The objective of present study is to investigate the effect of Verapamil (Calcium channel blocker) and Psuedoephedrin (antihistamine) in the treatment of hypertrophic scar. We select 60 patients with age between 15 to 60 years old who have two hypertrophic scars over two different parts of body which are the same size and shape clinically. Patients will be divided to two groups to receive Enalapril ointment 1% or pseudoephedrine ointment 1% on Hypertrophic scar in one scar and placebo on another for 6 months. We will Compare size of scar and severity of itching between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805191605N5
Registration date:2009-09-19, 1388/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-09-19, 1388/06/28
Registrant information
Name
Ali Akbar Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6097
Email address
mohamadiaa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research
Expected recruitment start date
2008-12-31, 1387/10/11
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of Enalapnl and Pseudoephedrine in the treatment of hypertrophic scar.
Public title
Comparison of effects of Enalapril and Pseudoephedrine in the treatment of hypertrophic scar.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 15-60 years, having two same hypertrophic scar in two part of
Exclusion criteria: history of drug hypersensitivity to study medications, pregnancy, presence of cardiovascular diseases
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences,Ghotb-eddin Burn Center
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Approval date
empty
Ethics committee reference number
4538-87-CT
Health conditions studied
1
Description of health condition studied
Hypertrophic scar
ICD-10 code
L91
ICD-10 code description
Hypertrophic disorders of skin
Primary outcomes
1
Description
burn site itching
Timepoint
monthly for following 6 months.
Method of measurement
A 5 point rating score (0=no itching, 4= very severe itching)
2
Description
Size of scar
Timepoint
monthly for 6 months
Method of measurement
In millimeter
Secondary outcomes
empty
Intervention groups
1
Description
Enalapril ointment 1% on Hypertrophic scar in one side and placebo on Hypertrophic scar in another side for 6 months
Category
Treatment - Drugs
2
Description
Pseudoephedrine ointment 1% on Hypertrophic scar in one side and placebo on Hypertrophic scar in another side for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotb-eddin Burn Center
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
Vice-chanceller of Research, Shiraz University of Medical Sciences
City
Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Burn reaserch center
Full name of responsible person
Ali akbar Mohammadi
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz .Burn reaserch center
City
Shiraz
Postal code
Phone
+98 71 1821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Burn reaserch center
Full name of responsible person
Masoomeh Kherad
Position
Bachelor in nursing
Other areas of specialty/work
Street address
Burn research center, Fakhrabad Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1820 8880
Fax
Email
burnres1@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)