Comparison of the plasma effect with and without alexandrite laser in the treatment of freckles in patients referred to the clinics affiliated with Tehran Medical Sciences Azad University in 2022-2023
Comparison of plasma efficacy with and without alexandrite laser in the treatment of freckles
Design
A single-blind, randomized clinical trial of 60 patients
Settings and conduct
60 patients with bilateral facial freckles with Fitzpatrick skin type 1 to 4 are treated.
A group of 30 patients are treated with single pass plasma and another group of 30 patients are treated with plasma and Cynasure Alexandrite laser.
After the treatment, the patient uses zinc oxide daily and eye erythromycin daily for 5 days, and then uses sunscreen with SPF 50 twice a day until at least one month after the treatment. The patients are examined after one month and if necessary, we perform the mentioned treatments once more and finally the clinical improvement and side effects are evaluated by dermatologist.
-Place of performance in clinics affiliated to Azad University, Tehran Medical Branch
Participants/Inclusion and exclusion criteria
Inclusion criteria: -Patients with freckles, Skin type 1 to 4 of the Fitzpatrick scale, People over 16 years old
Exclusion criteria: - Use of skin lightening drugs 8 weeks prior to treatment, Skin type 5 of the Fitzpatrick scale, Patients exposed to direct UV light, Patients under 16 years old
Intervention groups
A group of 30 patients are treated with single pass plasma and another group of 30 patients are treated with plasma and Alexandrite Signasure laser
Main outcome variables
Evaluation of the responsiveness of pigmented lesions to plasma with and without alexandrite laser
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230103057039N1
Registration date:2023-04-06, 1402/01/17
Registration timing:retrospective
Last update:2023-04-06, 1402/01/17
Update count:0
Registration date
2023-04-06, 1402/01/17
Registrant information
Name
Mahin Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4613 8218
Email address
mahin.pt86@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-27, 1401/11/07
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the plasma effect with and without alexandrite laser in the treatment of freckles in patients referred to the clinics affiliated with Tehran Medical Sciences Azad University in 2022-2023
Public title
Evaluation of the efficacy of laser and plasma in the treatment of freckles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having freckles
Skin types 1 to 4 on the Fitzpatrich scale
Patient over 16 years old
Exclusion criteria:
Taking skin lightening drugs 8 weeks before treatment
Fitzpatrick scale type 5 skin
People who are directly exposed to UV light
People under 16 years old
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of the results of the interventions is done by a dermatologist and this study is blinded by her
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine,Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters Building of Islamic Azad University of Medical Sciences Tehran,Corner of Ice Flower Street,Ayeneh Boulevard, Dr. Shariati Street
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.IAU.TMU.REC.1401.322
Health conditions studied
1
Description of health condition studied
Patients with freckles
ICD-10 code
L81.2
ICD-10 code description
Freckles
Primary outcomes
1
Description
Degree of pigmentation
Timepoint
Before and after the intervention
Method of measurement
Based on the reduction of pigmentation: Weak, Medium, Excellent
2
Description
Side effects
Timepoint
A month after the treatment is finished
Method of measurement
Ask the patient
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: A group of 30 patients with fitzpatrick skin type 1 to 4 who had no history of using topical lightening drugs from 8 weeks before treatment, without sexual restriction, over 16 years old, will be treated with plasma single pass. The amount of skin pigmentation in two stages before and after treatment is determined. The response to treatment will be complete loss of lesions (recovery above 80%).
Category
Treatment - Devices
2
Description
Second group of intervention: A group of 30 patients with fitzpatrick skin type 1 to 4 who had no history of using topical lightening drugs from 8 weeks before treatment, without sexual restriction ,over 16 years old will be treated with plasma single pass with a single pass laser shot with a wavelength of 755 nm with a wavelength of 5 mm and Pulse duration of 0.5 milisecond with Fluence = 20 J/cm2 for skin type 3 and 4 /Fluence = 24 J/cm2 for skin type 1 and 2 in single pass. The amount of skin pigmentation in two stages before and after treatment is determined. The response to treatment will be complete loss of lesions (recovery above 80%).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Farhikhtegan Hospital
Full name of responsible person
Dr Setareh Tehrani
Street address
University Square,The northern end of Satari
City
Tehran
Province
Tehran
Postal code
1477899676
Phone
+98 21 4486 7262
Fax
+98 21 4484 5171
Email
farhikhteganhospital@gmail.com
2
Recruitment center
Name of recruitment center
Azad University Quds Clinic
Full name of responsible person
Dr Setareh Tehrani
Street address
No. 1 - Qods Town (West) - End of Phase 6 -Tehran
City
Tehran
Province
Tehran
Postal code
1495/19395
Phone
+98 21 8807 8388
Fax
Email
Int.affairs@iautmu.ac.ir
Web page address
http://tms.iau.ir/ghods
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Farshad Hashemian
Street address
Headquarters Building of Islamic Azad University of Medical Sciences Tehran Corner of Ice Flower Street,Dr. Shariati Street,Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2643
Email
Int.affairs@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mahin Fathi
Position
Medical Intern
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No. 2,Arash street, Park Ave, Hamila Blvd, Punak
City
Tehran
Province
Tehran
Postal code
1469696006
Phone
+98 21 4613 8218
Email
mahin.pt86@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahin Fathi
Position
Medical Intern
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No.7, Arash street, Park Ave,Hamila Blv,Punak
City
Tehran
Province
Tehran
Postal code
1469696006
Phone
+98 21 4613 8218
Email
mahin.pt86@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahin Fathi
Position
Medial Intern
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No.2, Arash street, Park Ave, Hamila Blv, Punak
City
Tehran
Province
Tehran
Postal code
1469696006
Phone
+98 21 4613 8218
Email
mahin.pt86@yahoo.com
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