Efficacy, safety, satisfaction, toleberility and treatment duribility of long-pulsed Nd:YAG 1064 nm laser compared with fractional Q-switch Nd:YAG 1064 nm laser in the treatment of active acne vulgaris in patients under treatment with azithromycine: An assessor-analyst-blinded split-body triple-arms randomized controlled clinical trial
Determining of effectiveness of fractional Q switch laser compared with Nd:YAG laser in the treatment of active acne of face
Design
Clinical trial with control group, Single-blind , randomized on 20 patients, simple randomization was used for randomization
Settings and conduct
In all patients who entered the study with active acne, before the start of the study, using Canon EOS 750D digital photography camera with the same distance and high quality, the desired images of the patients will be prepared.
Each patient is treated with laser for three sessions with an interval of 3 weeks, and evaluation is done at each visit and 4 weeks after the last laser session. Evaluation of the study results by an evaluator blinded to the type of intervention and based on the images prepared by Waste will be done in each meeting.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are according to the following:
1. Patients 15 to 50 years old
2. Patients with a confirmed diagnosis of active facial acne
3. The patient has not received any treatment for his illness in the past three months.
4. Lack of serious underlying disease
5. The patient's cooperation in carrying out therapeutic interventions and referring for all therapeutic sessions
Intervention groups
The study population is patients with moderate to severe active facial acne referring to Hazrat Rasool Akram Hospital. Affected patients were examined by a dermatologist, and if there were entry criteria and no exit criteria, they were entered into the plan by the available method, and for each patient, fractional Kioswitch laser was performed on one side of the face and Nd:YAG laser on the opposite side. will be Also, forehead or trunk acne of the patient is considered as a control group.
Main outcome variables
Effectiveness of treatment; Safety of treatment; Tolerability of treatment; Satisfaction with treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035597N4
Registration date:2023-06-10, 1402/03/20
Registration timing:prospective
Last update:2023-06-10, 1402/03/20
Update count:0
Registration date
2023-06-10, 1402/03/20
Registrant information
Name
Azadeh Goodarzi
Name of organization / entity
Iran University of Medical Sciences (IUMS), Rasool Akram hospital, Department of Dermatology
Country
Iran (Islamic Republic of)
Phone
+98 66502040
Email address
goodarzi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy, safety, satisfaction, toleberility and treatment duribility of long-pulsed Nd:YAG 1064 nm laser compared with fractional Q-switch Nd:YAG 1064 nm laser in the treatment of active acne vulgaris in patients under treatment with azithromycine: An assessor-analyst-blinded split-body triple-arms randomized controlled clinical trial
Public title
effect of fractional Q switch laser compared with Nd:YAG laser in the treatment of active acne of face: a single-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient between 15 and 50 years old
Patients with a confirmed diagnosis of facial active acne
During the last 3 months, the patient has not received any treatment for the disease.
Lack of underlying disease
The patient's cooperation in carrying out therapeutic interventions and referring for all therapeutic sessions
Exclusion criteria:
The patient has been treated for acne in the last three months
The presence of a serious underlying disease in the person
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
3
For each patient, fractional Q-switch laser is performed randomly on one side of the face and Nd:YAG laser on the opposite side.Also, forehead or trunk acne of the patient is considered as a control group.
Randomization (investigator's opinion)
Randomized
Randomization description
For each patient in a random way and using sealed envelopes A and B, on one side of the face,will treated with fractional Q-switch laser and on the opposite side, Nd:YAG laser. The right side of the face of group A will treaated with Q-switch laser and the left side will treated with Nd:YAG laser and vice versa. Also, the patient's forehead or trunk acne is considered as a control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of the results of the studies will be done by a dermatologist as a blind evaluator to the type of intervention and based on the clinical images of the patients' faces in each session. Due to the clear difference between the mentioned therapeutic interventions, it was not possible to blind the therapist and as a result, the study will be conducted in a one-sided blind manner.
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
Rasoul Akram Hospital, At the corner of Mansouri St,Niyayesh St, Satarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.IUMS.FMD.REC.1402.074
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
Acne vulga
ICD-10 code description
L70.0
Primary outcomes
1
Description
Effectiveness of laser treatment on acne
Timepoint
Determining the severity of acne at the beginning of treatment and 4 weeks after the end of treatment
Method of measurement
Clinical evaluation by photographing with Canon EOS 750D digital photography camera in room light and also counting the number of active lesions 2. Determination of acne severity using Leeds revised acne grading system which is based on the lesions in the photo and comparing with existing criteria from 1 to 12 The severity of acne is scored. 3. Examining the severity of acne using the global acne grading system) which is based on the location of acne lesions on the face and also based on the type of lesions from comedone type to papule, pustule and nodulocystic acne with a score from 1 to 44 It is considered that grade 1 to 18 is mild, 19 to 30 is moderate, 31 to 38 is severe, and a grade equal to or greater than 39 is considered very severe.4. The degree of satisfaction of the doctor and the patient with the treatment based on the physician/patient global assessment score: (completely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and completely dissatisfied)The photos are reviewed and scored by a dermatologist who is blind to the study, and at the end, the study data is analyzed by a blind statistician.
2
Description
Safety of treatment
Timepoint
Examination of treatment side effects before and after each session and 4 weeks after the end of treatment
Method of measurement
Using doctor and patient questionnaires (including pain, swelling, erythema and PIH)
3
Description
Tolerability of the treatment
Timepoint
Checkiing the tolerability of the treatment before and after each session and 4 weeks after the end of the treatment
Method of measurement
Using a questionnaire (yes, no)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The study population is patients with moderate to severe active facial acne referring to Hazrat Rasool Akram Hospital. Affected patients were examined by a dermatologist, and if there were entry criteria and no exit criteria, they were entered into the plan by the available method, and for each patient, fractional Q-switch laser was performed on one side of the face and Nd:YAG laser on the opposite side.Randomization is done by sealed envelopes. Each patient is treated with laser for three sessions with an interval of 3 weeks. Fractional Qswitch laser settings: Pulse rate: 10 Hz, spot size: 10 mm, fluence: 1.5 j/cm2 1064 nm Nd:YAG laser settings: Pulse rate: 4 Hz, spot size: 6 mm, fluence: 60 j/cm2.Evaluation is done in each laser sessions and 4 weeks after the last laser appointment.
Category
Treatment - Devices
2
Description
Control group: Acne on the forehead or trunk of the patient is considered as the control group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dorian Maghsoodloo
Street address
Rasoul Akram Hospital , Mansouri St , Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 912 202 7398
Email
Maghsoodloodorian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Iran University of Medical Sciences , Hemmat highway , Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh goodarzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Rasoul Akram hospital ,Mansouri St, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2390
Email
Goodarzi.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Goodarzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Rasoul Akram Hospital, Mansouri St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
009864352421
Email
Goodarzi.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Goodarzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Rasoul Akram Hospital, Mansouri St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2421
Email
Goodarzi.a@iums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available