Protocol summary

Summary
In this trial efficacy of cryotherapy and CO2 laser in the treatment of plantar wart is compared. Sixty patients with plantar wart who were visited at dermatology clinic of Shahid Faghihi Hospital is included and will be allocated into two groups of 30 members according to block randomization. Inclusion criteria are plantar warts patients above 18 years old who take no treatment yet. Exclusion criteria are pregnancy, lactation and history of keloid formation. Both groups underwent treatment weekly and response as the size of warts will be recorded with photography and caliper. In cryotherapy group, each session has two 15-seconds cycles. Treatment failure in cryotherapy group is defined as 12 sessions without clearance of warts. The other group underwent LASER therapy with continuous mode, power of 15-25 watt and 1-2 passes. Failure of treatment defined as the presence of the lesion after 3 sessions. The research is single blinded (for the analyzer).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052831028N2
Registration date: 2017-07-24, 1396/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
Seyed Mohammad Salar Zaheryani
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 1510
Email address
smszaheryany@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of carbon dioxide laser and cryotherapy in plantar wart
Public title
effectiveness difference between cryotherapy and carbon dioxide laser in treatment of plantar warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with plantar wart that were above 18 year old; did not take any treatment for their plantar warts yet exclusion criteria: pregnancy; lactation; history of keloid formation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.SUMS.MED.REC.1396.08

Health conditions studied

1

Description of health condition studied
plantar wart
ICD-10 code
B07
ICD-10 code description
Viral warts

Primary outcomes

1

Description
area affected with wart
Timepoint
before starting of treatment and then weekly up to 12 week
Method of measurement
photography and use Caliper

Secondary outcomes

empty

Intervention groups

1

Description
Control group: cryotherapy was done weekly until cure of wart or 12 sessions of treatment were done. in each session 2 cycle of 15 seconds treatment are done .
Category
Treatment - Surgery

2

Description
Intervention group: patients were treated with continuous mode of CO2 laser ,15-25 watt and 1-2 pass weekly . treatment was done until clearance of warts or 3 sessions.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faghihi Hospital of Shiraz
Full name of responsible person
Nahid Hemmatian Boroujeni
Street address
Dermatology Department,Shahid Faghihi Hospital, Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Masoom Masoompour
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nahid Hemmatian Boroujeni
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Shahid Faghihi Hospital
City
Shiraz
Postal code
Phone
+98 71 3231 9049
Fax
Email
n_hemmatian_b@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nahid Hemmatian Boroujeni
Position
Resident of dermatology
Other areas of specialty/work
Street address
Shahid Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 3231 9049
Fax
Email
n_hemmatian_b@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Nahid Hemmatian Boroujeni
Position
Resident of dermatology
Other areas of specialty/work
Street address
Dermatology Department,Shahid Faghihi Hospital, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3231 9049
Fax
Email
n_hemmatian_b@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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