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Comparison of the effect of cryotherapy and Podophyllin solution 25% for treatment of genital warts in women

Protocol summary

Summary
the aim of this study that is randomized clinical trial,is to determined and compare the effectivness and adverse effects of the most common treatments of the genital warts, podophyllin solotion 25% and cryotherapy. external genital warts cases who referred to the Khatam Alanbia polyclinic in yazd, are enrolled and randomaly divided in to two groups after considering inclusion and exclusion criteria. in the first group, liquid nitrogen is used for cryotherapy, using an applicator to apply it on the lesion. duration of cryotherapy is until the entire lesion and a millimeter of this become white, each method is applied once for any lesion. In the second group podophyllin solution 25% is applied with an applicator on lesion. before using the drug the surrounding of the lesion is coated with zinc oxide cream. patients were advised to wash the place after 4 hours. at baseline, information about the patient such as age, duration of disease, peaceful or disturbed matrimonial relation,and physical exam findings, such as the place and the number of lesion will be collected. patients are treated on a weekly basis until full recovery from lesion for 6 weeks and at every appointment, the number of lesions and possible side effects are recorded. the primary outcome is the improvment of genital warts including full removal of lesion and partial recovery of lesion, which is more than 75%,respectively.if the recovery is less than 75% during the treatment period of 6 week, no improvement or treatment failure will be considered.secondry outcome is side effects leading to complications including pain, irritation and ulcer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090514386N1
Registration date: 2015-09-05, 1394/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-05, 1394/06/14
Registrant information
Name
Maryam Sadat Torabipour
Name of organization / entity
Shahid Sadooghi University of Medical Sciences,Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 2960
Email address
maryamtorabipour@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadooghi University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cryotherapy and Podophyllin solution 25% for treatment of genital warts in women
Public title
Comparison of the effectiveness of two common treatments for genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the existence of external genital warts in the genital area; the existence of external genital warts in the anus; female patients. Exclusion criteria: age under 15 years; pregnancy; lactation
Age
From 15 years old
Gender
Female
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)
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 Sadooghi University of Medical Sciences,Yazd
Street address
Central Office of Shahid Sadooghi University of Medical Sciences, Shahid Sadooghi blvd,Yazd
City
Yazd
Postal code
Approval date
2014-05-22, 1393/03/01
Ethics committee reference number
ir.ssu.medicine.rec.1393.3

Health conditions studied

1

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

Primary outcomes

1

Description
Improvement of genital warts
Timepoint
The beginning of the study, the first week,the second week, the third week,the fourth week, the fifth week, the sixth week.
Method of measurement
Observation, physical examination

Secondary outcomes

1

Description
Side effect (burn)
Timepoint
The beginning of the study, the first week,the second week,the third week,the fourth week,the fifth week,the sixth week.
Method of measurement
Observation, physical examination

2

Description
Side effect (Swelling)
Timepoint
The beginning of the study, the first week,the second week,the third week,the fourth week,the fifth week,the sixth week.
Method of measurement
Observation, physical examination

3

Description
Side effect (pain)
Timepoint
The beginning of the study, the first week,the second week,the third week,the fourth week,the fifth week,the sixth week.
Method of measurement
Observation, physical examination

Intervention groups

1

Description
In the first group liquid nitrogen is applied on the lesion for cryotherapy and By using applicator is applied on waste. duration of cryotherapy is until the Whitening of the entire lesion and one millimeter from its border which is applied once for any lesion.
Category
Treatment - Surgery

2

Description
In the second group Podophyllin solution 25% is applied on lesion using an applicator. Before using the drug,the surrounding of the lesion around the lesion is coated with Zinc Oxide Cream. Patients are advised to completely wash place after 4 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatamolanbia Specialty and Subspecialty Poly Clinic
Full name of responsible person
Maryam Sadat Torabipour
Street address
Taleghani blvd, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Amir Hushang Mehrparvar, MD
Street address
Central office of Shahid Sadooghi University of Medical Sciences, Shahid Sadooghi blvd,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadooghi University of Medical Sciences,Yazd
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
Shahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Maryam Sadat Torabipour
Position
student
Other areas of specialty/work
Street address
Central office of Shahid Sadooghi University of Medical Sciences, Shahid Sadooghi blvd,Yazd
City
yazd
Postal code
8915674948
Phone
+98 35 3724 9333
Fax
+98 35 1525 5406
Email
maryamtorabipour@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Dr. Parichehr Kafaei
Position
Assistant professor of dermatology
Other areas of specialty/work
Street address
Burn and Accident Hospital, Paknejad blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3525 0093
Fax
+98 35 1525 5406
Email
p.kafaie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences, Yazd
Full name of responsible person
Maryam Sadat Torabipour
Position
Student
Other areas of specialty/work
Street address
Central office of Shahid Sadooghi University of Medical Sciences, Shahid Sadooghi blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3525 0093
Fax
+98 35 1525 5406
Email
maryamtorabipour@ssu.ac.ir
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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