Protocol summary

Study aim
Effect of topical Betamethasone ointment on inflammation after Cryotherapy in the treatment of skin wart
Design
Clinical trial with control group, double-blind,not randomized
Settings and conduct
The lesions are treated with cryotherapy on both sides of the body so that they extend up to 2 mm around the lesion. Topical betamethasone is then applied to the lesions on one side after cryotherapy, and the opposite side of the placebo ointment is applied to a tube of the same shape, size, and color. Also, the researcher does not know the type of ointment. The site of the operation is in Bouali Hospital of Sari city, patients refer to a dermatology clinic
Participants/Inclusion and exclusion criteria
Entry requirement 1.Patients with skin wart who have been diagnosed clinically or pathologically by a dermatologist and have cryotherapy indications 2.Patients over 2 years of age. 3. Have a conscious desire to enter the study. 4.the maximum number of warts is up to 20 No entry condition 1.Children under 2 years of age, pregnant and lactating women 2.People treated with systemic medications that interfere with wound healing or taking immunosuppressive drugs 3.Patients who have contraindications for cryotherapy 4.Patients who don't want to participating in the study 5.Patients who have used topical medications other than emollients in the past month 6. People who are allergic to betamethasone or topical steroids 7.Patients with impaired wound healing, such as diabetes. 8.Distributed and resistant warts that need other treatment
Intervention groups
In the first group, lesions on a limb, betamethasone, were used In the second group, lesions on other organs pelacebo were used
Main outcome variables
Symptoms include pain, erythema, blisters, and hyperpigmentation and scarring during the first 48 hours, a week, and two weeks after cryotherapy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170818035762N3
Registration date: 2020-05-30, 1399/03/10
Registration timing: registered_while_recruiting

Last update: 2020-05-30, 1399/03/10
Update count: 0
Registration date
2020-05-30, 1399/03/10
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
2019-04-04, 1398/01/15
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of topical betamethasone valerate on post-cryotherapy inflammation in cutaneous wart treatment
Public title
betamethasone valerate on post-cryotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with skin wart who are diagnosed by a dermatologist clinically or pathologically and have cryotherapy indications. Patients over 2 years of age They have a conscious consent to enter the study the maximum number of warts is up to 20
Exclusion criteria:
pregnant and lactating women People treated with systemic medications that interfere with wound healing or immuno suppressive drugs Patients who have contraindications for cryotherapy Patients who have used topical medications other than emollients in the past month People who are allergic to betamethasone or topical steroids Patients with wound healing disorders such as diabetes Distributed and resistant warts that need further treatment
Age
From 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
we use medicine on one limb and use placebo. on another limb. executor of plan and Patient don't know which limb take the medicine.
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
Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.MAZUMS.REC.1398.298

Health conditions studied

1

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

Primary outcomes

1

Description
tolerance of pain to cryotherapy treatment
Timepoint
Day 1,7 and 14
Method of measurement
Vas scale

Secondary outcomes

1

Description
Illness severity
Timepoint
At the beginning of the study
Method of measurement
Based on the number of warts

2

Description
Duration of illness
Timepoint
At the beginning of the study
Method of measurement
Number of days before starting treatment

3

Description
Eritrea
Timepoint
The second, eighth and fifteenth day after starting treatment
Method of measurement
Based on the examination

4

Description
Blisters
Timepoint
The second, eighth and fifteenth day after starting treatment
Method of measurement
Based on the examination

5

Description
Scar
Timepoint
The second, eighth and fifteenth day after starting treatment
Method of measurement
Based on the examination

Intervention groups

1

Description
Intervention group: In our study, patients with skin warts in two different organs were included. The first intervention group was given one of the organs with betamethasone valrate after cryotherapy.
Category
Treatment - Drugs

2

Description
Control group: Control group: In our study, patients enter the study who have skin warts in two different organs. In the second intervention group, we used placebo on an organ that did not use betamethasone valrate
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bo Ali Sina Hospital in Sari
Full name of responsible person
Armaghan Kazeminezhad
Street address
Sari. The beginning of Ghaem Shahr road. Bu Ali Sina Hospital
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
Downstairs pharmacy 13 Aban. Moalm Square. Sari.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Armaghan Kazeminezhad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Mazandaran University of Medical Sciences ,Sari , Mazandaran
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 4221 8021
Fax
+98 11 4221 8022
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.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

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is 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
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 the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
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
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