Protocol summary

Summary
Objectives:To compare the efficacy of 5 FU vs. cryotherapy in the treatment of the backhand wart Design: Clinical trial study Setting and conduct: Randomized clinical trial study Participants including major eligibility criteria: Sixty patients with backhand wart were evaluated Intervention: The case group were treated with 5 FU for four hours twice a day for four weeks and the control group were treated with cryotherapy twice with two week interval. Main outcome: The patients were evaluated in regard of improvment, side effects and recurrance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310185605N3
Registration date: 2013-11-26, 1392/09/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-26, 1392/09/05
Registrant information
Name
MOHAMAD GOLDUST
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133614711
Email address
medres@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2012-03-21, 1391/01/02
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison study of 5 FU vs. cryotherapy in the treatment of the backhand wart
Public title
The comparison study of 5 FU vs. cryotherapy in the treatment of the backhand wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Sixty patients with backhand wart were evaluated Exclusion criteria: Pregnant and lactating women; Patients with Raynaud's syndrome, Patients with collagen vascular disease; Patients who eceived wart treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethic committee of Tabriz university of medical sciences
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
91108

Health conditions studied

1

Description of health condition studied
Wart
ICD-10 code
B07
ICD-10 code description
Wart

Primary outcomes

1

Description
Improvment
Timepoint
4 weeks
Method of measurement
Clinical assesment

Secondary outcomes

empty

Intervention groups

1

Description
The case group were treated with 5 FU for four hours twice a day for four weeks
Category
Treatment - Drugs

2

Description
The control group were treated with cryotherapy twice with two week interval.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of dermatology, Sina hospital
Full name of responsible person
Dr Hamideh Herizchi Qadim
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Ali Meshkini
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Dr Rahim Asghari Azar
Position
Resident in Dermatology
Other areas of specialty/work
Street address
5166614711, Azadi street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
dr.asghariazar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Hamideh Herizchi Qadim
Position
Assistant professor in dermatology
Other areas of specialty/work
Street address
5166614711, Azadi street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
Drherizchi@yahoo.com
Web page address

Person responsible for updating data

Contact

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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