزر از mode دیگر همین طول موج یعنی فرم Q switch استفاده شده است.
Comparison of the efficacy and safety of PDL, IPL and long pulse Nd:Yag 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris
Comparison of the efficacy and safety of PDL, IPL and Q switch Nd:YAG 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris
Comparison of the efficacy and safety of PDL, IPL and long pulseQ switch Nd:YagYAG 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris
ﻣﻘﺎﯾﺴﻪ اﺛﺮﺑﺨﺸﯽ و اﯾﻤﻨﯽ ﻟﯿﺰر ﻫﺎي PDL ، IPL و Nd: YAG1064 long pulse در درﻣﺎن آﮐﻨﻪ اﻟﺘﻬﺎﺑﯽ ﺧﻔﯿﻒ ﺗﺎ ﻣﺘﻮﺳﻂ ﺻﻮرت
ﻣﻘﺎﯾﺴﻪ اﺛﺮﺑﺨﺸﯽ و اﯾﻤﻨﯽ ﻟﯿﺰر ﻫﺎي PDL ، IPL و Nd: YAG1064 Q switch در درﻣﺎن آﮐﻨﻪ اﻟﺘﻬﺎﺑﯽ ﺧﻔﯿﻒ ﺗﺎ ﻣﺘﻮﺳﻂ ﺻﻮرت
ﻣﻘﺎﯾﺴﻪ اﺛﺮﺑﺨﺸﯽ و اﯾﻤﻨﯽ ﻟﯿﺰر ﻫﺎي PDL ، IPL و Nd: YAG1064 long pulseQ switch در درﻣﺎن آﮐﻨﻪ اﻟﺘﻬﺎﺑﯽ ﺧﻔﯿﻒ ﺗﺎ ﻣﺘﻮﺳﻂ ﺻﻮرت
Recruitment centers
#1
Name of recruitment center - English: Rasoul akram hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Mohammadreza Ghassemi
Full name of responsible person - Persian: محمدرضا قاسمی
Street address - English: Rasoul akram hospital, Mansouri street, Sattarkhan Ave
Street address - Persian: خیابان ستارخان، خیابان مازیار منصوری، بیمارستان رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2390
Fax:
Email: Keramatihaniyeh73@gmail.com
Web page address:
Name of recruitment center - English: Rasoul akram hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Mohammadreza Ghassemi
Full name of responsible person - Persian: محمدرضا قاسمی
Street address - English: Rasoul akram hospital, Mansouri street, Sattarkhan Ave
Street address - Persian: خیابان ستارخان، خیابان مازیار منصوری، بیمارستان رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2390
Fax:
Email: Ghassemi.mr@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasoul akram hospital Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم Full name of responsible person - English: Mohammadreza Ghassemi Full name of responsible person - Persian: محمدرضا قاسمی Street address - English: Rasoul akram hospital, Mansouri street, Sattarkhan Ave Street address - Persian: خیابان ستارخان، خیابان مازیار منصوری، بیمارستان رسول اکرم (ص) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 2390 Fax: Email: Keramatihaniyeh73Ghassemi.mr@gmail.comiums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Kazem Mousavi Zadeh
Full name of responsible person - Persian: کاظم موسوی زاده
Street address - English: Iran university of medical science, Next to Milad tower, Hemmat highway
Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 4837
Fax:
Email: mousavizadeh.k@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reza Falak
Full name of responsible person - Persian: رضا فلک
Street address - English: Iran university of medical science, Next to Milad tower, Hemmat highway
Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8862 2703
Fax:
Email: falak.r@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Kazem Mousavi ZadehReza Falak Full name of responsible person - Persian: کاظم موسوی زادهرضا فلک Street address - English: Iran university of medical science, Next to Milad tower, Hemmat highway Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8670 48378862 2703 Fax: Email: mousavizadeh.kfalak.r@iums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the efficacy and safety of PDL, IPL and long pulse Nd:Yag 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris
Design
A three-arm , parallel-group, without control group, single-blind, randomized, phase 2 clinical trial on 36 patients.
Settings and conduct
The diagnosis is made in the dermatology clinic of Rasool Akram Hospital. Then, the eligible patients are randomly divided into three groups for laser treatment through the selection of non-transparent envelopes, in order to blind the patients to the choice of treatment modality. The first group is treated with a PDL laser with a wavelength of 585 nm, a spot diameter of 7 mm, a fluence of 3 J, and a pulse duration of 350 microseconds. In the second group, patients under treatment with IPL laser with a wavelength of 240-1200 nm and a fluence of 7 J, and in the third group of patients under treatment with a Nd:Yag long pulse laser with a wavelength of 1064 nm and a pulse duration of 40 microseconds and with a fluence of 40 J. Patients are treated with laser in 3 sessions at an interval of 2 weeks in the dermatology clinic of Hazrat Fatemeh Hospital.
