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Efficacy and safety of combined carboxytherapy and 50% topical urea cream in the treatment of common warts

Protocol summary

Study aim
efficacy and safety of combined carboxytherapy and 50% topical urea cream in the treatment of common warts
Design
parallel-group randomized trial, one-sided blind, design of 20 patients, Intervention and control groups in each person are randomly selected by a simple coin toss
Settings and conduct
Valieasr hospital, Arak, Iran, Carboxytherapy is performed by the supervisor on the intervention side, topical urea is used by the patient on both sides. The lesions of the control group will be shaved by the project manager on a weekly basis, and the clinic nurse who counts the number of warts on the left and right hands of each person does not know which hand is the intervention and which is the control.
Participants/Inclusion and exclusion criteria
Age more than 18 years, The presence of more than six recurrent common warts in one of the upper or lower limbs, Distribution of lesions on both right and left sides, At least 3 lesions on each side, Absence of pregnancy and breastfeeding, Not to suffer from systemic diseases such as diabetes, kidney diseases, heart diseases, respiratory diseases, liver diseases, anemia, etc. Not having connective tissue diseases or genodermatosis,
Intervention groups
In this study, there is one side of the intervention group and one side of the control group for each patient. For both sides, 50% urea topical medication is prescribed as routine treatment, and carboxytherapy (intervention) will also be performed on one side.
Main outcome variables
number of warts; skin scar; pain at the treatment site; Pigmentation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240413061476N1
Registration date: 2024-07-08, 1403/04/18
Registration timing: registered_while_recruiting

Last update: 2024-07-08, 1403/04/18
Update count: 0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
zahra rafie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3563
Email address
zahrarafie7609@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-04, 1403/04/14
Expected recruitment end date
2024-10-05, 1403/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of combined carboxytherapy and 50% topical urea cream in the treatment of common warts
Public title
Efficacy of carboxytherapy in the treatment of wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study Age greater than18 Both genders The presence of more than six recurrent common warts in one of the upper or lower limbs Distribution of lesions on both right and left sides At least 3 lesions on each side
Exclusion criteria:
Absence of pregnancy and breastfeeding No smoking, alcohol, and drug abuse Not to suffer from systemic diseases such as diabetes, kidney diseases, heart diseases, respiratory diseases, liver diseases, anemia, etc. Not having connective tissue diseases or genodermatosis
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The coin toss and flip method is used to determine the side of intervention. In this method, we consider the back of the coin as the right hand and the face of the coin as the left hand. And the opposite hand will be the side of the witness
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is one-way blind. For blinding, the clinic nurse who counts the number of warts on each person's left and right hands does not know which hand is the intervention and which is the control.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of َArak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.ARAKMU.REC.1402.074

Health conditions studied

1

Description of health condition studied
Common wart
ICD-10 code
B07.9
ICD-10 code description
Viral wart, unspecified

Primary outcomes

1

Description
Number of warts
Timepoint
At the beginning of the study (before the start of the intervention), and before each session (sessions 2, 3, 4, and 5), and two weeks after the last session
Method of measurement
Eye and digital camera

Secondary outcomes

1

Description
Skin scar
Timepoint
Before each session and two weeks after the last session
Method of measurement
Digital camera

2

Description
Pain at the treatment site
Timepoint
After each session
Method of measurement
Visual Analogue Scale

3

Description
Pigmentation
Timepoint
Before each session and two weeks after the last session
Method of measurement
Digital camera

Intervention groups

1

Description
Intervention group: carboxytherapy by injecting 2cc of carbon dioxide gas by MEDAION carboxytherapy device, made in Iran, Nik Fanavaran Plasma company subcutaneously for each wart lesion weekly for 5 weeks along with the consumption of 50% urea (made by an Iranian company named Sepidaj) in the basis of Osrin (manufactured by Iranian company named Emad) as a routine treatment
Category
Treatment - Drugs

2

Description
Control group: consumption of urea 50% (manufactured by Iranian company Sepidaj) in the base of Osrin (manufactured by Iranian company Emad) as a routine treatment twice a day on warts
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Nooshin Bagherani
Street address
Valiasr hospital, Valiasr Sq., Imam khomeini Ave.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpoo
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Rafie
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arak University of Medical Sciences, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
zahrarafie7609@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nooshin bagherani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Arak University of Medical Siences, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
nooshinbagherani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Rafie
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arak University of Medical Siences, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
zahrarafie7609@gmail.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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