A comparative study of the effect of intralesional triamcinolone acetonide and intralesional verapamil in the treatment of hypertrophic scars and keloids
This study is a randomized double blind clinical trial on 50 patients with two or more keloids referred to Razi Hospital during 2015-16.
Patients who will meet the criteria will included in the study using convenience sampling method and their scars will be randomly allocated using block randomization to receive intralesional injection of either verapamil or triamcinolone. Patients are included if they have two or more keloids under 5 years duration, without any history of prior treatment. Patients with systemic disorders and women during pregnancy and lactation will be excluded.
Intralesional injections will performed. 1 milliliter was the maximum
permissible injected volume of triamcinolone (concentration
40 milligram per milliliter) and verapamil (concentration
2.5 milligram per milliliter). The drugs are administered at 3 week intervals till the scar flattened or for a maximum period of 6 months. The patients will examined every 3 weeks till 6 months and will reevaluate after 3 months to check for any recurrence.
The clinical assessment of the scar is based on the Vancouver Scar Scale and patient's satisfaction. The scale scores the scars on four parameters namely pigmentation, scar height, vascularity and pliability.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010525871N1
Registration date:2016-06-17, 1395/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-17, 1395/03/28
Registrant information
Name
Pardis Sasani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8855 0680
Email address
p_sasani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-04-02, 1395/01/14
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of intralesional triamcinolone acetonide and intralesional verapamil in the treatment of hypertrophic scars and keloids
Public title
Comparison of the effect of verapamil with corticosteroids in the treatment of keloids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years; two or more hypertrophic scars or keloids; total area less than 10 square centimeters; no previous treatment; scars under 5 years duration
Exclusion criteria: Facial keloids; infection or ulcer, in or near the scar; pregnancy and lactation; patients with systemic illness like diabetes mellitus, mental disorder, cancer and cardiac disease; dark pigmented skin
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Tehran University of Medical sciences
Street address
Vice chancellor for research, No 23, Dameshgh Street, Felestin Avenue, Keshavarz Boulevard.
City
Tehran
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.TUMS.REC.1394.2200
Health conditions studied
1
Description of health condition studied
Keloid
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Scar pigmentation
Timepoint
Before intervention, every 3 weeks for a period of 6 months, 3 months after the end of the intervention
Method of measurement
Observation and scoring based on Vancouver Scar Scale
2
Description
Height of the scar
Timepoint
Before intervention, every 3 weeks for a period of 6 months, 3 months after the end of the intervention
Method of measurement
Using ruler and scoring based on Vancouver Scar Scale
3
Description
Vascularity
Timepoint
Before intervention, every 3 weeks for a period of 6 months, 3 months after the end of the intervention
Method of measurement
visual inspection and the rate of refill after blanching and scoring based on Vancouver Scar Scale
4
Description
Scar pliability
Timepoint
Before intervention, every 3 weeks for a period of 6 months, 3 months after the end of the intervention
Method of measurement
Palpation and scoring based on Vancouver Scar Scale
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
At the end of the study
Method of measurement
Asking the patients about any alternation in side effects of the keloids e.g. pain and pruritus
Intervention groups
1
Description
Intervention group: Intralesional injection of maximum 1 milliliter of verapamil hydrochloride (2.5 milligram per milliliter) every 3 weeks till the scar flattened or for a maximum period of 6 months.
The injections will be made at 1 centimeter interval in the lesion with an insulin syringe and 30 gauge needle to achieve complete and evenly distributed blanching of the lesion at endpoint.
Category
Treatment - Drugs
2
Description
Control group: Intralesional injection of maximum 1 milliliter of triamcinolone acetonide (40 milligram per milliliter) every 3 weeks till the scar flattened or for a maximum period of 6 months. The injections will be made at 1 centimeter interval in the lesion with an insulin syringe and 30 gauge needle to achieve complete and evenly distributed blanching of the lesion at endpoint.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Skin Hospital
Full name of responsible person
Pardis Sasani, Dermatology resident, Tehran University of Medical Sciences
Street address
Razi Skin Hospital, Vahdat e eslami Square, Vahdat e eslami Avenue.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor fpr research of Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Street address
415, Taleghani Avenue
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 fpr research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pardis Sasani
Position
Doctor of Medicine/ Dermatology resident
Other areas of specialty/work
Street address
Razi Skin Hospital, Vahdat e eslami Square.
City
Tehran
Postal code
Phone
+98 21 5560 9952
Fax
Email
pardis_sasani@yahoo.com; p_sasani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Robabeh Abedini
Position
Assistant Professor/Dermatologist
Other areas of specialty/work
Street address
Razi Skin Hospital, Vahdat e eslami Square.
City
Tehran
Postal code
Phone
+98 21 5560 9952
Fax
Email
r.abed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pardis Sasani
Position
Doctor of Medicine/ Dermatology resident
Other areas of specialty/work
Street address
Razi Skin Hospital
City
Tehran
Postal code
Phone
+98 21 5560 9952
Fax
Email
pardis_sasani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)