Protocol summary

Summary
Aim of survey: comparative survey on the effect of verapamil and triamcinolone Hypertrophic scar and keloid treatment. Study design: coincidental, one center, first stage of case control study. Population of study: patients with hypertrophic scar and keloid with no another treatment. Sample size: 25 case and 25 control. Study intervention: intra lesional injection of verapamil and triamcinolon. Primary outcome: treatment of hypertrophic scar and keloid.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010425539N5
Registration date: 2016-02-07, 1394/11/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Abbas Zamanian
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 1989
Email address
a.zamanian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative survey on the effect of intralesional verapamil and triamcinolon on Hypertrophic scar and keloid in Rasul Aakram hospital in 94-95
Public title
Comparing the effect of Verapamil and triamcinolon in Hypertrophic scar treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with hypertrophic scar and keloid which had not any other treatment and after accept of survey condition to come montly for enjection.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Comittee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Adjacent to Milad Tower, Hemmat highway
City
Tehran
Postal code
19922347512
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.IUMS.REC.1394.9311166004

Health conditions studied

1

Description of health condition studied
Hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
Keloid scar

Primary outcomes

1

Description
Hypertrophic scar
Timepoint
The month 0, 1, 2 during treatment and 1 month after treatment
Method of measurement
The highest elevation of hypertrophic scar with calliper and ruler

Secondary outcomes

1

Description
Patient satisfaction from treatment
Timepoint
After treatment
Method of measurement
The percentage and score of the patient to treatment

Intervention groups

1

Description
Intralesional verapamil, vial 2/5 mg, monthly for 3months.
Category
Treatment - Drugs

2

Description
Intralesional triamcinolone, injectable suspension 40mg, 50% concentration, monthly for 3 month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Maryam Nokandeh
Street address
Rasool Akram Hospital, Niayesh Street, Shahr Ara, Sattarkhan Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Leila Irani
Street address
Iran University of Medical Sciences, Adjacent to the Milad Tower, Hemat Highway
City
Tehran
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, Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Nokandeh
Position
Dematology resident
Other areas of specialty/work
Street address
Hazrat Rasool Akram Hospital, Niayesh Street, Shahr Ara, Sattarkhan, Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 64351
Fax
+98 21 6650 6864
Email
Nokandeh_maryam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Zamanin
Position
Associate professor, dermatologist
Other areas of specialty/work
Street address
Hazrat rasool akram hospital, niayesh street, shahr ara, sattar khan streer,
City
Tehran
Postal code
1445613131
Phone
+98 21 64351
Fax
+98 21 6650 6864
Email
Abbas_ zamanian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Nokandeh
Position
Dermatology resident
Other areas of specialty/work
Street address
Hazrat Rasool Akram Hospital, Niayesh street, Shahr Ara, Sattar Khan street
City
Tehran
Postal code
1445613131
Phone
+98 21 64351
Fax
+98 21 6650 6864
Email
Nokandeh_Maryam@ yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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