Protocol summary

Summary
Cherry angioma is one of the most common cutaneous vascular proliferation, so in this study, we want to compare the efficacy of cryosurgery and electrocoagulation to achieve the most effective treatment option. Patients aged 30 to 60 years without evidence of malignancy were recruited and pregnant or breast-feeding women and patients with history of cold urticaria are excluded. In this study, 50 patients entered the study and underwent electrocoagulation or cryosurgery accidentally at the time of admission,and followed at regular intervals in three months.The outcomes of these two procedures compared and infection, scar, cosmetic outcomes and other side effects were evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012420468N2
Registration date: 2015-06-24, 1394/04/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-24, 1394/04/03
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
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of cryosurgery and electrocoagulation in the treatment of cherry angioma
Public title
Comparison of treatment results of vascular red spots by different procedures
Purpose
Treatment
Inclusion/Exclusion criteria
- Inclusion criteria: Patients with cherry angioma without evidence of malignancy, no evidence of infection in the lesion - Exclusion criteria: Evidence of cold urticaria, cold intolerance, coexistence of cryoglobulinemia or cryofibrinogenemia, pregnancy and lactation, history of keloid, age less than 30 and over 60
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahid Beheshti University of Medical Sciences
Street address
Skin Research Center, Tajrish Square, Shohadaye Tajrish Hospital
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
449,92

Health conditions studied

1

Description of health condition studied
Treatment of patients with cherry angioma.
ICD-10 code
XII
ICD-10 code description
Diseases of the skin and subcutaneous tissue

Primary outcomes

1

Description
The rate of recovery of cherry angioma
Timepoint
Befor procedure,1week,1month, 3 months intevals
Method of measurement
Photography before procedure and in follow up intervals, patient satisfaction

Secondary outcomes

1

Description
Side effects ( pain, infection, scar, dispigmentation, keloid formation)
Timepoint
1 week,1 month,3 months intervals after procedure
Method of measurement
Evaluation of patient photographies by two dermatologists

Intervention groups

1

Description
Intervention group: Electrocoagulation with the same parameters on charry angioma lesions
Category
Treatment - Devices

2

Description
Control Group: Cryotherapy with cotton swap on cherry angioma lesions including two freeze-thaw cycles
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Reza Robati, MD Associate Professor of Dermatology
Street address
Skin Research Center, Shohada-E- Tajrish Educational Hospital, Qods Sq,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parviz Toossi, MD
Street address
Skin Research Center,Shohada-E- Tajrish Educational Hospital,Qods Sq ,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Morteza Ghassemipour
Position
Dermatology Resident
Other areas of specialty/work
Street address
Skin Research Center, Shohada-E- Tajrish Educational Hospital,Qods Sq,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
Dr.ghassemipour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Dr.Reza Robati
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Skin Research Center,Shohada-E- Tajrish Educational Hospital, Qods S ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
rezarobati@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Morteza Ghassemipour
Position
Dermatology Resident
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
Dr.ghassemipour@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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