Participants/Inclusion and exclusion criteria
Participants over 18 years old with mild to moderate facial inflammatory acne
Not taking isotretinoin in the last 6 months.
Patient satisfaction
No history of hypertrophic scar or keloid
Not taking anticoagulant drug in the last 2 months
No Pregnancy or breastfeeding
No history of Photosensitivity and rheumatologic diseases
Intervention groups
The study does not have a control group. In the first group of patients, three sessions of PDL laser will be treated. In the second group, three sessions of IPL laser will be treated, and in the third group of patients, three sessions of Nd:YAG laser will be treated.
Main outcome variables
Severity of acne lesions,
The number of acne lesions, Quality of life
General information
Reason for update
Due to the lack of long pulse mode on the Nd:YAG device available at the laser center, another mode of the same wavelength, the Q-switch form, has been used.
Acronym
IRCT registration information
IRCT registration number:IRCT20150529022468N6
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2025-12-17, 1404/09/26
Update count:1
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Mohammadreza Ghassemi
Name of organization / entity
Iran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
ghassemi.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-10-01, 1403/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of PDL, IPL and Q switch Nd:YAG 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris
Public title
Comparison of the efficacy and safety of PDL, IPL and long pulse Nd:Yag 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants over 18 years old with mild to moderate facial inflammatory acne
Not taking isotretinoin in the last 6 months.
Exclusion criteria:
History of hypertrophic scar or keloid
Anticoagulant drug consumption in the last 2 months
Pregnancy or breastfeeding
Photosensitivity and rheumatologic diseases
Dissatisfaction of patients
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Over time, patients are randomly divided into three groups. The method of randomization is *Random allocation rule*. A representative of the first, second and third groups is written and placed inside envelopes and in order to perform a random sequence (allocation concealment) on the participants, the table of random numbers will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
A representative of the first, second, and third groups is written and placed inside opaque envelopes (which cannot be seen inside the envelope).
Participant are blinded to the intervention until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran university of medical sciences, Central headquarters building, Research and technology vice-chancellor, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.IUMS.FMD.REC.1402.036
Health conditions studied
1
Description of health condition studied
Infammatory facial Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Leeds revised acne grading system
Timepoint
Checking the severity of acne at the beginning of the study and on days 14, 28 and 42 after the intervention
Method of measurement
Based on the number of lesion in the photo and comparing with "Leeds revised acne grading system" a score of 1-12 is given
Secondary outcomes
1
Description
Severity of inflammatory facial acne
Timepoint
Measuring the criteria of the global acne grading system at the beginning of the study and on the 14th, 28th, and 42nd days after the start of the study
Method of measurement
Based on the type of lesions, from comedone type to papule, pustule and nodulocystic acne, a score is given from 1 to 44
2
Description
Quality of life index
Timepoint
Beginning and end of the study (0 and 42th days)
Method of measurement
"Dermatology Life Quality Index " questionnaire
Intervention groups
1
Description
Intervention group 1: Patients in the first group were treated 3 times with an interval of two weeks with PDL laser with a wavelength of 585 nanometers, laser spot diameter of 7 mm, fluence of 3 joules, and pulse duration of 350 microseconds
Category
Treatment - Devices
2
Description
Intervention group 2: In the second group, patients are treated 3 times with an interval of two weeks with IPL laser with a wavelength of 240-1200 nanometers and fluence of 7 joules.
Category
Treatment - Devices
3
Description
Intervention group 3: In the third group, patients are treated 3 times with an interval of two weeks with Nd: Yag long pulse laser with a wavelength of 1064 nanometers and a fluence of 40 joules and a pulse duration of 40 microseconds.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual Data: All potentially shareable data after de-identifying individuals.
Study protocol: The entire protocol can be shared after de-identifying people.
Statistical analysis map: The whole map can be shared after de-identifying people.
Informed Consent Form: Can be shared after de-identifying individuals.
Clinical Study Report: The entire report can be shared after de-identifying individuals.
Codes used in the analysis: All codes can be shared after de-identifying people.
Data classification system: It can be shared after de-identifying people.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In case of research on a similar topic, he/she can use the data of this study.
From where data/document is obtainable
1- Email: Keramatihaniyeh73@gmail.com
2- Postal address: Rasool Akram Hospital, Mansouri St., Sattar Khan Ave., Tehran
What processes are involved for a request to access data/document
After correspondence via e-mail or postal address, it is possible to receive data and documents within a period of about two months, if the researcher wishes.