Study of a randomized clinical trial to evaluate the therapeutic effects of Spark plasma on seborrheic keratosis and compare it with cryotherapy
Design
Half of the lesions of patients with spark plasma
And the other half will be done with cryotherapy by swab soaked in liquid nitrogen with two cycles of 15 seconds with the formation of a millimeter frame. Choosing the side that will be treated with plasma will be random and lucky.
Patients will be evaluated at each visit after the physician assessment scale procedure, so that based on the examination, the patient's lesion will be given a score of 0 to 3.
1 = The lesion is relatively gone
2 = Residual thin lesion with a depth of one millimeter or less
3 = depth of more than one millimeter
Patients will be evaluated in four visits with an interval of three weeks, ending in day 84
A statistical evaluation criterion for observing seborrheic thickness at a specific point and time is PLA scale
Settings and conduct
Half of the patients will have plasma spark lesions and the other half will receive cryotherapy
Participants/Inclusion and exclusion criteria
1-People over 18 years old
2- Has at least 4 typical and fixed seborrheic keratosis lesions
3- In logic, the lesions should not be under the pressure of the body
Intervention groups
The efficacy assessment is based on th Physician’s Lesion
Assessment e of the 84th day visit.
Primary analysis based on the percentage of patients in each group whose 4 lesions received a zero or clear score (on day 84) Secondary analysis based on the percentage of patients in each group whose at least 3 of their 4 lesions received a zero or clear score
Main outcome variables
Gender age
Number of waste seborrheic keratosis
Patient skin color
pla
Erosion
Ulcer
Swelling
Crust
Erythema
Vesicles / bullae
Postinflammatory hyperpigmentation
Postinflammatory hypopigmentation
atrophy
scarring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200929048882N1
Registration date:2021-03-12, 1399/12/22
Registration timing:prospective
Last update:2021-03-12, 1399/12/22
Update count:0
Registration date
2021-03-12, 1399/12/22
Registrant information
Name
Maryam Noorbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5549 3124
Email address
dr.maryamnoorbakhsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of plasma spark with cryotherapy in Improving seborrheic keratosis in multiple patient
Public title
spark in seborrheic keratosis. Effect of cryotherapy in treatment of seborrheic keratosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age
At least 4 lesions
Exclusion criteria:
Lesions in areas under pressure of the body
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
54
More than 1 sample in each individual
Number of samples in each individual:
4
clinically typical, discrete SKs that weremore than 0 to 2 mm thick and 5 to 15 mm in lengthand width.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
و performed as a randomization block in such a way that two people who are going to check the rat information are not aware of the randomization block, so they do not know which side of the cryo lesions and which side is sparked, but according to this The nature of the drug is different, the person performing the procedure and the patient are aware of the type of procedure performed, and this is due to the nature of the procedures used.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Thics committee of tehran University of Medical Sciences
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.573
Health conditions studied
1
Description of health condition studied
seborrheic keratosis
ICD-10 code
L82.1
ICD-10 code description
Other seborrheic keratosis
Primary outcomes
1
Description
PLA) scale, which is a proprietary,validated, 4-ordinal number scale (0, clear [no visibleSKs]; 1, nearly clear; 2, a thin SK 1 mm or less indepth; and, 3, a thick SK more than 1 mm in depth)developed to quantify the effect treatment of the SK
Timepoint
Four visits will be evaluated three weeks apart at the end of day 84
Method of measurement
observation of dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
The device used in this study is used using a device with the brand name "PAA Plasma Pen"; This device works in three different modes, one of which is Spark production mode. Voltage range varies between 2 to 8 kV and its frequency is 80 kHz and has a power of 0 to ten watts.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Maryam noorbakhsh sabet
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
dr.maryamnoorbakhsh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeian
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
maryamdansh.pj@gmail.com
Grant name
Grant code / Reference number
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
Maryam noorbakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
dr.maryamnoorbakhsh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam noorbakhsh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
dr.maryamnoorbakhsh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Noorbakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
dr.maryamnoorbakhsh@gmail.com
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
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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
from 2021
To whom data/document is available
dermatologists
Under which criteria data/document could be used
Therapeutic applications of plasma spark in dermatology
From where data/document is obtainable
vahdat eslami Aven Razi hosptial
What processes are involved for a request to access data/document
The data will be visible for up to a week after submitting the request