Evaluation of the effectiveness of topical palm leaf extract ointment in the treatment of flat warts in patients with flat warts referred to the dermatology clinic of the Center for Research and Training in Skin Diseases And Leprosy
Design
Patients with plane warts who refer to Center for Research and Training in Skin Diseases And Leprosy
This design is single-arm in phase 3 clinical trial and is on 30 patients
Settings and conduct
This ointment is prescribed for patients with warts in the skin and leprosy center and the patients are examined every two weeks and evaluated by image-j software. Finally, after administering the ointment to 30 patients, the results of this study are evaluated.
After proving that there is no allergic reaction in mice, the human ointment is tested for allergic reactions. First, the purpose of the study is explained to the patient and the patient signs the consent form and enters the study.
In the anterior region of patients with flat warts who are to be included in the study, an ointment of one to one centimeter is applied and covered with adhesive and examined after two days, if the patient suffers from complications such as burning and itching and No inflammation, treatment begins.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with warts; informed consent.
Exclusion criteria: pregnant women; the elderly; children under 2 years; using another medicine.
Intervention groups
Intervention group: palm leaf extract ointment is prescribed topically 3 times a day for two weeks to two months.
This study does not have a control group.
Main outcome variables
the size of plane warts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047352N1
Registration date:2021-01-16, 1399/10/27
Registration timing:registered_while_recruiting
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Azin Ayatollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 0880
Email address
a-ayatollahi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of palm leaf extract in the treatment of skin warts
Public title
Evaluation of the efficacy of Wart Over in the treatment of warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consents.
Patients with warts
Exclusion criteria:
Pregnant women
The elderly
Children under 2 years.
Use of another medicine.
Age
From 2 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth Floor Research and Technology Examination Central Organization of the University Corner of Quds Street, Keshavarz Boulevard,
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
IR.TUMS.VCR.REC.1399.483
Health conditions studied
1
Description of health condition studied
Plane Wart
ICD-10 code
B07.8
ICD-10 code description
Other viral warts
Primary outcomes
1
Description
The Size of Plane Wart
Timepoint
once every two weeks
Method of measurement
Image-j software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This drug (Wart Over) is administered topically to patients 3 times a day. The duration of treatment is between two weeks to two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases And Leprosy -Tehran university of Medical Science
Full name of responsible person
Azin Ayatollahi
Street address
No. 415,corner of Shahid Naderi St,Taleghani St., Center for Research and Training in Skin Diseases And Leprosy
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 0658 8897
Email
dermalab@tums.ac.ir
Web page address
http://crtsdl.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Center for Research and Training in Skin Diseases And Leprosy
Full name of responsible person
Azin Ayatollahi
Street address
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Fax
Email
azinay@gmail.com
Web page address
http://crtsdl.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center for Research and Training in Skin Diseases And Leprosy
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
Tehran University of Medical Sciences
Full name of responsible person
Azin Ayatollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1484976543
Phone
+98 21 8896 0880
Fax
Email
a-ayatollahi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azin Ayatollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1484976543
Phone
+98 21 8896 0880
Fax
Email
a-ayatollahi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azin Ayatollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1484976543
Phone
+98 21 8896 0880
Fax
Email
a-ayatollahi@sina.tums.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
Yes - There is 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
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 one year after printing results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only with the consent of the principal facilitator
From where data/document is obtainable
Dr.Ayatollahi
azinay@gmail.com
What processes are involved for a request to access data/document
Information will be sent within a month after the study facilitator agrees