Protocol summary

Study aim
Comparison of the effectiveness of 5-fluorouracil ointment 5% and calcipotriol ointment 50 micrograms in the treatment of genital warts
Design
A clinical trial without a control group, community-based and practice-oriented, parallel groups, double-blind, randomized, phase 2 on 60 patients (30 people receiving 5-fluorouracil 5% and 30 people receiving calcipotriol 50 micrograms) . A simple randomization method was used for randomization.
Settings and conduct
To investigate the effectiveness of 5% 5-fluorouracil ointment in genital warts and compare its effect with calcipotriol 50 micrograms, patients diagnosed with genital warts who refer to the skin clinic of Imam Khomeini Hospital, Ahvaz, are randomly divided into two groups. The first group will receive 5% 5-fluorouracil ointment and the second group will receive 50 micrograms of calcipotriol. Then, after 1 month of treatment, the effect of the drug is measured through a clinical examination. Also, the study is conducted in a double-blind manner (patient and interventionist) so that the medicine in the same container will be given to the patients by a non-interventionist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are diagnosed with genital warts for the first time or who have not received genital warts treatment in the last three months, and do not have any other skin disease. Exclusion criteria: patients with immune system dysfunction, with a previous history of allergy to the study drugs, and pregnant and lactating women.
Intervention groups
Receiving 5% 5-fluorouracil ointment (n=30) and calcipotriol ointment 50 micrograms (n=30) three times a week for one month
Main outcome variables
The location and size of the lesion, and the number of genital warts

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230913059421N1
Registration date: 2023-10-01, 1402/07/09
Registration timing: prospective

Last update: 2023-10-01, 1402/07/09
Update count: 0
Registration date
2023-10-01, 1402/07/09
Registrant information
Name
Ahmadreza Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 601 7804
Email address
zamani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of 5% 5-fluorouracil ointment and 50 microgram calcipotriol ointment in the treatment of genital warts
Public title
Effectiveness of 5% fluorouracil ointment in the treatment of genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed with genital warts for the first time or who have not received treatment for genital warts in the last three months. Do not have any other skin disease
Exclusion criteria:
Patients with immune system dysfunction Having a previous history of allergy to the studied drugs Pregnant and lactating women
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two intervention groups using randomized block method. For this purpose, blocks of four are prepared, the name of the intervention is written on two sheets and the name of the comparison is written on the other two sheets. The sheets are piled up and placed in the container, and one sheet is pulled out for each patient without placing it. Then four sheets are returned to the container and this process is repeated until the sample volume is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be evaluated by another specialist as part of the main research, and the design will be done in a double-blind manner. Medicines are provided to patients in a sealed container which is the same for two groups by a person who does not participate in this study and the patients will not know about its contents due to the similarity of the two types of medicine.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur Ahvaz University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1402.044

Health conditions studied

1

Description of health condition studied
Genital wart
ICD-10 code
B07
ICD-10 code description
Viral warts

Primary outcomes

1

Description
location of the lesion
Timepoint
Before treatment, 1 and 3 months after treatment
Method of measurement
Physical examination

2

Description
The size of the lesion
Timepoint
Before treatment, 1 and 3 months after treatment
Method of measurement
Physical examination

3

Description
Number of genital warts
Timepoint
Before treatment, 1 and 3 months after treatment
Method of measurement
Physical examination

Secondary outcomes

1

Description
Recurrence of the disease
Timepoint
Before treatment, 1 and 3 months after treatment
Method of measurement
Physical examination

2

Description
Side effects
Timepoint
1 and 3 months after treatment
Method of measurement
Physical examination

Intervention groups

1

Description
Intervention group: Recipient of topical 5-FU 5% ointment (Efudex Co) three times a week (n=30) for one month
Category
Treatment - Other

2

Description
Intervention group: Receiving topical calcipotriol ointment (Tehran Chemie Pharmaceutical Co) twice a day (n=30) for one month
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Khomeini Hospital
Full name of responsible person
Ahmadreza Zmani
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3311 0000
Email
zamani.a@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmadreza Zamani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 916 601 7804
Fax
Email
zamani.a@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmadreza Zamani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 916 601 7804
Fax
Email
zamani.a@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmadreza Zamani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 916 601 7804
Fax
Email
zamani.a@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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