Comparison of therapeutic, safety and efficacy effects of topical hydrogen peroxide solution (40% by volume) with cryotherapy in
Seborrheic keratosis lesions
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. Patients will be randomly divided into intervention and control groups using the outpatient file number and the random number table.
Settings and conduct
Sina Hospital, Tabriz, Admission of 90 patients to the study based on inclusion and exclusion criteria and classification into intervention and control groups, double-blind study, classification of patients into groups A and B, patients،lack of information about type of treatment among patients and data analyzer.
Participants/Inclusion and exclusion criteria
1)Age over 18 years
2) Seborrheic keratosis with definitive diagnosis based on diagnostic criteria: (presence of at least one separate lesion on the face and a separate lesion on trunk or limbs with a depth of 0 to 2 mm and a length and width of 5 to 15 mm)
3)Presence of at least 4 seborrheic keratosis lesions in patient
4) Acceptance to participate in the study
Intervention groups
Patients with seborrheic keratosis treated with topical hydrogen peroxide solution
Comparison of therapeutic, immunity and efficacy of topical hydrogen peroxide solution (40% vol) with cryotherapy in seborheic keratosis.
Public title
Comparison of therapeutic, immunity and efficacy of topical hydrogen peroxide solution (40% vol) with cryotherapy in seborheic keratosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Patient with definite diagnosis of seborrheic keratosis according to diagnostic criteria (Existence of at least one separate lesion in the trunk or limbs with a depth of 0 to 2 mm and length and width of 5 to 15 mm)
Existence of at least 4 lesions of seborrheic keratosis in the individual
Satisfaction to participate in the study
Exclusion criteria:
Presence of the lesion at the site of hair growth (so that the medicine does not reach the lesion well)
Presence of a lesion on the eyelid
Lesions at a distance of 5 mm from the eye
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to an outpatient file number and a table of random numbers to two
intervention and control groups will be divided.
Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and has become a table. In order to use random numbers, first determine the table to read the numbers, from left to right, the second assumption is to consider numbers for different groups, even numbers for the intervention group and odd numbers for Control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are divided into two groups A and B and the data analyzer is not aware of the treatment received by each group. Blinding is used to reduce the error rate. In this study, double-masked blinding is used in which both patients and evaluators of patient-related data are unaware of the exposure received. In these studies, the groups are identified by a code A and B, which is placed in an envelope, and elsewhere, it is specified that this group number is an intervention or a control.
Placebo
Not used
Assignment
Parallel
Other design features
Data collection method: The data obtained will be recorded by a data collection form designed by the researcher. Data analysis method: The data obtained by SPSS statistical analysis software version 21 will be statistically analyzed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No. 3, 3rd Floor, East Avang Alley, Parvin Etesami St., Fatemi St., Tehran
City
Tabriz
Province
East Azarbaijan
Postal code
1413845446
Approval date
2020-12-28, 1399/10/08
Ethics committee reference number
IR.TBZMED.REC.1399.914
Health conditions studied
1
Description of health condition studied
Seborrheic keratosis
ICD-10 code
L82
ICD-10 code description
Seborrheic keratosis
Primary outcomes
1
Description
The effectiveness of the treatment will be assessed by the Physician's Lesion Assessment Scale (PLA). The scoring of this scale is 4 numbers (0 = no lesion; 1 = almost no lesion; = Lesions with a depth of more than 1 mm) Patients will be evaluated by this scale at the time of the first visit, 3 weeks later, 6 weeks later and 8 weeks after receiving the treatment. will be.
Timepoint
Physician’s lesion assesment scale measurement at the time of the first visit, 3 weeks later, 6 weeks later and 8 weeks after receiving treatment
Method of measurement
Physician’s lesion assesment scale score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive topical hydrogen peroxide solution (40% by volume). The solution will be applied to the lesion so that it covers the entire surface of the lesion and then held for 20 seconds with rotational movements and pressure on the lesion. This operation is performed for all 4 lesions and the drug will be applied in each session for a total of 80 seconds. This cycle will be repeated 4 times in each session, which will be a total of 320 seconds. Patients will be monitored for pharmacological and dermatological side effects for at least 20 minutes after application of the solution. The effects of treatment, efficacy and safety of medication will be evaluated and in the next 8 weeks visit, patients will be evaluated only for the effects of treatment, efficacy and safety of medication and will not receive intervention.
Category
Treatment - Drugs
2
Description
Control group: Cryotherapy for the control group performed at the first visit, 3 weeks later and 6 weeks later And each time patients will be evaluated for the effects of treatment, efficacy and safety of medication and at the visit 8 weeks later Patients will only be evaluated for the effects of treatment, efficacy and safety of medication and will not receive intervention
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Hossein Garavand
Street address
Tabriz, Azadi St., between Shahid Montazeri and Hafez intersections, Sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
hossein.garavand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiee
Street address
thired floor, central billing number two, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
Samiei.moh@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
Armaghan Gharehaghajizare
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi street, Sina hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138665789
Phone
+98 41 3549 8236
Email
Ghareaghajia@tbmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Armaghan Ghareh aghaji zare
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi street, Sina hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138665789
Phone
+98 41 3549 8236
Email
Ghareaghajia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Armaghan Ghareh aghaji zare
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi street, Sina hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138665786
Phone
+98 41 3549 8236
Email
Ghareaghajia@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
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 results 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.