Effect of topical solution hydrogen peroxide 40% versus cryotherapy on the treatment of seborrheic keratosis lesions: a single-blind randomized clinical trial
To assess the effect of topical solution hydrogen peroxide 40% versus cryotherapy on the treatment of seborrheic keratosis lesions
Design
This is a Phase III single-blind randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 40 eligible patients with seborrheic keratosis lesions. The right and left sides of the patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Bilateral facial seborrheic keratosis
Exclusion criteria:
Pregnancy or breastfeeding
History of using anti-pigmentation drugs in the last 3 months
Presence of wound, infection or active skin disease at the treatment site
Lesions on the eyelids or around the eyes
Intervention groups
Intervention group:
In the hydrogen peroxide treatment method, a 40% hydrogen peroxide solution is placed on the seborrheic keratosis lesions with a cotton swab for 20 seconds and repeated after 60 seconds. This treatment is repeated once a week for 6 weeks.
Control group:
In the cryotherapy treatment method, a cotton swab dipped in liquid nitrogen is placed on the seborrheic keratosis lesions with a margin of 1 to 2 mm from the surrounding healthy skin until it is frozen and after complete melting, this operation is repeated again. This treatment is repeated every two weeks for 6 weeks.
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical solution hydrogen peroxide 40% versus cryotherapy on the treatment of seborrheic keratosis lesions: a single-blind randomized clinical trial
Public title
Effect of topical solution hydrogen peroxide 40% versus cryotherapy on the treatment of seborrheic keratosis lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Bilateral facial seborrheic keratosis
Exclusion criteria:
Pregnancy or breastfeeding
History of using anti-pigmentation drugs in the last 3 months
Presence of wound, infection or active skin disease at the treatment site
Lesions on the eyelids or around the eyes
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of the right and left sides of the patients to the intervention and control groups will be carried out using the drawing of lots. To achieve this, two sheets will be prepared, one with "right" written on it and the other with "left." For each patient, one sheet will be randomly taken from the container. Based on whether the given sheet is labeled as "right" or "left," it will be assigned to the intervention group or the opposite side will be allocated to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.UMSHA.REC.1402.490
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
Improvement rate of keratosis seborrheic lesions
Timepoint
In 2, 4, and 6 weeks after treatment
Method of measurement
By clinical examination
Secondary outcomes
1
Description
Pain and burning
Timepoint
20 minutes after treatment
Method of measurement
By taking history
2
Description
Erythema
Timepoint
20 minutes after treatment
Method of measurement
With clinical examination
3
Description
Edema
Timepoint
20 minutes after treatment
Method of measurement
With clinical examination
4
Description
Hypopigmentation
Timepoint
20 minutes after treatment
Method of measurement
With clinical examination
5
Description
Hyperpigmentation
Timepoint
20 minutes after treatment
Method of measurement
With clinical examination
Intervention groups
1
Description
Intervention group: In the hydrogen peroxide treatment method, a 40% hydrogen peroxide solution is placed on the seborrheic keratosis lesions with a cotton swab for 20 seconds and repeated after 60 seconds. This treatment is repeated once a week for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: In the cryotherapy treatment method, a cotton swab dipped in liquid nitrogen is placed on the seborrheic keratosis lesions with a margin of 1 to 2 mm from the surrounding healthy skin until it is frozen and after complete melting, this operation is repeated again. This treatment is repeated every two weeks for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Forough Bouryabaf
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
foroughbouryabaf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Forough Bouryabaf
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
foroughbouryabaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Ebrahimi
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
b.ebrahimi.4362@googlel.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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