Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Inclusion criteria:
Patients with cutaneous warts that are diagnosed by a dermatologist clinically or pathologically and need treatment.
- Over 2 years old
- Informed consent to enter the study
-The number of warts up to 20
Exclusion criteria:
- Children under 2 years, pregnant and lactating women
- Patients who are contraindicated for calcipotriol treatment.
- Facial warts
- Patients who do not consent to participate in the study.
- People who are allergic to topical vitamin D derivatives.
-Widespread warts that need further treatment.
Inclusion criteria:
Patients with cutaneous warts that are diagnosed by a dermatologist clinically or pathologically and need treatment.
- Over 4 years old
- Informed consent to enter the study
-The number of warts up to 20
Exclusion criteria:
- Children under 2 years, pregnant and lactating women
- Patients who are contraindicated for calcipotriol treatment.
- Facial genital warts
- Patients who do not consent to participate in the study.
- People who are allergic to topical vitamin D derivatives.
-Widespread warts that need further treatment.
Inclusion criteria: Patients with cutaneous warts that are diagnosed by a dermatologist clinically or pathologically and need treatment. - Over 24 years old - Informed consent to enter the study -The number of warts up to 20 Exclusion criteria: - Children under 2 years, pregnant and lactating women - Patients who are contraindicated for calcipotriol treatment. - Facial genital warts - Patients who do not consent to participate in the study. - People who are allergic to topical vitamin D derivatives. -Widespread warts that need further treatment.
معیارهای ورود به مطالعه:
- بیماران مبتلا به وارت پوستی که توسط درماتولوژیست بصورت بالینی یا پاتولوژیک تشخیص داده شده و نیاز به درمان دارند.
- سن بالای 2 سال
-رضایت اگاهانه جهت ورود به مطالعه از افراد بالغ و در غیر این صورت از ولی بیمار به صورت کتبی
-تعداد زگیل ها حداکثر تا 20 عدد
معیارهای خروج :
-اطفال زیر 2 سال، زنان باردار و شیرده
-بیمارانی که برای انجام درمان با کلسیپوتریول کنترااندیکاسیون دارند.
-وارت های صورت
-بیمارانی که رضایت شرکت در مطالعه را نمیدهند.
-افرادی که به مشتقات ویتامین دی موضعی حساسیت دارند.
- زگیلهای منتشری که به درمان دیگری هم نیاز داشته باشند.
معیارهای ورود به مطالعه:
- بیماران مبتلا به وارت پوستی که توسط درماتولوژیست بصورت بالینی یا پاتولوژیک تشخیص داده شده و نیاز به درمان دارند.
- سن بالای 4 سال
-رضایت اگاهانه جهت ورود به مطالعه از افراد بالغ و در غیر این صورت از ولی بیمار به صورت کتبی
-تعداد زگیل ها حداکثر تا 20 عدد
معیارهای خروج :
-اطفال زیر 2 سال، زنان باردار و شیرده
-بیمارانی که برای انجام درمان با کلسیپوتریول کنترااندیکاسیون دارند.
-وارت های صورت و ژنیتال
-بیمارانی که رضایت شرکت در مطالعه را نمیدهند.
-افرادی که به مشتقات ویتامین دی موضعی حساسیت دارند.
- زگیلهای منتشری که به درمان دیگری هم نیاز داشته باشند.
معیارهای ورود به مطالعه: - بیماران مبتلا به وارت پوستی که توسط درماتولوژیست بصورت بالینی یا پاتولوژیک تشخیص داده شده و نیاز به درمان دارند. - سن بالای 24 سال -رضایت اگاهانه جهت ورود به مطالعه از افراد بالغ و در غیر این صورت از ولی بیمار به صورت کتبی -تعداد زگیل ها حداکثر تا 20 عدد معیارهای خروج : -اطفال زیر 2 سال، زنان باردار و شیرده -بیمارانی که برای انجام درمان با کلسیپوتریول کنترااندیکاسیون دارند. -وارت های صورت و ژنیتال -بیمارانی که رضایت شرکت در مطالعه را نمیدهند. -افرادی که به مشتقات ویتامین دی موضعی حساسیت دارند. - زگیلهای منتشری که به درمان دیگری هم نیاز داشته باشند.
Intervention group: 0.05% calcitriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions so that the ointment with a thickness of one millimetre is applied on the lesion surface.
Control group: Only receive routine treatment.
Intervention group: 0.005% calcitriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions so that the ointment with a thickness of one millimetre is applied on the lesion surface.
