Seventy female patients with genital warts aged between 15-50 years will included in the study. Exclusion criteria will be topical antiviral drugs in the past two weeks; concurrent sexually transmitted diseases; pregnancy;lactation. Right sided lesions of the patients would be treated by carbon dioxide laser every 3 weeks for 9 weeks. The left sided lesions of the same patients would be treated with 5% KOH solution twice daily for 9 weeks. At each visit clinical data about the therapy and recovery of the patients and side effects will be recorded. Then the patients will be followed up for 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412207848N1
Registration date:2015-01-18, 1393/10/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Ensie Hemmati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 3554
Email address
pazyar.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-02-01, 1392/11/12
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of 5% potassium hydroxide solution versus carbon dioxide laser in the treatment of women genital warts
Public title
Comparison the efficacy of 5% potassium hydroxide solution versus carbon dioxide laser in the treatment of women genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients aged 15-55 years old with multiple genital warts
Exclusion criteria: topical antiviral drugs in the past two weeks; concurrent sexually transmitted diseases; pregnancy;lactation
Age
From 15 years old to 55 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences,Vice Chancellor
City
Shiraz
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2014-07-02, 1393/04/11
Ethics committee reference number
92-01-01-6325
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
Size of genital warts
Timepoint
Before intervention. Every three week from starting of intervention to disappearance of all warts. ُSix months after the end of intervention.
Method of measurement
observational, Ruler
Secondary outcomes
1
Description
Side effects(burning, pain,erythema, ulceration)
Timepoint
Before intervention. Every three week from starting of intervention to disappearance of all warts. Six months after the end of intervention
Method of measurement
observation
Intervention groups
1
Description
Intervention: Topical solution of 5% Potassium hydroxide twice daily for 9 weeks
Category
Treatment - Drugs
2
Description
Control: Carbon dioxide laser every 3 weeks for 9 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ُShiraz University of Medical Sciences, Vice Chancellor
Full name of responsible person
Dr Gholam Reza Hatam
Street address
ُShiraz University of Medical Sciences, Vice Chancellor
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ُShiraz University of Medical Sciences, Vice Chancellor