Our purpose in this study is to evaluate the therapeutic effect of formalin 5% solution as an affordable and low-cost treatment on female genital warts.
Design
80 patients with at least 2 similar genital warts are included in the clinical trial with parallel groups in terms of appearance and size. A lesion is treated with 5% formalin solution and the same lesion is treated with cryotherapy. Other lesions are also treated with cryotherapy.
Settings and conduct
The largest diameter of one of the lesions of women with genital warts referring to Dermatology Clinic of Shahid Faghihi Hospital of Shiraz is recorded. 5% formalin solution is applied to the lesion for 10 minutes. This is repeated every day by the patient. The size of the largest diameter of the same lesion is also recorded.The lesion is treated by a physician weekly with cryotherapy. Patients are visited weekly for 4 weeks. The size of the lesions and possible side effects of both treatments are recorded Carefully.
Participants/Inclusion and exclusion criteria
All women with genital warts referring to the dermatology clinic for cryotherapy with at least two or more genital warts of similar appearance and size, in the absence of pregnancy and lactation, immune deficiency, coagulation disorders, other sexually transmitted diseases, or other active skin diseases at the treatment site are included in the study, if they are satisfied.
Intervention groups
One of the lesions is considered as a selective lesion treated with formalin and a lesion of the same size as a selective lesion treated with cryotherapy and as a control group. The size of both lesions and possible side effects are carefully recorded.
Main outcome variables
The rate of reduction in the size of the lesions and the overall recovery are compared in both treatments. Complications of both treatments are recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190714044200N1
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Amir Miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9049
Email address
miria@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of 5% formalin in treatment of female genital warts comparing to cryotherapy
Public title
The effect of formalin on treatment of genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All female patients with external genital warts referred for treatment with cryotherapy
Patients should have at least 2 genital warts of the same size and appearance.
Exclusion criteria:
A wound or active skin disease other than wart at the treatment site
Coagulation disorder
The presence of other sexually transmitted diseases
Immunodeficiency, such as HIV infection
Using topical anti viral medications in the last two weeks
Pregnancy and lactation
Lesions in the internal genital system, such as vagina and cervix
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
2
Each lesion is independently considered as a sample. One of the lesions is considered as a selective lesion for treating with formalin and a lesion of the same size as a selective lesion undergoing cryotherapy
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients with genital warts who have two or more lesions are included in the study, and each lesion is independently considered as a sample. One of the lesions is considered as a selective lesion for treating with formalin and a lesion of the same size as a selective lesion undergoing cryotherapy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
IR.SUMS.REC.1395.S171
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
measurement of genital wart size in female patients
Timepoint
At the beginning of the study, one week later, two weeks later, three weeks later, four weeks after starting treatment
Method of measurement
caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient uses the 5% formalin solution in the collodion base provided by the hospital pharmacist on the genital warts topically by an applicator daily for 10 minutes.
Category
Treatment - Drugs
2
Description
Control group: Cryotherapy of genital warts is done weekly by a dermatologist. The device manufactured by the company Iran Sarma darman is used and The chemical substance used in this method is a liquid nitrogen with temperature of -198. Each cryotherapy session is performed for two 20-second freezing cycles and a 60 second thawing cycle.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic, Shahid Faghih Hospital of Shiraz University of Medical Sciences
Full name of responsible person
Amir Miri
Street address
Zand Blvd, Shahid Faghihi Hospital, Dermatology Department office
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Fax
+98 71 3233 1634
Email
miria@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand Blvd
City
Shiraz
Province
Fars
Postal code
3478671946
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Razeghi
Position
Resident of obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3225 2618
Email
r_mahsa_2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahia Namavar Jahromi
Position
professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3233 2365
Email
namavarb@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahia Namavar Jahromi
Position
professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3233 2365
Email
namavarb@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information and data from the research: Information on the main outcome
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Information on the main outcome in the form of correspondence with researchers
From where data/document is obtainable
OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
After applying to the office of the Department of OB And GYN of Shiraz University of Medical Sciences, this request is sent to the university's vice chancellor. If the information is agreed upon, it is provided to the applicant. The approximate duration of this process is one week.