Protocol summary
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Study aim
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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
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Design
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A three-arm , parallel-group, without control group, single-blind, randomized, phase 2 clinical trial on 36 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Severity of acne lesions,
The number of acne lesions, Quality of life
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-08-12, 1402/05/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-10-02, 1402/07/10
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Expected recruitment end date
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2024-10-01, 1403/07/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-04-18, 1402/01/29
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Ethics committee reference number
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IR.IUMS.FMD.REC.1402.036
Health conditions studied
1
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Description of health condition studied
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Infammatory facial Acne vulgaris
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ICD-10 code
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L70.0
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ICD-10 code description
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Acne vulgaris
Primary outcomes
1
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Description
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Leeds revised acne grading system
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Timepoint
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Checking the severity of acne at the beginning of the study and on days 14, 28 and 42 after the intervention
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Method of measurement
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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
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Description
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Severity of inflammatory facial acne
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Timepoint
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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
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Method of measurement
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Based on the type of lesions, from comedone type to papule, pustule and nodulocystic acne, a score is given from 1 to 44
2
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Description
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Quality of life index
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Timepoint
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Beginning and end of the study (0 and 42th days)
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Method of measurement
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"Dermatology Life Quality Index " questionnaire
Intervention groups
1
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Description
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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
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
3
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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The data will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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In case of research on a similar topic, he/she can use the data of this study.
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From where data/document is obtainable
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1- Email: Keramatihaniyeh73@gmail.com
2- Postal address: Rasool Akram Hospital, Mansouri St., Sattar Khan Ave., Tehran
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What processes are involved for a request to access data/document
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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.
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Comments
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