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Efficacy and safety of nd:yag laser therapy with cryotherapy in extremities(hand,foot) wart

Protocol summary

Summary
The main goal of this study is analyzing the effect of ND YAG laser as an effective alternative method and accessible choice for treatment of extremities wart. This study is based on clinical trial. Inclusion criteria: Bilateral warts on extremities (hand ,foot) Exclusion criteria: Immunodeficiency state, immunomodulator drug usage during 4 weeks past, history of antiviral agent during 2 weeks past, pregnancy, breast feeding. Design: randomized, double blinded, parallel, phase1 clinical trial. Methodology: Targets are selected among the Patients referring to Shohada-e-Tajrish Educational Hospital. target sample size is 63 which has been selected from our outpatient clinic. Implantation method: The patients with bilateral extremities’ warts are the targets of this study ,and all of their demographics datas and properties(site ,diameter) of warts and association are saved. After preparation and anesthesia one side treat with Cryotherapy with liquid nitrogen, and another side treat with nd:yag laser. The diameter of each lesion is measured and the evaluated both before each treatment session and 3months after the last one with digital photography and ruler as well and the assessment of side effects (eg., pain, stinging, pruritus, redness, bulla , bleeding, crust formation, hypopigmentation, hyperpigmentation, scar, atrophy)is performed. Index of treatment is according to average and standard deviation which is deviation the number of treated lesion into the number of total lesions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050127707N1
Registration date: 2016-08-16, 1395/05/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-16, 1395/05/26
Registrant information
Name
Behzad Iranmanesh
Name of organization / entity
Shahid Behshti Medical University,Skin Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 1435
Email address
mgheisari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin Research Center of Shahid Beheshti Medical University.
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of nd:yag laser therapy with cryotherapy in extremities(hand,foot) wart
Public title
Efficacy of laser therapy in extrimity wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:bilateral warts on extremities(upper or lower) Exclusion criteria:immunodeficiency state(diabetes mellitus;alcohol abuse) congenital immunodeficiency disorders; hematologic malignancy; drug history of immunnomodulator agent during 4 weeks past; drug history of anti viral agent during 2 weeks past;pregnancy;breast feeding.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 63
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
shahid beheshti medical univwersity
Street address
chamran high way,yaman sreet,arabi sreet
City
tehran
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.SBMU.RAM.REC.1394.419

Health conditions studied

1

Description of health condition studied
wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts

Primary outcomes

1

Description
diameter of primary lesion on centimeters
Timepoint
2weeks
Method of measurement
ruller

Secondary outcomes

1

Description
blister and ulser formation
Timepoint
2 weeks
Method of measurement
physical examination

Intervention groups

1

Description
The patients with bilateral extrimitie's warts will join to study,and all of their demoghraphic datas and properties(site,diameter) of warts and association are saved . after preparation and anesthesia one side treat with long pulsed nd;yag laser(laser optek) with setting , fluence: 200 j/cm^2 , spot size :3mm, duration:20ms، wave length: 1064 nm. in every session with 3 shots circular guide. all patients follow and evaluate 3 months after the last session, index of treatment is treated lesion devided into tatol lesions.
Category
Other

2

Description
The patients with bilateral extrimitie's warts will join to study,and all of their demoghraphic datas and properties(site,diameter) of warts and association are saved . after preparation and anesthesia one side treat with cryo therapy with liquid nitrogen -196cellsius and 2mm margin with open spray every 2 weeks bye 3 times.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada e Tajrish
Full name of responsible person
Dr.Mehdi Gheisari-Assistant 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
Shahid Beheshti University of Medical Science-Skin Research Center.
Full name of responsible person
Dr Parviz Toosi
Street address
Iran, Tehran, Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran, Islamic Republic Of
City
Tehran
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 Science-Skin Research Center.
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
Behzad Iranmanesh
Position
Assistant Resident of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center), Shohada-E- Tajrish Educational Hospital, Qods Sq., Tehran, Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 2676 1435
Fax
Email
behzad_ariiana@yahoo.com mgheisari@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Dr.Mehdi Gheisari
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Skin Research Center, Shohada-E- Tajrish Educational Hospital, Qods Sq. ,Tehran, Iran Tehran
City
Tehran
Postal code
Phone
+98 913 151 9705
Fax
Email
mgheisari@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Behzad Iranmanesh
Position
Assistant Resident of Dermatology
Other areas of specialty/work
Street address
Skin Research Center, Shohada-E- Tajrish Educational Hospital, Qods Sq. ,Tehran, Iran Tehran
City
Tehran
Postal code
Phone
+98 21 2676 1435
Fax
Email
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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