Determining the benefits and side effects of the Nd:YAG 1064 nm laser in order to achieve an effective pulse width with minimal side effects in the treatment of the face and lower limb telangiectasia
Determining the benefits and side effects of the Nd:YAG 1064 nm laser in order to achieve an effective pulse width with minimal side effects in the treatment of face and lower limb telangiectasia
Design
Phase 3 non-randomized clinical trial on 70 patients with parallel groups and single-blinded
Settings and conduct
A sample of patients with telangiectasias of the face and lower limbs who have visited the skin clinic of the Sina educational, research and therapeutic center in Tabriz will be selected and introduced to the outpatient dermatology operating room of the center for laser treatment.
Participants/Inclusion and exclusion criteria
Patients with facial telangiectasia as well as patients with lower limb telangiectasia between the ages of 18 and 50 will be included in the study. Pregnant and lactating women, patients with a history of coagulation disorders, chronic systemic liver diseases, and patients with a history of hypertrophic scars and prone to keloid will be excluded from the study.
Intervention groups
For the treatment of facial telangiectasia, two fluences of 140 and 150 J/cm2 with a pulse width of 20 milliseconds and a spot size of 3 mm2 and for the lower limbs from two fluences of 160 and 180 J/cm2 with a pulse width of 20 milliseconds and a spot The size of 5 mm square will be used.
Main outcome variables
Telangiectasia recovery rate; Patient satisfaction; Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100314003566N13
Registration date:2023-12-02, 1402/09/11
Registration timing:prospective
Last update:2023-12-02, 1402/09/11
Update count:0
Registration date
2023-12-02, 1402/09/11
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the benefits and side effects of the Nd:YAG 1064 nm laser in order to achieve an effective pulse width with minimal side effects in the treatment of the face and lower limb telangiectasia
Public title
Benefits of Nd:YAG 1064 nm laser in the treatment of the face and lower limb telangiectasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with facial telangiectasia
Patients with telangiectasia of lower limbs
Consent to participate in the study
Exclusion criteria:
Pregnant and lactating women
Patients with a history of coagulation disorders
Suffering from chronic systemic liver diseases
Patients with a history of hypertrophic scars and prone to keloid
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The degree of fluency, pulse width, and spot size utilized will be kept secret from patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
IR.TBZMED.REC.1402.609
Health conditions studied
1
Description of health condition studied
Facial telangiectasia
ICD-10 code
I78.0
ICD-10 code description
Hereditary hemorrhagic telangiectasia
2
Description of health condition studied
Lower limb telangiectasia
ICD-10 code
I78.0
ICD-10 code description
Hereditary hemorrhagic telangiectasia
Primary outcomes
1
Description
Recovery rate of telangiectasia
Timepoint
Patients will be examined at baseline, 4 weeks after the first treatment, 4 weeks after the second treatment, and 4 weeks after the last evaluation.
Method of measurement
Dermoscopy imaging
2
Description
Patient satisfaction
Timepoint
Patients will be examined at baseline, 4 weeks after the first treatment, 4 weeks after the second treatment, and 4 weeks after the last evaluation.
Method of measurement
Interview with patients
3
Description
Side effects
Timepoint
Patients will be examined at baseline, 4 weeks after the first treatment, 4 weeks after the second treatment, and 4 weeks after the last evaluation.
Method of measurement
Including wounds, scars, erythema, hyperpigmentation, hypopigmentation and blisters, which will be evaluated by a clinical examination by a dermatologist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients with facial telangiectasia treated with alexandrite laser with a wavelength of 1064 nm (Alexandrite ND: YAG, CA, USA) with fluence parameters of 140 and 150 J/cm2 with a pulse width of 20 milliseconds and a spot size of 3 mm will be squared. Before the treatment, anesthesia will be done with a thin layer of topical gel on the surface of the skin. Also, after laser treatment, sunscreen and repair cream will be used in all patients for at least 10 days.
Category
Treatment - Devices
2
Description
Intervention group 2: Patients with lower limb telangiectasia treated with alexandrite laser with a wavelength of 1064 nm (Alexandrite ND: YAG, CA, USA) with fluence parameters of 160 and 180 J/cm2 with a pulse width of 20 milliseconds and a spot size of 5 mm will be squared. Before the treatment, anesthesia will be done with a thin layer of topical gel on the surface of the skin. Also, after laser treatment, sunscreen and repair cream will be used in all patients for at least 10 days.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Dr.Hamideh Azimi
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3541 2103
Email
azimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
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
No - There is not 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.