Assessing the effect of Nd-YAG laser on moderate acne and its effect of acne induced eryhtema and scar
Design
Clinical trial with a control group, with parallel groups, without blindness, randomized, phase 2 on 21patients. The SealedEnvelope website would be used for randomization.
Settings and conduct
This research will be done in the laser department of Razi Hospital. Nd-YAG laser will be applied on one side of the patient's face every 2 weeks for 4 times. Considering that blinding is not possible, the only blind person in this study would be the analyst.
Participants/Inclusion and exclusion criteria
Inclusion: Aged 18-60 Clinical diagnosis of moderate acne by a dermatologist
Non inclusion: Pregnancy or breastfeeding during the intervention.
History of internal diseases, including endocrine diseases causing acne. Alteration in diet and lifestyle during the study.
Having consumed systemic therapy for acne in the last 4 weeks.
Having consumed oral antibiotics in the last 3 months Having consumed topical therapy for acne in the last 2 weeks.
Having consumed isotretinoin, undertaken laser, and peeling in the last 6 months.
Photosensitivity.
Severe or nodularis acne.
Polycystic ovary syndrome
Intervention groups
The first intervention group: one side of the patient's face receiving Nd-YAG laser. And the second intervention group (control): the other side of the patient's face that does not receive laser.
Main outcome variables
Acne severity; Patients' satisfaction with acne recovery; Laser complications; patient pain during laser therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181005041243N3
Registration date:2022-10-15, 1401/07/23
Registration timing:prospective
Last update:2022-10-15, 1401/07/23
Update count:0
Registration date
2022-10-15, 1401/07/23
Registrant information
Name
Nika Kianfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 7201
Email address
N-kianfar@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of adjuvant Nd-Yag laser in the long-term treatment of moderate inflammatory acne and its effect on acne induced erythema and scar
Public title
Efficacy of adjuvant Nd-Yag in acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18-60
Clinical diagnosis of moderate acne by a dermatologist
Exclusion criteria:
Pregnancy or breastfeeding during the intervention
history of internal diseases, including endocrine diseases causing acne
Alteration in diet and lifestyle during the study
Having consumed systemic therapy for acne in the last 4 weeks
Having consumed oral antibiotics in the last 3 months
Having consumed topical therapy for acne in the last 2 weeks
Having consumed isotretinoin, undertaken laser, and peeling in the last 6 months
Photosensitivity
Severe or nodularis acne
Polycystic ovary syndrome
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
21
More than 1 sample in each individual
Number of samples in each individual:
2
Of side of the face, based on randomization, would receive laser therapy, while the other side would not receive laser therapy
Randomization (investigator's opinion)
Randomized
Randomization description
Individual blocks will be created without stratified randomization by statistical software. And another person (rather than the doctor-researcher-patient) would do the randomization.
For this, blocks of size 6 were selected for 2 treatment groups (one side of the face receiving laser treatment and the other side without treatment as a control group) so that the total sample size is 24.
Accordingly, patients will receive each treatment based on the randomized sequence.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Vahdate eslami St. - Razi alley. Razi Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
119963911
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.346
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Acne severity
Timepoint
At the first session and then 2 and 5 months after that
Method of measurement
Acne severity will be assessed based on Hayashi acne grading/ based on the observations of two dermatologists assessing the before and after photographs
2
Description
Acne scarring
Timepoint
At the first session and then 2 and 5 months after that based on the size of the scarring in millimeters
Method of measurement
Acne scarring will be assessed based on The Goodman quantitative postacne scarring grading system / based on the observations of two dermatologists assessing the before and after photographs
3
Description
Pain scoring during laser
Timepoint
At each treatment session (4 times)
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
The side effects of laser therapy, including erythema, edema, and blisters
Timepoint
It would be evaluated after each treatment session.
Method of measurement
Dermatologist's visit and patients statements
Intervention groups
1
Description
Intervention group: Nd-YAG laser is treated on one side of the patient's face with setting and PD=25 ms and SS=4 mm. The treatment session would be 4 times every two weeks.
Category
Treatment - Devices
2
Description
Control group: The other side of the face would receive no laser therapy.
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
Nika Kianfar
Position
Post doc researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.1, afshar alley, daavi alley, pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1947873416
Phone
+98 21 5563 0553
Fax
Email
n-kianfar@alumnus.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Nasimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Dermatology Hospital, Razi alley, Vahdate eslami St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
nsm.maryam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Post doc researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.1, afshar alley, daavi alley, pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1947873416
Phone
+98 21 2285 7201
Fax
Email
n-kianfar@alumnus.tums.ac.ir
Sharing plan
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
Undecided - It is not yet known if there will be 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
The data file information of the participants - study protocol - statistical analysis plan - informed consent form will be published after de-identification.
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
Receiving data will be available for researchers working in academic and scientific institutions or people who are also engaged in industry
Under which criteria data/document could be used
In order to conduct scientific studies
From where data/document is obtainable
Dr. Nika Kianfar nika_kianfar@yahoo.com
What processes are involved for a request to access data/document
After sending the request by providing a logical reason, the data will be sent to the person within 2 weeks.