Comparison of the local effect of 5%KOH solution with cryotherapy in the treatment of patients with genital warts
Design
A clinical trial study investigating the effect of 5% KOH solution compared to cryotherapy as a control group will be conducted on 98 patients (49 people in the intervention group and 49 people in the control group) and for randomization the blocking method will be used
Settings and conduct
This study will be conducted in the dermatology clinic of Imam Reza Hospital in Mashhad.The selected patients were randomly divided into two groups, and the first group included 49 patients treated with 5% KOH solution daily locally using a swap, and the second group included 49 patients treated with cryotherapy.Patients will be visited before starting the treatment and their age, sex, number of lesions will be checked and recorded.Then, patients are visited at intervals of 4 weeks from the beginning of treatment to 12 weeks, and the number of lesions, duration of complete recovery (based on days) and skin complications including itching and pain (using a score of 1 to 10) and Hyperpigmentation or hypopigmentation, erosion and ulcers (occurrence or absence of complications) will be checked and recorded. 8 weeks after complete recovery, patients will be visited for recurrence.
Participants/Inclusion and exclusion criteria
Entry condition: patients with external genital warts whose number of lesions is less than 10 and the size of lesions is less than 1 cm.
Conditions of non-entry: pregnant and lactating women, age less than three years, sensitivity to potassium hydroxide solution, warts larger than 1 cm or more than 10
Intervention groups
Daily treatment with 5% KOH solution locally
Main outcome variables
Number of scraps
Time to complete recovery
Skin complications including itching, pain, hyper or hypopigmentation, erosion and ulcers
Recurrence of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230417057941N1
Registration date:2023-05-24, 1402/03/03
Registration timing:registered_while_recruiting
Last update:2023-05-24, 1402/03/03
Update count:0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Fateme Javame Ghazvini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 8073
Email address
javamef991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the topical effect of 5% potassium hydroxide solution with cryotherapy in the treatment of patients with genital warts
Public title
Comparison of the topical effect of 5% potassium hydroxide solution with cryotherapy in the treatment of patients with genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with external genital warts whose number of lesions is less than 10 and the size of lesions is less than 1 cm
Exclusion criteria:
Age
From 3 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a block method with sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Considering that the treatment methods of the intervention group and the control group are completely different, therefore, only the researchers and the outcome evaluators and the analyzers can be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences-Educational, Research and Treatment Cente
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177154088
Approval date
2022-12-19, 1401/09/28
Ethics committee reference number
IR.MUMS.IRH.REC.1401.040
Health conditions studied
1
Description of health condition studied
Genital wart
ICD-10 code
A63.0
ICD-10 code description
Other predominantly sexually transmitted diseases, not elsewhere classifiedExcl.:molluscum contagiosum (B08.1)papilloma of cervix (D26.0)A63.0Anogenital (venereal) wartsA63.8Other specified predominantly sexually transmitted diseases
Primary outcomes
1
Description
Response to treatment: The ratio of the number of fully treated patients divided by the total number of patients in that group multiplied by 100
Timepoint
before starting treatment and at four-week intervals for a maximum of 12 weeks
Method of measurement
کاهش تعداد ضایعات به وسیله مشاهده محققReducing the number of wastes by observing the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Treatment with 5% KOH solution, prepared by a pharmacist colleague in the Faculty of Pharmacy, is applied topically on the wart lesions using a swab by the patient until the lesions heal (for a maximum of 12 weeks)
Category
Treatment - Drugs
2
Description
Control group:Treatment with cryotherapy (liquid nitrogen) with 5-20 cycles every 2 weeks is performed by the doctor until the lesions heal (for a maximum of 12 weeks).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Fateme Javame
Street address
Dermatology clinic of Imam Reza hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177154088
Phone
+98 51 3879 8073
Email
Javamef991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour
Street address
Danesh va salamat town , Fakoori Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177154088
Phone
+98 51 3879 8073
Email
Javamef991@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatame Javame
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 72 , Forghani 15 , Piroozi 26
City
Mashhad
Province
Razavi Khorasan
Postal code
9177154088
Phone
+98 51 3879 8073
Email
Javamef991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatame Javame
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 72 , Forghani 15 , Piroozi 26
City
Mashhad
Province
Razavi Khorasan
Postal code
9177154088
Phone
+98 51 3879 8073
Email
Javamef991@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatame Javame
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 72 , Forghani 15 , Piroozi 26
City
Mashhad
Province
Razavi Khorasan
Postal code
9177154088
Phone
+98 51 3879 8073
Email
Javamef991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
since 2024
To whom data/document is available
Medical and health researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
To the researchers of this research
What processes are involved for a request to access data/document