Control group: Only receive routine treatment.
Intervention group: 0.050.005% calcitriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions so that the ointment with a thickness of one millimetre is applied on the lesion surface. Control group: Only receive routine treatment.
گروه مداخله : پماد کلسی پوتریول 0/05% علاوه بر درمان روتین به صورت دوبار در روز (هر 12 ساعت) توسط خود فرد یا والدین بیمار بر روی ضایعات استعمال می شود، به طوریکه پماد با ضخامت یک میلی متر روی سطح ضایعه را بپوشاند.
گروه کنترل : تنها تحت درمان روتین قرار میگیرند.
گروه مداخله : پماد کلسی پوتریول 0/005% علاوه بر درمان روتین به صورت دوبار در روز (هر 12 ساعت) توسط خود فرد یا والدین بیمار بر روی ضایعات استعمال می شود، به طوریکه پماد با ضخامت یک میلی متر روی سطح ضایعه را بپوشاند.
گروه کنترل : تنها تحت درمان روتین قرار میگیرند.
گروه مداخله : پماد کلسی پوتریول 0/05005% علاوه بر درمان روتین به صورت دوبار در روز (هر 12 ساعت) توسط خود فرد یا والدین بیمار بر روی ضایعات استعمال می شود، به طوریکه پماد با ضخامت یک میلی متر روی سطح ضایعه را بپوشاند. گروه کنترل : تنها تحت درمان روتین قرار میگیرند.
General information
Not used
Used
nusedused
empty
typographical mistakes
typographical mistakes
empty
اشتباهات تایپی
اشتباهات تایپی
Intervention groups
#1
Intervention group: 0.05% calcipotriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions, so that the ointment with a thickness of one millimeter is applied on the lesion surface. . The patient is visited by a physician on a monthly basis the number and size of lesions, complications such as erythema and scaling around the lesion, pain, worsening of the lesions, and other associated symptoms. Treatment is continued for 2 months and if not treated for up to 4 months.
Intervention group: 0.005% calcipotriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions, so that the ointment with a thickness of one millimeter is applied on the lesion surface. . The patient is visited by a physician on a monthly basis the number and size of lesions, complications such as erythema and scaling around the lesion, pain, worsening of the lesions, and other associated symptoms. Treatment is continued for 2 months and if not treated for up to 4 months.
Intervention group: 0.050.005% calcipotriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions, so that the ointment with a thickness of one millimeter is applied on the lesion surface. . The patient is visited by a physician on a monthly basis the number and size of lesions, complications such as erythema and scaling around the lesion, pain, worsening of the lesions, and other associated symptoms. Treatment is continued for 2 months and if not treated for up to 4 months.
گروه مداخله: پماد کلسی پوتریول 0/05% علاوه بر درمان روتین به صورت دوبار در روز (هر 12 ساعت) توسط خود فرد یا والدین بیمار بر روی ضایعات استعمال می شود، به طوریکه پماد با ضخامت یک میلی متر روی سطح ضایعه را بپوشاند. بیمار به صورت ماهانه توسط پزشک ویزیت شده و در هر جلسه تعداد و اندازه ضایعات، عوارض مانند اریتم و پوسته ریزی اطراف ضایعه، درد، بدتر شدن ضایعات و سایر علائم همراه ثبت می شود. درمان 2 ماهه و در صورت عدم بهبود تا 4 ماه ادامه داده می شود.
گروه مداخله: پماد کلسی پوتریول 0/005% علاوه بر درمان روتین به صورت دوبار در روز (هر 12 ساعت) توسط خود فرد یا والدین بیمار بر روی ضایعات استعمال می شود، به طوریکه پماد با ضخامت یک میلی متر روی سطح ضایعه را بپوشاند. بیمار به صورت ماهانه توسط پزشک ویزیت شده و در هر جلسه تعداد و اندازه ضایعات، عوارض مانند اریتم و پوسته ریزی اطراف ضایعه، درد، بدتر شدن ضایعات و سایر علائم همراه ثبت می شود. درمان 2 ماهه و در صورت عدم بهبود تا 4 ماه ادامه داده می شود.
گروه مداخله: پماد کلسی پوتریول 0/05005% علاوه بر درمان روتین به صورت دوبار در روز (هر 12 ساعت) توسط خود فرد یا والدین بیمار بر روی ضایعات استعمال می شود، به طوریکه پماد با ضخامت یک میلی متر روی سطح ضایعه را بپوشاند. بیمار به صورت ماهانه توسط پزشک ویزیت شده و در هر جلسه تعداد و اندازه ضایعات، عوارض مانند اریتم و پوسته ریزی اطراف ضایعه، درد، بدتر شدن ضایعات و سایر علائم همراه ثبت می شود. درمان 2 ماهه و در صورت عدم بهبود تا 4 ماه ادامه داده می شود.
