Comparison between efficacy and safety of cryosurgery versus electrocautery versus CO2 and Erbium:YAG laser in the treatment of facial seborrheic keratoses
Design
Single blind, randomized controlled clinical trial
Settings and conduct
4 similar facial seborrheic keratoses are randomly chosen and treated with one of the mentioned modalities in the Dermatology Clinic of shohada-e Tajrish Hospital. After 2 and 8 weeks, outcome assessment is done based on photographs, by 2 dermatologists who are unaware the treatment strategy used for each lesion.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Age 35 to 85
2-All participants should have at least 4 seborrheic keratoses with similar size and thickness on face.
Exclusion criteria:
1-History of keloid
2-History of coagulopathy or anticoagulant treatment
3-Uncontrolled diabetes
4-Uncontrolled hypertension
5-Active infection on face
6-Non-compliance with treatment and follow ups
7-History of autoimmune connective tissue disease
8-Known allergy to lidocaine or tetracaine
9-Cold intolerance
10-Cryoglobulinemia
11-Cold urticaria and any kind of cold rash
Intervention groups
Control group 1: Electrodessication with the same parameters on seborrheic keratosis lesions. The electrodessication is performed by the mode of biterminal, monopolar and with low energy.
Control group 2: Cryosurgery with the same parameters on seborrheic keratosis lesions. Cryotherapy is performed with application of liquid nitrogen with an open-spray for a single 10 to 15 second freeze–thaw cycle.
Intervention group 1: Er:YAG laser with the same parameters on seborrheic keratosis lesions.
Intervention group 2: Co2 laser with the same parameters on seborrheic keratosis lesions.
Main outcome variables
Recovery rate of seborrheic keratosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141228020468N5
Registration date:2019-09-11, 1398/06/20
Registration timing:registered_while_recruiting
Last update:2019-09-11, 1398/06/20
Update count:0
Registration date
2019-09-11, 1398/06/20
Registrant information
Name
Reza Robati
Name of organization / entity
Skin Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
rezarobati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of efficacy and safety of cryosurgery, electrocoagulation, CO2 laser and Erbium:YAG laser in the treatment of seborrheic keratoses
Public title
Efficacy and safety of different modalities in the treatment of seborrheic keratosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35 to 85
All participants should have at least 4 seborrheic keratoses with similar size and thickness on face
Exclusion criteria:
History of keloid
History of coagulopathy or anticoagulant treatment
Uncontrolled diabetes
Uncontrolled hypertension
Active infection on face
Non-compliance with treatment and follow ups
History of autoimmune connective tissue disease
Known allergy to lidocaine or tetracaine
Cold intolerance
Cryoglobulinemia
Cold urticaria and any kind of cold rash
Age
From 35 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
4 seborrheic keratoses with similar size and thickness on the patients face are randomly chosen and numbered from 1 to 4 and written on a set of cards ;treatment modalities are also randomly named A,B,C or D and written on another set of cards.A blinded person chooses a number from 1 to 4 from the first group and a letter from the second group representing the treatment modality.
Blinding (investigator's opinion)
Single blinded
Blinding description
In our study investigators and the assessors of the outcomes are also unaware of the study groups.
4 seborrheic keratoses with similar size and thickness on the patients face are randomly chosen and numbered from 1 to 4 and written on a set of cards ;treatment modalities are also randomly named A,B,C or D and written on another set of cards.A blinded person chooses a number from 1 to 4 from the first group and a letter from the second group representing the treatment modality.Assessment of the final results is done by 2 dermatologists who are unaware of the treatment used for any of the lesions and is based on the photographs .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Skin Research Center, Shahid Beheshti University of Medical Sciences
Street address
Skin Research Center,Shohada-e Tajrish Hospital, Tajrish square,Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2019-04-14, 1398/01/25
Ethics committee reference number
IR.SBMU.SRC.REC.1398.003
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 rate of recovery of seborrheic keratosis
Timepoint
Before the intervention and 2, 8 weeks after the intervention
Method of measurement
Photography before procedure and in follow up intervals, patient satisfaction
Secondary outcomes
1
Description
Pain
Timepoint
Immediately after the intervention and 2, 8 weeks after the intervention
Method of measurement
Asking the patients
2
Description
Dyspigmentation
Timepoint
Before the intervention and 2, 8 weeks after the intervention
Method of measurement
Evaluation of patients photographs by two dermatologists
3
Description
Scar
Timepoint
Before the intervention and 2, 8 weeks after the intervention
Method of measurement
Evaluation of patients photographs by two dermatologists
4
Description
Keloid formation
Timepoint
Before the intervention and 2, 8 weeks after the intervention
Method of measurement
Evaluation of patients photographs by two dermatologists
5
Description
Infection
Timepoint
2, 8 weeks after the intervention
Method of measurement
Asking the patients
Intervention groups
1
Description
Control group 1: Electrodessication with the same parameters on seborrheic keratosis lesions. The electrodessication (electrosurgical unit, MEG1, Iran Kavandish System co, made in Iran, 2013) is performed by the mode of biterminal monopolar on seborrheic keratosis lesions with the same parameters and with low energy in one treatment session.
Category
Treatment - Devices
2
Description
Control group 2: Cryosurgery with the same parameters on seborrheic keratosis lesions. In all patients, cryotherapy is performed with the application of liquid nitrogen with an open-spray for a single 10 to a 15-second freeze-thaw cycle and in one treatment session.
Category
Treatment - Devices
3
Description
Intervention group 1: Er: YAG laser with the same parameters on seborrheic keratosis lesions. The next device used is Er: YAG laser, LOTUS II erbium device (LOTUS II; Laseroptek Co., Ltd., Sungnam, Gyenggido, Korea). We applied the energy of 500 MJ, with a spot size of 4 mm. All lesions were treated in one session and they received the same amount of energy, fluence, pulse duration, and spot size.
Category
Treatment - Devices
4
Description
Intervention group 2: Co2 laser with the same parameters on seborrheic keratosis lesions. The CO2 laser used in the study is a fractional CO2 laser (Mixel; Hironic Co., Ltd, Korea). We applied the energy of 1.5 J / cm2, pulse duration of 0.4 sec and spot size of 4 mm. All lesions were treated in one session and they received the same amount of energy, fluence, pulse duration, and spot size.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-e Tajrish hospital
Full name of responsible person
Dr Reza Robati
Street address
Skin Research Center, Shohada-E- Tajrish Educational Hospital, Qods Sq. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1508
Email
rezarobati@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Zaresharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9982
Email
shirin.zsharifi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Reza Robati
Position
Associate Professor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2274 1508
Email
rezarobati@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Zaresharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Shirin.zsharifi@sbmu.ac.ir
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 collected demographic data and primary and secondary outcomes are going to be shared after de-identification of the participants.
When the data will become available and for how long
These data files will become available starting 6 months after publication.
To whom data/document is available
The deidentified IPD and additional supporting information/documents will be available for people working in academic institutions.
Under which criteria data/document could be used
None
From where data/document is obtainable
To access the data files applicant can talk to Dr. Shirin Zaresharifi resident of dermatology at Shahid Beheshti University of Medical Sciences.
Address: Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
Postal code: 1985717443
Email address:shirin.zsharifi@sbmu.ac.ir
Phone number: 0098 21 2243 9982
Mobile number: 0098 912 846 5784
What processes are involved for a request to access data/document
The applicants should follow Shahid Beheshti University of Medical Sciences process and protocols for accessing the data files.