infantile hemangioma is one of the most common tumors.developed in 4-5%of infantsthera.thrapetutic recommendation includes systemic or intralesional corticosteroids ,cryotherapy,chemotherapy,laysers and surgery with alot of sideeffects.patient with superficial hemangioma with no indications for systemic therapy from afzalipoor hospital clinic after getting satisfaction will become in this study randomized devide in two groupA&B group A will treat with topical propranolo0.1% &B with topical atenolol 0.1% three times aday with thin layerof this ointment.this study is double blind and keeping investigator and patient blind to treatment.monthly visiting in one year and getting photograph in each visits respons to thrapy measures with hemangioma severity table
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100935611N1
Registration date:2017-10-09, 1396/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
marjan tavakoli nejad
Name of organization / entity
kerman medical university
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8237
Email address
m.tavakoli@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparsion of efficacy of niosomal propranolo oint 0.1% versus atenolol oint 0.1% in the treatment of infantile hemangioma
Public title
comparsion of efficacy of niosomal propranolol oint 0.1% versus atenolol oint 0.1% in the treatment of infantile hemangioma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : age less than 12 month,definite diagnose of superficial hemangioma
exclusion criteria : sinus bradycardia, atrioventricular block, asthma, bronchitis, pneumonitis, maternal cardiac disease or other systemic disorder, allergy to beta blockers, history of tretmnent with beta blockers ,systemic corticosteroids, interferon, cyclophosphamide and vincristine
Age
From 10 days old to 1 year old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of kerman medical university
Street address
kerman- haftbagh road-kerman university of medical science\postal code:76169-13555 \phone:034-31325700
City
kerman
Postal code
76169-13555
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.KMU.REC.1396.1179
Health conditions studied
1
Description of health condition studied
Hemangioma
ICD-10 code
D18.0
ICD-10 code description
Haemangioma, any site
Primary outcomes
1
Description
size of lesion
Timepoint
monthly
Method of measurement
ruler
Secondary outcomes
1
Description
age
Timepoint
before starting study
Method of measurement
birth certification
2
Description
gender
Timepoint
before starting study
Method of measurement
asking
3
Description
place of lesion
Timepoint
before starting study
Method of measurement
looking
4
Description
time of beginning
Timepoint
before starting study
Method of measurement
asking
5
Description
vital signe
Timepoint
monthly
Method of measurement
examing
6
Description
lab test
Timepoint
first-second and third month
Method of measurement
laboratory
Intervention groups
1
Description
patient in group A treat with niosomal propranolol oint 0.1% three times aday applying thin layer of this ointment.and coming to clinic every month for one year and taking photo every month
Category
Treatment - Drugs
2
Description
patient in group B treat with niosomal atenolol oint 0.1% three times a day applying thin layer of this ointment and coming to clinic every month for one year and taking photo every month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic of afzalipour hospital of krman
Full name of responsible person
dermatology resident
Street address
kerman-imam khomeyni highway
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of kerman university of medical scieces
Full name of responsible person
Dr.Abbas pardakthy
Street address
shafas street-kerman
City
kerman
Grant name
---------
Grant code / Reference number
----------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research of kerman university of medical scieces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
kerman medical university
Full name of responsible person
Dr.maryam khalili
Position
dermatologist
Other areas of specialty/work
Street address
kerman afzalipoor hospital
City
kerman
Postal code
76169-13555
Phone
+98 343322225060
Fax
+98 33222763
Email
m-khalili@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kerman medical university
Full name of responsible person
Dr.saeedeh farajzadeh
Position
professor
Other areas of specialty/work
Street address
kerman afzalipoor hospital
City
kerman
Postal code
76169-13555
Phone
+98 34322225060
Fax
+98 33222763
Email
safaderm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
kerman medical university
Full name of responsible person
tavakoli nejad kermani-marjan
Position
dermatology resident
Other areas of specialty/work
Street address
kerman afzalipoor hospital
City
kerman
Postal code
7618777911
Phone
+98 343322225060
Fax
+98 33222763
Email
marjanta_66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)