Protocol summary

Study aim
Determining the effectiveness, safety, tolerability and satisfaction of electrosurgery and cryosurgery in patients with sebaceous hyperplasia, seborrheic keratosis, cherry angioma and skin tag
Design
Clinical trial with two intervention groups, parallel, randomized, phase 2-3 on 128 patients, randomized with sealed envelopes
Settings and conduct
Each lesion is randomly assigned to one of the following two treatment groups: group a: electrosurgery and group b: cryosurgery. For lesions of the first group, electrosurgery is repeated 4 weeks later if necessary and for group b lesions, cryosurgery is repeated 2 and 4 weeks later if necessary. In order to follow up, patients in both groups, 2 weeks, 1 month and also 3 months after the initial session are visited and The data are evaluated by the patient himself, a blind dermatologist and finally the statistical specialist. Also, safety, tolerability and satisfaction of treatments are questioned in follow-up sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirmation of diagnosis with a clinical examination by a dermatologist, age 18 to 70 years Exclusion criteria: For both treatments: infection of the lesion site, history of keloid, pregnancy and lactation, malignancy, immunosuppression For electrosurgery: having an intracardiac device For cryosurgery: cold intolerance, history of Raynaud's phenomenon, vesiculobullous diseases and superficial sensory involvement
Intervention groups
group 1: Electrosurgery group 2: Cryosurgery
Main outcome variables
The rate of improvement, Lesion size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211210053344N1
Registration date: 2021-12-28, 1400/10/07
Registration timing: prospective

Last update: 2021-12-28, 1400/10/07
Update count: 0
Registration date
2021-12-28, 1400/10/07
Registrant information
Name
Mojtaba Shafiei Koohpayeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2390
Email address
shafieikohpayeh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of electrosurgery in comparison with cryosurgery in patients with sebaceous hyperplasia, seborrheic keratosis, cherry angioma and skin tag: A controlled randomized clinical trial
Public title
Comparison of the effect of electrosurgery with cryosurgery in the treatment of sebaceous hyperplasia, seborrheic keratosis, cherry angioma and skin tag
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of diagnosis with a clinical examination by a dermatologist Age 18 to 70 years
Exclusion criteria:
Infection of the lesion site History of keloid Pregnancy and Lactation Malignancy Immunosuppression For electrosurgery: having an intracardiac device For cryosurgery: cold intolerance, history of Raynaud's phenomenon, vesiculobullous diseases and superficial sensory involvement
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
The lesions of the patients are divided into two groups using a simple randomization method, so that out of 32 sealed bags, one bag will be randomly selected for each lesion. Each envelope contains the letter a or b: a for the electrosurgery group and b for the cryosurgery group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of medical scinces
Street address
Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.IUMS.FMD.REC.1400.420

Health conditions studied

1

Description of health condition studied
sebaceous hyperplasia
ICD-10 code
L73.8
ICD-10 code description
Other specified follicular disorders

2

Description of health condition studied
seborrheic keratosis
ICD-10 code
L82
ICD-10 code description
Seborrheic keratosis

3

Description of health condition studied
cherry angioma
ICD-10 code
D18.01
ICD-10 code description
Hemangioma of skin and subcutaneous tissue

4

Description of health condition studied
skin tag
ICD-10 code
L91.8
ICD-10 code description
Other hypertrophic disorders of the skin

Primary outcomes

1

Description
Lesion size
Timepoint
At the beginning of the study, 2 weeks, 1 month and 3 months later
Method of measurement
with a ruler

2

Description
The rate of improvement
Timepoint
2 weeks, 1 month and 3 months after the beginning
Method of measurement
based on evaluation of a blind dermatologist

Secondary outcomes

1

Description
safety
Timepoint
2 weeks, 1 month and 3 months after the beginning
Method of measurement
based on side effects of the treatment (clinical evaluation)

2

Description
tolerability
Timepoint
2 weeks, 1 month and 3 months after the beginning
Method of measurement
based on Investigator Assessment of Tolerability scale

3

Description
satisfaction
Timepoint
2 weeks, 1 month and 3 months after the beginning
Method of measurement
based on Caregiver treatment satisfaction (CTS) questionnaire

Intervention groups

1

Description
Intervention group 1: For patients in this group, electrosurgery is done at the first session and repeated 4 weeks later if necessary (maximum 2 sessions). Electrosurgery is performed with biterminal monopolar electrocoagulation mode and with 20 to 40 degrees, after anesthesia with 0.2 to 0.5 cc of 2% lidocaine.
Category
Treatment - Surgery

2

Description
Intervention group 2: For patients in this group, cryosurgery is done at the first session and repeated 2 and 4 weeks later if necessary (maximum 3 sessions). Cryosurgery is performed using a spray and directly with liquid nitrogen, from a distance of 1 to 2 cm to freeze the entire lesion with a margin of 1 mm. In order to prevent complications, two cycles of cryosurgery are performed for each lesion.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Akram hospital
Full name of responsible person
Afsaneh Sadeghzadeh Bazargan
Street address
Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 6001
Email
afsaneh.sadeghzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghzadeh Bazargan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 7341
Email
afsaneh.sadeghzadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghzadeh Bazargan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 7341
Email
afsaneh.sadeghzadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Shafiei Koohpayeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2390
Fax
Email
shafieikohpayeh.m@iums.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
Not applicable
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