Protocol summary
Study aim
The effect of calcitriol ointment on the treatment of skin warts
Design
Two arm parallel-group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study is a randomized controlled clinical trial and all patients with cutaneous warts referred to dermatology clinic of Bu Ali Sina Hospital in Sari during the years 98 to 99 with inclusion criteria and excluding exclusion criteria were included. Individuals' personal information including age, sex, number of lesions, duration of the lesion is recorded in the questionnaire by the designers.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with cutaneous warts that are diagnosed by a dermatologist clinically or pathologically and need treatment.
- Over 4 years old
- Informed consent to enter the study
-The number of warts up to 20
Exclusion criteria:
- Children under 2 years, pregnant and lactating women
- Patients who are contraindicated for calcipotriol treatment.
- Facial genital warts
- Patients who do not consent to participate in the study.
- People who are allergic to topical vitamin D derivatives.
-Widespread warts that need further treatment.
Intervention groups
Intervention group: 0.005% calcitriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions so that the ointment with a thickness of one millimetre is applied on the lesion surface.
Control group: Only receive routine treatment.
Main outcome variables
Response to treatment is considered complete response, partial improvement (reduction in the number and in individual lesions size reduction) as of measurement and expression of percentage and no improvement, and 4 months after complete recovery of the patient, recurrence of lesions is examined.
General information
Reason for update
typographical mistakes
Acronym
IRCT registration information
IRCT registration number:IRCT20170818035762N2
Registration date:2020-02-17, 1398/11/28
Registration timing:registered_while_recruiting
Last update:2020-09-30, 1399/07/09
Update count:1
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4221 8021
Email address
a.kazeminejad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of calcipotriol ointment in the treatment of cutaneous wart
Public title
The effect of calcitriol ointment on skin warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cutaneous warts that are clinically or pathologically diagnosed by a dermatologist and need treatment
The number of warts up to 20
Minimum enrollment age is 4 years
Exclusion criteria:
People who are allergic to topical vitamin D derivatives.
Warts that need further treatment.
Age
From 4 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
First, according to the inclusion criteria, 56 patient will be selected by the available sampling method. Then, this 56 patient will be assigned to 2intervention and control groups. The blocking process will be done with the Rando allocation software. This software will create 14 blocks containing 4 patient and the samples will be grouped accordingly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study will be done like this the intervention group will receive routine treatment in addition to calcitriol ointment and the control group will receive only routine treatment. The researcher, patient, and individual analyzer will not be aware of the type of medication prescribed by the physician.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research.University Building number2 .Moalem Square.Sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.MAZUMS.REC.1398.1259
Health conditions studied
1
Description of health condition studied
Skin warts
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Response to treatment is considered complete response, relative improvement (reduction in number and size reduction in individual lesions) as measurement and expression of percentage and no improvement.
Timepoint
The patient is examined monthly by a dermatologist
Method of measurement
Based on clinical examination of dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.005% calcipotriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions, so that the ointment with a thickness of one millimeter is applied on the lesion surface. . The patient is visited by a physician on a monthly basis the number and size of lesions, complications such as erythema and scaling around the lesion, pain, worsening of the lesions, and other associated symptoms. Treatment is continued for 2 months and if not treated for up to 4 months.
Category
Treatment - Drugs
2
Description
Control group: This group will only receive routine treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Bou Ali Hospital
Full name of responsible person
Dr.Armaghan Kazeminejad
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Jouybar Road.Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱۴۸۱۵۷
Phone
+98 11 3304 4001
Email
publicrel@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
ُSari
Province
Mazandaran
Postal code
4414733971
Phone
+98 11 3304 4001
Email
publicrel@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.ArMarghan Kazeminejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
A.kazeminejad@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Armarghan KazemiNejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
A.kazeminejad@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Armaghan Kazeminejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
A.kazeminejad@mazums.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
No - There is not 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
Yes - There is 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
Only part of the data, such as information about the main outcome or the like, can be shared
When the data will become available and for how long
Start of access period 6 months after stablishing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It will only be available to researchers working in academic and scientific institutions
From where data/document is obtainable
Email to: A.kazeminejad@mazums.ac.ir
What processes are involved for a request to access data/document
After communicating with the email if available, data and results will be available