Protocol summary

Summary
Objective: Comparison of efficacy and side effects of topical 15% potassium hydroxide solution and cryotherapy in treatment of common wart Design: Non- randomized; non- blinding Inclusion criteria: common wart with a diameter less than 5mm ; on the hands or feet bilaterally Exclusion criteria: pregnancy; lactation; treatment during one recent month; secondary skin infection

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081118765N1
Registration date: 2014-12-12, 1393/09/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-12, 1393/09/21
Registrant information
Name
Salah shohani
Name of organization / entity
jundishapur scientific medical university of ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7543
Email address
shohani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and side effects of topical 15% potassium hydroxide solution and cryotherapy in the treatment of common wart.
Public title
Treatment of common warts with topical solution of potassium hydroxide 15%
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient who have common wart with diameter less than 5 mm, on the hand or foot bilaterally. Exclusion criteria: pregnancy; lactation; treatment during one recent month; secondary skin infection
Age
From 3 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 29
Randomization (investigator's opinion)
Not 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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
672/D

Health conditions studied

1

Description of health condition studied
Common wart
ICD-10 code
I-B07
ICD-10 code description
Verruca Vulgaris

Primary outcomes

1

Description
Reduced size of Common warts
Timepoint
Before intervention. Every week from starting of intervention to disappearance of all warts. Two months after the end of intervention.
Method of measurement
observation; Ruler

Secondary outcomes

1

Description
Side effects
Timepoint
Before intervention. Every week from starting of intervention to disappearance of all warts. Two months after the end of intervention
Method of measurement
observation

Intervention groups

1

Description
Intervention group: Drug: Topical solution of 15% Potassium hydroxide Direct education to patients. Period of application: Disappearance of warts Application: Cotton swap weltering in solution of KOH 15% then put on each wart for 20 seconds, twice a day.
Category
Treatment - Drugs

2

Description
Control group :Treatment with cryotherapy Application: One cotton swap be drowned in to nitrogen liquid then put on each wart for ten seconds and repeat it twice.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic of Ahvaz Imam Hospital
Full name of responsible person
Salah Shohani resident of Dermatology
Street address
Dermatology Clinic, Azadegan street, Imam Hospital, Ahvaz,Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor
Full name of responsible person
Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Salah Shohani
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology Clinc, Imam Hospital, Azadegan Street, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
shohani.s@ajums.acir
Web page address
Imam Hospital .com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Salah Shohani
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology Clinic, Imam Hospital, Azadegan Street, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
shohani.s@ajums.acir
Web page address
Imam Hospital .com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Salah Shohani
Position
Resident of dermatology
Other areas of specialty/work
Street address
Dermatology Clinic, Imam Hospital Azadegan Street, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
shohani.s@ajums.acir
Web page address
Imam Hospital .com

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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